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Charles River - Safety Assessment

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At Charles River, we take a comprehensive approach to assessing the safety of a potential new human therapy using multiple disciplines including toxicology, pharmacology, drug metabolism, toxicokinetics and chemistry.

Leveraging a global network of AAALAC-accredited preclinical facilities, we design and perform in vitro and in vivo safety programs to best characterize potential human drug toxicity. Our staff of toxicologists, pathologists, veterinary surgeons, regulatory specialists and support personnel has a strong mechanistic understanding of drug toxicity, bolstering our ability to determine potential risk factors early in the drug development process.

Many of our scientists have served on or are currently participating in regulatory and industry body working groups, shaping the future of our studies. Because we are on the front lines, we ensure that our products, services and processes keep pace with the... Show more »

At Charles River, we take a comprehensive approach to assessing the safety of a potential new human therapy using multiple disciplines including toxicology, pharmacology, drug metabolism, toxicokinetics and chemistry.

Leveraging a global network of AAALAC-accredited preclinical facilities, we design and perform in vitro and in vivo safety programs to best characterize potential human drug toxicity. Our staff of toxicologists, pathologists, veterinary surgeons, regulatory specialists and support personnel has a strong mechanistic understanding of drug toxicity, bolstering our ability to determine potential risk factors early in the drug development process.

Many of our scientists have served on or are currently participating in regulatory and industry body working groups, shaping the future of our studies. Because we are on the front lines, we ensure that our products, services and processes keep pace with the rapid evolution of science, technology and the ever-changing needs of our clients' product development.

Animal Welfare, Scientific Pride and Ethical Business Practices

At Charles River, ethical conduct includes the humane care of research animals. Humane care is not only a moral imperative, it is a scientific necessity. The treatment of research animals has a discernible effect on the success of our clients' programs, and our goal is to ensure that every employee has the necessary skills to handle our animals with care and compassion. Our dedication to scientific excellence, devotion to animal welfare and our insistence on integrity and ethical conduct is reflected in all of our business practices.

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Xenograft Models
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Dose Range Finding (DRF) Studies
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Premarket Approval Application
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In vitro Percutaneous Absorption Studies
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In vitro Skin Models
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In vitro Skin Irritation/Sensitization Testing
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Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River.

Skin Sensitization Assays:
* DPRA (direct peptide... Show more »

Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River.

Skin Sensitization Assays:
* DPRA (direct peptide reactivity assay)
* KeratinoSens and LuSens
* MUSST
* hCLAT
* In silico (QSAR)
* LLNA (local lymph node assay)
* GPMT (guinea pig maximization test)
* Buehler assay (contact sensitization)
* DTH (delayed-type hypersensitization)

Irritation Assays:
* SkinEthic EpiSkin® skin irritation (OECD 439)
* MatTek EpiOcular® eye irritation (OECD 492)
* Bovine cornea and opacity permeability (BCOP – OECD 437)
* Hen’s Egg Test (HET)-CAM ocular irritation
* Ocular and dermal acute non-rodent
* Acute dermal rodent

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In vivo Toxicity Testing
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In vitro Immunotoxicity Testing
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Biopharmaceutical Characterization
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Research Record Retention
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Research records and materials are vital to your drug development program. It is fundamental that they be properly stored in an GxP compliant archive facility that enables reliable and rapid retrieval.
Our facilities and services provide short- and long-term GxP-compliant data and sample archiving services in support of... Show more »

Research records and materials are vital to your drug development program. It is fundamental that they be properly stored in an GxP compliant archive facility that enables reliable and rapid retrieval.
Our facilities and services provide short- and long-term GxP-compliant data and sample archiving services in support of preclinical and clinical studies for government and private sector businesses, organizations and consortia.
By archiving with Charles River you get:
- Expedited retrieval of records for agency/client inspections
- Site visits and on-site access to Study Directors
- Full service record keeping from inception to destruction

Facilities and Services:
- Over 500,000 cubic feet of controlled, dedicated space
- Several layers of security to limit access as well as safeguard essential study materials under GLP conditions
- Storage conditions include room temperature, refrigerated, frozen at -20°C or -70°C and cryostorage at -196°C
- Periodic inventory and materials inspections
- Hard copy transfer to CD
- Microform printing
- Pick-up and delivery services for both short-term and long-term storage

Materials:
- Paper data, records and reports
- Electronic media
- Microform

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Neuropathology
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Charles River combines experienced pathologists with a highly trained technical staff and well-designed laboratories to offer pathology services in the specialized area of neuropathology. We provide assistance in study design, development strategies and regulatory submissions for a wide variety of compounds affecting the nervous... Show more »

Charles River combines experienced pathologists with a highly trained technical staff and well-designed laboratories to offer pathology services in the specialized area of neuropathology. We provide assistance in study design, development strategies and regulatory submissions for a wide variety of compounds affecting the nervous system. Each year, our scientists conduct over 30 GLP-compliant neuropathology studies in support of FDA and EPA regulatory submissions.

  • Whole-body perfusion
  • Specialized nerve tissue embedding
  • Specialized staining capabilities
  • Electron microscopy (transmission electron microscopy and scanning electron microscopy)
  • Morphometric analysis
  • Immunohistochemistry
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Electron Microscopy
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Charles River offers full-service GLP and non-GLP electron microscopy (EM) with both scanning and transmission capabilities in multiple locations. Our experienced staff is available to provide guidance in protocol design for the most appropriate collection, preparation and evaluation of biologic samples to ensure sample... Show more »

Charles River offers full-service GLP and non-GLP electron microscopy (EM) with both scanning and transmission capabilities in multiple locations. Our experienced staff is available to provide guidance in protocol design for the most appropriate collection, preparation and evaluation of biologic samples to ensure sample integrity.
In addition to our microscopy capabilities, we have extensive imaging laboratory services that can support your research and development efforts, including DXA, QCT, micro-CT and digital radiography.

Applications:
- Ultrastructural pathology
- Quantification of peroxisomes
- Viral particle identification, characterization and tabulation
- Cell culture contamination identification
- Evaluation of tissue/medical device interface
- Characterization of red blood cell morphology

Services:
- Transmission electron microscopy (TEM)
- Scanning electron microscopy (SEM)
- Light microscopy
- Dual-energy X-ray absorptiometry (DXA)
- Quantitative computed tomography (QCT)
- Micro-computed tomography (Micro-CT)
- Digital radiography

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Stereology
Price on request

We offer a full range of services for discovery and GLP-compliant studies from conception and design through to data analysis. We are ready to help you with a wide range of measurements, including cell counts, cell or tissue volumes, and length and surface area determination for all tissue sizes from any species.

We offer a full range of services for discovery and GLP-compliant studies from conception and design through to data analysis. We are ready to help you with a wide range of measurements, including cell counts, cell or tissue volumes, and length and surface area determination for all tissue sizes from any species.

  • Analysis directly on scanned slides using Visiopharm®, GLP-validated software
  • Plastic and frozen sectioning capability
  • Systematic uniform random sampling and analysis of tissues of any size from all species
  • Counting objects using physical or optical dissectors
  • Estimation of volume for tissues, tissue compartments, or cells
  • Estimation of surface area and length
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Image Analysis
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Our state-of-the-art facilities house image analysis systems that perform all of the standard and user-defined static and dynamic measurements for bone. The dynamic measurements can be completed with or without fluorochrome labels.
Our facilities also provide a wide range of image analysis techniques for other tissues.... Show more »

Our state-of-the-art facilities house image analysis systems that perform all of the standard and user-defined static and dynamic measurements for bone. The dynamic measurements can be completed with or without fluorochrome labels.
Our facilities also provide a wide range of image analysis techniques for other tissues. Whole-slide scanning with online slide viewing capabilities is available, as are whole-slide morphometric analysis and stereological analysis on slides scanned using GLP-validated Visiopharm® software.
Each system is operated by highly trained technical staff supervised by pathologists board certified by the American College of Veterinary Pathologists, Royal College of Pathologists and European College of Veterinary Clinical Pathology.

  • Small intestine villus length, crypt depth and villus/crypt ratios
  • Image analysis of immunohistochemically or histochemically stained slides, including number of labeled cells, area of positive staining and tissue composition analysis
  • Determination of cell proliferation index (Ki67, BrdU, PCNA) or apoptotic index (caspase-3, TUNEL)
  • Diameter of stented blood vessels
  • Extent of infarcts in the heart
  • Capillary angiogenesis in cutaneous wound defects, including microvascular density quantification
  • Goblet cell number in the respiratory tract
  • Adult and juvenile rat cerebellar and cerebral measurements
  • Axon and nerve fiber changes in peripheral nerves
  • Skeletal muscle characterization
  • Pulmonary fibrosis assessment
  • Thyroid gland epithelial height and colloid area for endocrine disruptor assessment
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In situ Hybridization (ISH)
In Situ Hybridization
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  • RNAscope® technology
  • Fluorescein probe
  • Chromogenic probe
  • Biotin probe
  • Digoxigenin probe
  • 33P-labeled probes
  • Autoradiographic emulsion detection
  • Microautoradiography detection
  • RNAscope® technology
  • Fluorescein probe
  • Chromogenic probe
  • Biotin probe
  • Digoxigenin probe
  • 33P-labeled probes
  • Autoradiographic emulsion detection
  • Microautoradiography detection
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Immunohistochemistry (IHC)
Price on request
  • Safety assessments for approximately 70 humanized, chimeric or murine monoclonal antibodies annually
  • Protocol development for over 80 different antibodies in a variety of species
  • Experience with unconjugated antibodies, antibodies conjugated to a variety of substances and Fab fragments
  • Techniques to reduce or eliminate... Show more »
  • Safety assessments for approximately 70 humanized, chimeric or murine monoclonal antibodies annually
  • Protocol development for over 80 different antibodies in a variety of species
  • Experience with unconjugated antibodies, antibodies conjugated to a variety of substances and Fab fragments
  • Techniques to reduce or eliminate the binding of secondary reagents to endogenous immunoglobulin, even when the tissue is of the same species as the immunoglobulin
  • Reproducibility of immunohistochemical techniques in conjunction with morphometric and stereological analyses
  • QIHC-certified staff using state-of-the-art automated staining instruments
  • Double IHC staining
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Tissue Cross Reactivity Studies
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Charles River can support your monoclonal antibody research with our expertise in the initial stages of safety assessment for therapeutic antibodies targeted for use in humans. We hold a full range of tissues from various animal species, including human.
For immunohistochemistry-based tissue cross-reactivity studies, we provide... Show more »

Charles River can support your monoclonal antibody research with our expertise in the initial stages of safety assessment for therapeutic antibodies targeted for use in humans. We hold a full range of tissues from various animal species, including human.
For immunohistochemistry-based tissue cross-reactivity studies, we provide efficiency of scale in full compliance with Good Laboratory Practice (GLP) regulations and interpretation of findings, and can represent you in presenting to the applicable regulatory agencies.

Tissue-Based Biomarkers:
We provide correlative studies that are designed as an adjunct to clinical trials. These studies assist in determining whether a drug is reaching the intended target and whether the drug will work the same way in humans as it has in animals. Because each project has its own unique requirements, our pathologists and scientists will work closely with you to identify which tissue-based biomarkers to assess.

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Anatomic Pathology
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With full-service pathology and histology laboratories and facilities strategically positioned across the United States, Canada and Europe, we have both the infrastructure and the scientific expertise to readily meet the evolving needs of our clients. We offer services ranging from traveling necropsy teams to routine toxicity... Show more »

With full-service pathology and histology laboratories and facilities strategically positioned across the United States, Canada and Europe, we have both the infrastructure and the scientific expertise to readily meet the evolving needs of our clients. We offer services ranging from traveling necropsy teams to routine toxicity histopathological assessments. Our global pathology network has unparalleled capacity, allowing us to perform the histologic processing and histopathologic evaluation of several million tissue samples every year.

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Veterinary Pathology
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Charles River offers a complete range of clinical pathology laboratory services to support animal models, discovery and/or preclinical studies. Our clinical pathology laboratory staff has extensive knowledge of animal and human hematology, coagulation, clinical biochemistry and urinalysis. In addition, specialized pathology... Show more »

Charles River offers a complete range of clinical pathology laboratory services to support animal models, discovery and/or preclinical studies. Our clinical pathology laboratory staff has extensive knowledge of animal and human hematology, coagulation, clinical biochemistry and urinalysis. In addition, specialized pathology laboratory services are available to meet your assay or biomarker development needs for specific research requirements or drug safety studies.
Our staff, which includes pathologists certified by the American College of Veterinary Pathologists and the European College of Veterinary Clinical Pathology, has expertise across the spectrum of major therapeutic areas and routinely assesses and interprets data from regulatory and investigative/research studies. With nine state-of-the-art clinical pathology labs, we can support all stages of human and veterinary drug development. We conduct research in accordance with the current standards of Good Laboratory Practice (GLP).

Capabilities - Standard Platforms:
- Hematology and coagulation
- Clinical biochemistry (including microsampling)
- Urinalysis
- Bone marrow and bronchoalveolar evaluation
- Blood gas
- Platelet function

Capabilities - Specialized Platforms
- Cytology (CSF, BAL, etc.)
- Hormones
- Cytokines
- Hemolytic studies
- Assay/Method development and validation

Scientific Expertise:
- Broad experience in regulatory assessment and interpretation of clinical pathology data from regulatory and investigative/research studies
- Clinical pathology report preparation
- Scientific cross-linking and integrated reports
- Bridging of clinical medicine, laboratory medicine and basic sciences
- Contribution to study design, special investigations, health authorities’ questions and regulatory documents (e.g., expert reports, IBs, CTDs)

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IND-Enabling Studies
Price on request

Learn through our years of IND research experience, unique range of services and best-in-class expertise how we can help you successfully initiate and complete your IND-enabling program. With our ongoing efforts to improve upon our internal processes and continued focus on scientific excellence and guidance, we are pleased to offer a highly cost-effective IND program for our clients.

Learn through our years of IND research experience, unique range of services and best-in-class expertise how we can help you successfully initiate and complete your IND-enabling program. With our ongoing efforts to improve upon our internal processes and continued focus on scientific excellence and guidance, we are pleased to offer a highly cost-effective IND program for our clients.

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In vivo Skin Irritation/Sensitization Testing
Price on request

Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River.

Skin Sensitization Assays:
* DPRA (direct peptide... Show more »

Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River.

Skin Sensitization Assays:
* DPRA (direct peptide reactivity assay)
* KeratinoSens and LuSens
* MUSST
* hCLAT
* In silico (QSAR)
* LLNA (local lymph node assay)
* GPMT (guinea pig maximization test)
* Buehler assay (contact sensitization)
* DTH (delayed-type hypersensitization)

Irritation Assays:
* SkinEthic EpiSkin® skin irritation (OECD 439)
* MatTek EpiOcular® eye irritation (OECD 492)
* Bovine cornea and opacity permeability (BCOP – OECD 437)
* Hen’s Egg Test (HET)-CAM ocular irritation
* Ocular and dermal acute non-rodent
* Acute dermal rodent

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Environmental Impact Assessment
Price on request

The Environmental Risk Assessment (ERA) service from Charles River is based on European guidelines; however, it can be applied to other submissions in differing countries and regulatory agencies. We have experience in ERA for all industry product sectors, including human pharmaceuticals.

The Environmental Risk Assessment (ERA) service from Charles River is based on European guidelines; however, it can be applied to other submissions in differing countries and regulatory agencies. We have experience in ERA for all industry product sectors, including human pharmaceuticals.

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Endocrine Disruptor Screening
Price on request

With new EPA endocrine disruptor regulations, proper testing is more important than ever. Whether you require Tier I or Tier II tests, our experts can help at every stage, from initial data gathering through evaluation and interpretation for hazard/risk assessment. All studies are validated and performed according to GLP... Show more »

With new EPA endocrine disruptor regulations, proper testing is more important than ever. Whether you require Tier I or Tier II tests, our experts can help at every stage, from initial data gathering through evaluation and interpretation for hazard/risk assessment. All studies are validated and performed according to GLP principles.

Sample capabilities:
- In vitro assays
- Androgen receptor binding
- Aromatase (human recombinant)
- Estrogen receptor binding
- Estrogen receptor transcriptional activation
- Steroidogenesis

In vivo assays:
- Amphibian metamorphosis
- Fish short-term reproduction
- Hershberger
- Pubertal female
- Pubertal male
- Uterotrophic

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Neurotoxicity Testing
Price on request

The neurotoxicology program at Charles River encompasses a broad range of products, including pharmaceuticals, biopharmaceuticals, chemicals and agrochemicals, in both rodent and nonrodent species. With over two decades of experience, we have a valuable historical control database for tests in developmental neurotoxicology. We... Show more »

The neurotoxicology program at Charles River encompasses a broad range of products, including pharmaceuticals, biopharmaceuticals, chemicals and agrochemicals, in both rodent and nonrodent species. With over two decades of experience, we have a valuable historical control database for tests in developmental neurotoxicology. We also have a knowledgeable staff of scientists and technical personnel who routinely perform neurotoxicity screening tests for possible on- or off-target effects, specialized target tissue delivery, expanded investigative studies and developmental neurotoxicity.

Capabilities include:
- Neurobehavior, including assays of locomotor activity, rotarod forced activity, water maze learning and memory testing, auditory startle habituation and functional observational batteries
- Neurochemistry, including cholinesterase assays in red blood cell, plasma and brain samples, as well as quantification of endogenous levels of neurotransmitters
- Neuropathology, including in situ perfusion, morphometry, stereology and qualitative neuropathological evaluations
- Drug abuse/dependence liability testing

Dose Routes:
- Standard dose routes
- Routine and specialized routes of parenteral injection or infusion and target-tissue administration
- Intravenous
- Subcutaneous
- Epidural
- Intrathecal
- Intracerebroventricular
- Intracerebral
- Intracisternal

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In vitro Genetic Screening
Price on request

Charles River offers screening assays to support our clients during their hit-to-lead and lead optimization phases of drug discovery. These assays are highly predictive of the regulatory assays and can be used to support go/no-go decisions. Because of low compound requirement, screening assays are the ideal tool at stages where... Show more »

Charles River offers screening assays to support our clients during their hit-to-lead and lead optimization phases of drug discovery. These assays are highly predictive of the regulatory assays and can be used to support go/no-go decisions. Because of low compound requirement, screening assays are the ideal tool at stages where compound synthesis is not yet optimized or more data is needed before committing resources to further compound development.

In Vitro Assays:
- Bacterial Mutation Test (OECD 471)
- Ames MPF, Ames II, mini Ames
- Mammalian Cell Gene Mutation Test (HPRT Gene, OECD 476)
- Mammalian Chromosome Aberration Test (OECD 473)
- Mammalian Cell Gene Mutation Test (TK Gene, OECD 490)
- Mammalian Cell Micronucleus Assay (OECD 487)
- Fluorescence In Situ Hybridization (FISH)

In Vivo Assays:
- Mammalian Alkaline Comet Assay (OECD 489)
- Rodent Micronucleus Test (OECD 474)
- Unscheduled DNA Synethesis (OECD 486)
- Bone Marrow Chromosome Aberration (OECD 475)
- Pig-a Gene Mutation Assay
- Immunofluorescent Antikinetochore (CREST Staining)
- Combined Comet/Micronucleus Assay

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Bone Safety Studies
Price on request

Charles River offers a fully integrated service with a team of scientists, pathologists, veterinarians and surgeons in the field of musculoskeletal research. Our team of musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal... Show more »

Charles River offers a fully integrated service with a team of scientists, pathologists, veterinarians and surgeons in the field of musculoskeletal research. Our team of musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system.
This integrated approach allows the comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the effects of new orthobiologic applications.

Models include:
- Gonadectomy (ovariectomy and orchiectomy)-induced bone loss for osteoporosis drug testing
- 5/6 nephrectomy model
- TPTx (thyroparathyroidectomy) model
- Schenk model in weanling rats (screen for anti-resorptive agents)
- Bone defect models
- Orthopedic models
- Osteoarthritis models
- Rheumatoid arthritis models

Non-GLP efficacy models are also available for your early research.

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the effects of new orthobiologic applications. Non-GLP efficacy models are available for early research.

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In vivo Acute Toxicity Studies
Price on request

Charles River offers competitively priced non-GLP acute toxicology services. Our streamlined protocols, redesigned in-life procedures and targeted reports allow us to offer scientific rigor with an operationally efficient service. Redesigning our approaches has translated directly into savings for our sponsors, without... Show more »

Charles River offers competitively priced non-GLP acute toxicology services. Our streamlined protocols, redesigned in-life procedures and targeted reports allow us to offer scientific rigor with an operationally efficient service. Redesigning our approaches has translated directly into savings for our sponsors, without compromising objectives and quality.

Our streamlined processes and documentation mean less paperwork and duplication as well as reduced and more efficient handoffs for data collection and review. We have flexible and dedicated staff available to perform multiple functions resulting in simplified processes. Client interactions are simplified as well, with preset study designs resulting in reduced review cycles for protocol and report.

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PK/PD Data Analysis
Price on request

Charles River provides bioanalytical support for samples generated in toxicology studies, and the resultant test article/item concentration data can be interpreted by our pharmacokinetics staff utilizing industry-standard WinNonlin® software using noncompartmental and compartmental approaches. We offer this as an integrated... Show more »

Charles River provides bioanalytical support for samples generated in toxicology studies, and the resultant test article/item concentration data can be interpreted by our pharmacokinetics staff utilizing industry-standard WinNonlin® software using noncompartmental and compartmental approaches. We offer this as an integrated service, where all aspects of the study are managed within our laboratories, or as a stand-alone service, which enables analysis of concentration data generated elsewhere by the sponsor.
Toxicokinetic parameter estimation output includes a comprehensive interpretation of the data, as required. In addition, we can address preclinical-to-clinical considerations (e.g., allometric scaling) when planning first-in-human studies.

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Toxicology
Price on request

Charles River performs general toxicology safety evaluation studies for the pharmaceutical, biopharmaceutical, veterinary, chemical, agrochemical and consumer product industries. Our wealth of knowledge allows us to advise and conduct standard and novel toxicology study designs, as well as deal with unexpected findings or toxicity... Show more »

Charles River performs general toxicology safety evaluation studies for the pharmaceutical, biopharmaceutical, veterinary, chemical, agrochemical and consumer product industries. Our wealth of knowledge allows us to advise and conduct standard and novel toxicology study designs, as well as deal with unexpected findings or toxicity issues during the course of a program.

Routes of administration:
- Dermal
- Intra-articular
- Intranasal
- Intravaginal and intrapenile
- Ocular
- Oral (gavage, diet and capsule)
- Parenteral (intravenous, subcutaneous, intradermal, intramuscular and intraperitoneal)
- Rectal

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Carcinogenicity/Tumorigenicity Testing
Price on request

Our carcinogenicity toxicology studies in rodents and toxicity studies in both rodent and nonrodent species (including the minipig) are performed in full compliance with Good Laboratory Practice (GLP) regulations. In addition, all protocols are designed to meet the regulatory requirements of the various countries in which the products are to enter clinical trials or be marketed.

Our carcinogenicity toxicology studies in rodents and toxicity studies in both rodent and nonrodent species (including the minipig) are performed in full compliance with Good Laboratory Practice (GLP) regulations. In addition, all protocols are designed to meet the regulatory requirements of the various countries in which the products are to enter clinical trials or be marketed.

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In vitro Phototoxicity Testing
Price on request

Our scientists have pioneered the quantitative study of cutaneous photobiology by designing instruments, techniques and protocols now accepted as industry standards. Expert knowledge of light sources, including xenon arc solar simulators and fluorescent sources, informs our ability to accurately control these sources. We serve the... Show more »

Our scientists have pioneered the quantitative study of cutaneous photobiology by designing instruments, techniques and protocols now accepted as industry standards. Expert knowledge of light sources, including xenon arc solar simulators and fluorescent sources, informs our ability to accurately control these sources. We serve the pharmaceutical, chemical and agrochemical industries with in vivo and in vitro study designs that meet not only standard, but specialized requirements for evaluation of any test material.

Cytotoxicity endpoints in cell lines or hepatocytes
- In vitro 3T3 NRU phototoxicity assay (OECD 432; ICH S10)
- In vitro phototoxicity in the human reconstructed skin model Epiderm (ICH S10)
- Photo Ames assay
- Melanin Binding assay (ICH S10)
- In vitro drug screening, development and safety testing
- Regulatory experience in the phototoxicology field

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Infusion Toxicology
Price on request

Charles River has decades of experience in the conduct of safety and efficacy studies utilizing infusion dosing techniques essential for evaluating parenteral drug formulations. Our in-depth knowledge and skill of intermittent and continuous infusion studies for both rodent and nonrodent species can help support your research.... Show more »

Charles River has decades of experience in the conduct of safety and efficacy studies utilizing infusion dosing techniques essential for evaluating parenteral drug formulations. Our in-depth knowledge and skill of intermittent and continuous infusion studies for both rodent and nonrodent species can help support your research. Acute to chronic studies requiring infusions of minutes or hours to continuous (24-hour) infusion using indwelling or peripheral catheters can be performed, as appropriate.

To overcome the ever-increasing challenges posed by pharmaceutical and biopharmaceutical compounds, we are continually expanding our range of infusion toxicology services to meet the needs of this specialized route of administration. Procedures have been established to allow us to support the conduct of ICH-compliant reproductive and juvenile toxicology studies utilizing infusion techniques.

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Dermal Toxicology
Price on request

Our full dermal toxicology testing service is designed to cross all industrial sectors. Therapeutic indication and topical use are considered in the design of a dermal testing program. We offer a range of studies to include penetration, irritation, sensitization, wound healing and photobiology. In addition, access to advanced... Show more »

Our full dermal toxicology testing service is designed to cross all industrial sectors. Therapeutic indication and topical use are considered in the design of a dermal testing program. We offer a range of studies to include penetration, irritation, sensitization, wound healing and photobiology. In addition, access to advanced technology allows us to offer in vitro alternatives to traditional in vivo models for some forms of testing.

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Biocompatibility Testing
Price on request

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the... Show more »

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the effects of new orthobiologic applications. Non-GLP efficacy models are available for early research.

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Orthopedic Models
Price on request

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the... Show more »

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the effects of new orthobiologic applications. Non-GLP efficacy models are available for early research.

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Medical Device Testing
Price on request
Request a quote for more information about this service.
DART Studies
Developmental and Reproductive Toxicology Studies
Price on request

Charles River offers overall developmental and reproductive toxicology (DART) program planning and individual study design to conduct safety assessments for your products according to internationally recognized guidelines, including ICH and OECD.

We conduct male and female fertility, developmental toxicity (embryo-fetal... Show more »

Charles River offers overall developmental and reproductive toxicology (DART) program planning and individual study design to conduct safety assessments for your products according to internationally recognized guidelines, including ICH and OECD.

We conduct male and female fertility, developmental toxicity (embryo-fetal development), pre- and postnatal development and multigenerational studies to assess the potential effects of novel products on the entire reproductive spectrum. Our expertise includes pharmaceuticals (including vaccines, biopharmaceuticals, and veterinary and medical devices) agrochemicals, industrial chemicals and food additives. Our multigenerational study portfolio now includes the Extended One-Generation Reproductive Toxicity Study, required to satisfy OECD Guideline 443.

A full range of rodent and nonrodent species are tested with dose routes ranging from dermal to intravenous infusion. A range of specialized functional evaluations is also available, including neurobehavioral testing and immunologic assays. All studies are supported by our own laboratory and regulatory experts.

  • Developmental and reproductive pathology
  • Specialized neurobehavioral testing
  • Functional assessments, including growth (and the skeleton), pulmonary, neurobehavioral, reproductive and immunological development
  • Toxicokinetic evaluations, including induction studies
  • Juvenile toxicity testing in rodents and nonrodent species
  • Screening Information Data Sets (SIDS)

Specialized evaluations:
- Hormone assays
- Male reproductive assessments in rodents and nonrodents
- Variety of behavioral tests (e.g., activity and learning and memory) for pre- and postnatal and multigenerational studies
- Range of developmental immunology tests that can be added to pre- and postnatal and multigenerational studies
- Endocrine disruptor screenings (in vivo and in vitro)
- Skeletal measurements (e.g., bone size, geometry and density) for pre- and postnatal studies using micro-CT, pQCT, X-ray and DXA

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Safety Pharmacology
Price on request

Making decisions about your safety pharmacology study can be challenging. We can help. Charles River has established ICH core battery tests and supplementary models to meet current regulatory requirements and provide meaningful data. We can customize your study to address both your program- and compound-specific needs, or include... Show more »

Making decisions about your safety pharmacology study can be challenging. We can help. Charles River has established ICH core battery tests and supplementary models to meet current regulatory requirements and provide meaningful data. We can customize your study to address both your program- and compound-specific needs, or include our core safety parameters in toxicology studies as an efficient means of meeting regulatory expectations.

Our safety pharmacology facilities feature dedicated telemetry suites, surgical pharmacology capabilities and custom-built cardiovascular laboratories that allow for remote observation of the animals without disrupting data collection.

We have validated the use of electrocardiogram (ECG) pattern recognition software to increase the sensitivity of our ECG analyses, and have integrated automated arrhythmia detection for full ECG data sets.

The core battery of safety pharmacology studies should be included in small molecule IND-enabling programs to assess the acute and potentially life-threatening risks of novel pharmaceuticals for human use.

  • Cardiovascular System: Blood pressure, heart rate, electrocardiograms (ECGs), left ventricular pressure, echocardiography
  • Respiratory System: Respiratory rate, hemoglobin oxygen saturation, tidal and minute volumes
  • Central Nervous System (CNS): Functional observation battery (FOB), modified Irwin screen, body temperature, large animal neurological evaluations
  • In Vitro Electrophysiology: Cloned human potassium channels (hERG)

Second-tier studies can be used to develop a greater understanding of mechanistic effects on vital functions, and evaluate potential adverse effects on other organ systems such as renal and gastrointestinal systems.

  • Tier II Assessments: Cardiovascular system, central nervous system (CNS) and respiratory system assessments
  • Renal/Urinary: Renal function and general clinical chemistry
  • Gastrointestinal: Motility and function
  • In Vitro Electrophysiology: Anticipated CiPA battery
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Inhalation Toxicology
Price on request

With decades of experience, Charles River offers a full range of inhalation toxicology study designs to support the worldwide registration of pharmaceuticals, agrochemicals and chemicals. Our expert toxicologists work within our modern inhalation laboratory facilities, which are equipped with custom-designed apparatus for a... Show more »

With decades of experience, Charles River offers a full range of inhalation toxicology study designs to support the worldwide registration of pharmaceuticals, agrochemicals and chemicals. Our expert toxicologists work within our modern inhalation laboratory facilities, which are equipped with custom-designed apparatus for a variety of inhalation toxicology studies in multiple species.

Our experience includes specialized studies to demonstrate efficacy or pharmacotoxicity, the selection of inhaled drug formulations and inhalation delivery systems, design of appropriate analytical methodologies and the estimation of dosage in animal models.

Study Types
- Reproductive inhalation
- Immunologic sensitization via inhalation
- Intranasal
- Intratracheal
- Anti-asthmatic efficacy
- Neonatal inhalation
- Acute to chronic toxicity, plus carcinogenicity
- Nose-only, oronasal and head-only
- Radiolabeled aerosol studies

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Respiratory Diseases
Ocular Toxicology
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Our ocular specialists perform safety and efficacy studies using intravitreal injection, topical instillation, subretinal dosing and other systemic routes of exposure. Programs are designed for therapeutic agents targeting a range of diseases and conditions, such as age-related macular degeneration, diabetic retinopathy, glaucoma... Show more »

Our ocular specialists perform safety and efficacy studies using intravitreal injection, topical instillation, subretinal dosing and other systemic routes of exposure. Programs are designed for therapeutic agents targeting a range of diseases and conditions, such as age-related macular degeneration, diabetic retinopathy, glaucoma and cytomegalovirus. In addition, we can perform in vitro eye irritation testing and can confirm negative tests in vivo.

Support Services:
- Specular microscopy for noninvasive, in vivo evaluation of the corneal endothelium
- Electroretinography
- Spectral domain optical coherence tomography (SD-OCT, anterior and posterior)
- Tonometry (IOP) evaluations
- Pachymetry (corneal thickness)
- Digital fundus photography/video
- Confocal scanning laser ophthalmoscope (multiple image modes - infrared and tomography for 3D images)
- Fundus autofluorescence
- Fluorescein angiography (FA) and Indocyanine green angiography (ICG)
- Vitrectomy
- Quantitative autoradiography
- Ocular and systemic tissue distribution
- Enhanced microscopic evaluation
- Ocular surgery/implant

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Genotoxicity Testing
Price on request

For more than 30 years, Charles River has been helping clients develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs as part of a comprehensive safety assessment program or as a stand-alone service.
With three sites in North America and Europe and a team of... Show more »

For more than 30 years, Charles River has been helping clients develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs as part of a comprehensive safety assessment program or as a stand-alone service.
With three sites in North America and Europe and a team of more than 70 scientists and support staff, we take an active role in the development of the assays and have in-depth experience complying with global regulatory guidelines and guidance (FDA, EPA, OECD, ICH, EMEA, Health Canada, etc.) in testing a wide variety of compounds, including but not limited to pharmaceuticals, biologicals, medical devices, industrial chemicals, agrochemicals, nutraceuticals, food additives, cosmetics and petroleum products.

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In vivo Immunotoxicity Testing
Price on request

Regulatory guidelines recommend incorporation of immunotoxicity assessments within preclinical and clinical studies. Charles River conducts immunotoxicity assessments in relevant animal models, either as part of a toxicology study or as a stand-alone service. We offer a complete panel of GLP-validated immunotoxicology assays,... Show more »

Regulatory guidelines recommend incorporation of immunotoxicity assessments within preclinical and clinical studies. Charles River conducts immunotoxicity assessments in relevant animal models, either as part of a toxicology study or as a stand-alone service. We offer a complete panel of GLP-validated immunotoxicology assays, including development, validation and sample analysis for antidrug antibodies as part of preclinical and clinical safety assessments of peptide and protein therapeutics.

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In vivo Phototoxicity Testing
Price on request

Our scientists have pioneered the quantitative study of cutaneous photobiology by designing instruments, techniques and protocols now accepted as industry standards. Expert knowledge of light sources, including xenon arc solar simulators and fluorescent sources, informs our ability to accurately control these sources. We serve the... Show more »

Our scientists have pioneered the quantitative study of cutaneous photobiology by designing instruments, techniques and protocols now accepted as industry standards. Expert knowledge of light sources, including xenon arc solar simulators and fluorescent sources, informs our ability to accurately control these sources. We serve the pharmaceutical, chemical and agrochemical industries with in vivo and in vitro study designs that meet not only standard, but specialized requirements for evaluation of any test material.

Qualitative and quantitative phototoxicology in mice, rats and guinea pigs
- Photoallergy studies, including photoactivated sensitizers
- Safety assessment of photodynamic drugs
- Safety assessment of unique light sources
- Expertise in ocular phototoxicity in rats and rabbits
- Board-certified veterinary ophthalmologists
- Experienced ophthalmic pathologists
- Light exposure (UVR, visible, near-infrared) under surgical conditions
- Assessment of potential damage to thoracic and abdominal organs

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In Vitro Skin Corrosion Test
Price on request

Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River.

Skin Corrosion Assays:
SkinEthic EpiSkin® skin... Show more »

Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River.

Skin Corrosion Assays:
SkinEthic EpiSkin® skin corrosion (OECD 431)
Corrositex® skin corrosion (OECD 435)
Acute dermal rodent

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Veterinary Molecular Diagnostics
Price on request

Charles River offers molecular pathology services that include in situ hybridization (ISH), real-time PCR (rt-PCR) and quantitative PCR (qPCR), performed by a staff with a strong background in molecular biology and histopathology. This integration means we can relate gene expression to tissue histomorphology in both normal tissues... Show more »

Charles River offers molecular pathology services that include in situ hybridization (ISH), real-time PCR (rt-PCR) and quantitative PCR (qPCR), performed by a staff with a strong background in molecular biology and histopathology. This integration means we can relate gene expression to tissue histomorphology in both normal tissues and therapeutic models of disease, providing valuable functional genomics information. The end result is the best possible interpretation and troubleshooting of molecular-based tools applied to toxicological pathology issues.

  • Procurement, embedding and sectioning of study tissues
  • Synthesis of DNA and RNA probes (isotopic and non-isotopic)
  • Optimized hybridization
  • Histological evaluation by board-certified pathologists
  • Reporting with representative color photomicrographs
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Human Biobanking
Price on request

Research records and materials are vital to your drug development program. It is fundamental that they be properly stored in an GxP compliant archive facility that enables reliable and rapid retrieval.
Our facilities and services provide short- and long-term GxP-compliant data and sample archiving services in support of... Show more »

Research records and materials are vital to your drug development program. It is fundamental that they be properly stored in an GxP compliant archive facility that enables reliable and rapid retrieval.
Our facilities and services provide short- and long-term GxP-compliant data and sample archiving services in support of preclinical and clinical studies for government and private sector businesses, organizations and consortia.
By archiving with Charles River you get:
- Expedited retrieval of records for agency/client inspections
- Site visits and on-site access to Study Directors
- Full service record keeping from inception to destruction

Facilities and Services:
- Over 500,000 cubic feet of controlled, dedicated space
- Several layers of security to limit access as well as safeguard essential study materials under GLP conditions
- Storage conditions include room temperature, refrigerated, frozen at -20°C or -70°C and cryostorage at -196°C
- Periodic inventory and materials inspections
- Hard copy transfer to CD
- Microform printing
- Pick-up and delivery services for both short-term and long-term storage

Specimens/Materials:
- Paper data, records and reports
- Electronic media
- Microform
- Pathology samples (e.g., wet tissues, frozen tissues, paraffin and plastic blocks)
- Microslides
- Test articles
- Medical records
- Vaccines
- Biological samples
- Radioactive material

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Histology and Pathology Services
Price on request

In addition to standard hematoxylin and eosin (H&E) histology, we perform a wide variety of special stains and techniques, including immunohistochemistry and in situ hybridization. Stains are available for localization of carbohydrates, nucleic acids, polysaccharides, proteins, lipids, enzymes, mRNA and cellular structures.... Show more »

In addition to standard hematoxylin and eosin (H&E) histology, we perform a wide variety of special stains and techniques, including immunohistochemistry and in situ hybridization. Stains are available for localization of carbohydrates, nucleic acids, polysaccharides, proteins, lipids, enzymes, mRNA and cellular structures. Other capabilities include:
- Specialized histochemical stains for specific cellular components
- Plastic processing (GMA) for producing thin sections in support of reproductive pathology and neuropathology
- Plastic embedding (MMA) for microtomy of hard tissues and devices and peripheral nerves (Spurr’s resin)
- Frozen tissue processing and sectioning

Our specialty pathology services include:
- Evaluation of acute, subchronic, chronic/oncogenicity, developmental and reproduction studies
- Immunopathology
- Renal pathology
- Reproductive pathology
- Respiratory pathology
- Hepatobiliary pathology
- Juvenile pathology
- Carcinogenesis studies
- Morphometric/Stereological analysis
- Cell proliferation assays (BrdU Ki67 and PCNA)

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Project Management, Consulting, & Support Services
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Data Services
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Animal Models and Studies
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Oncology Animal Models
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Oncology Animal Models Services

Oncology Animal Models Services

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Microscopy
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Protein Expression Visualization
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Clinical Research
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Computational Modeling
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Animal Models of Disease
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Protein Services
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Biology
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Immunostaining
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Cells and Tissues
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Biospecimens
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Imaging & Spectroscopy
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Genetic Engineering
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Regulatory Affairs Services
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In vitro Disease Models
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In vitro Disease Models Services

In vitro Disease Models Services

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Biospecimen Management and Storage
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Formulation Services
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In vitro Toxicity Testing
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Functional Human Tissue Assays
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Clinical Laboratory Services
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Bone/Cartilage Animal Models
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DNA
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Pharmacology & Toxicology
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Clinical and Anatomic Pathology
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Safety Pharmacology & Efficacy Testing
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In vitro ADME
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In vitro ADME Services

In vitro ADME Services

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IND/NDA/BLA Submission
Investigational New Drug/New Drug Application Submission
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Antibody Services
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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Manufacturing Services
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Drug Discovery & Development
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Drug Discovery & Development Services

Drug Discovery & Development Services

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Environmental Studies
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Biochemistry & Molecular Biology
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Geological Sciences
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Veterinary Laboratory Services
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Veterinary Research & Diagnostic Services
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Nucleic Acid Services
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Medical Devices & Diagnostics
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DNA Hybridization
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