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Toxikon Corporation

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Bedford, Massachusetts, US

About Toxikon Corporation

Toxikon is a leading preclinical contract research organization (CRO) providing in vivo, in vitro, and analytical testing services for the pharmaceutical, biotechnology, and medical device industries – helping those companies gain approval for their products quickly and bring them to market successfully.

We... Show more »

Toxikon is a leading preclinical contract research organization (CRO) providing in vivo, in vitro, and analytical testing services for the pharmaceutical, biotechnology, and medical device industries – helping those companies gain approval for their products quickly and bring them to market successfully.

We are proud to play a vital and singular role in the chain of events that move innovative therapies from concept, through research and development, into trials and approvals, through production and commercialization, and finally delivered to the consumer. We care about your products – and the life-changing outcomes they can offer – as much as you do.

With over 40 years of broad and deep experience in navigating the dynamic regulatory landscape, we have the expertise and technical skill to supply you with the results you need to gain approval for your products, demonstrating safety and efficacy.

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Certifications & Qualifications

AAALAC FDA Inspected GLP IACUC ISO 17025 USDA

Diversity Certificates

Minority owned business Small business

Our Services (112)


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Medical Device Testing

Price on request

Toxikon provides full testing support for the ISO 10993 guidance.

With a strong foundation in toxicology and biocompatibility, our custom device testing capabilities include:
* ocular device and drug product development
* proof of concept studies
* surgical efficacy studies
* comprehensive biocompatibility analysis
*... Show more »

Toxikon provides full testing support for the ISO 10993 guidance.

With a strong foundation in toxicology and biocompatibility, our custom device testing capabilities include:
* ocular device and drug product development
* proof of concept studies
* surgical efficacy studies
* comprehensive biocompatibility analysis
* sterilization support
* reusable medical device cleaning validation
* combination product evaluations

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ISO 10993

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Custom Ophthalmology Animal Models

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As a multidisciplinary contract research organization, Toxikon is focused on evaluating the safety and toxicity of biologics, pharmaceuticals and medical devices. One of Toxikon’s specialties is conducting studies focused on the treatment of ocular diseases. Our experienced study directors will provide you with the expertise in... Show more »

As a multidisciplinary contract research organization, Toxikon is focused on evaluating the safety and toxicity of biologics, pharmaceuticals and medical devices. One of Toxikon’s specialties is conducting studies focused on the treatment of ocular diseases. Our experienced study directors will provide you with the expertise in ophthalmology models and endpoints for your ocular drug program.

Ophthalmic Development Capabilities:

While our reputation has been built on our vast toxicology and chemistry experience,Toxikon’s Ocular Program capabilities include:

  • Intra-vitreal injections, stereotaxic surgery
  • Aesthesiometry, tonometry, pupilometry; and electroretinography (ERG)
  • Slit-Lamp exams and Draize and McDonald-Shadduck scoring systems Direct and indirect ophthalmoscopy
  • Anterior/posterior segment and fundus photography
  • Ocular tissue dissection, distribution and PK/PD/ADME
  • Retina/choroid flat-whole mounting, confocal microscopy, and RGC quantitation
  • Ocular histology/pathology and clinical support
  • Stereo and fluorescent microscopy
  • Optic nerve damage assessment
  • Specialized surgeries (e.g. episcleral vein injections to induce elevated IOP)

These studies in small and large animal models, include acute irritation, ocular distribution (PK/PD), acute and repeat dose toxicity, implantation, drug screening and drug efficacy. We can also customize studies for targeted therapeutics, such as dry eye and corneal wound healing, inflammation and uveitis, neovascularization and age-related macular degeneration, glaucoma and neuroprotection.

As part of our extensive custom research and testing portfolio for ophthalmic drug discovery, we offer a variety of preclinical services, including the screening of neuroprotective compounds and creation of animal models for glaucoma research. Our scientists are experts in the field, and their work is published widely. We invite you to speak with them at upcoming conferences and to see samples of their work.

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In vivo Bioavailability/Bioequivalence Studies

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In vivo Pharmacology Studies

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Toxicology

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USP Water Testing

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UV-VIS Spectroscopy

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Trace Metal Analysis

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Sterility Testing

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Chemical Stability Testing

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Product Stability Testing

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Raw Material Testing

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In vivo Drug Efficacy Testing

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Photostability Studies

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Preclinical Study Design

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Biocompatibility Testing

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The goal of in vivo testing medical devices is to determine the safety or biocompatibility of the device in a biological environment. Toxikon can design a study that is specific to determining the ability of a medical device to perform with an appropriate host response in a given application. Our In Vivo Department study... Show more »

The goal of in vivo testing medical devices is to determine the safety or biocompatibility of the device in a biological environment. Toxikon can design a study that is specific to determining the ability of a medical device to perform with an appropriate host response in a given application. Our In Vivo Department study directors will work closely with you to design biocompatibility assessments to measure the magnitude and duration of alterations in homeostatic mechanisms, favorable and adverse, in determining host response.

Some of the services for medical device development that Toxikon offers are:

  • Biocompatibility
  • Analytical and Bioanalytical Chemistry
  • Microbiology
  • Chronic, Genetic and Molecular Toxicology
  • Reproductive and Developmental Toxicology

Other tests: Sensitization, intracutaneous irritation, acute systemic toxicity, subchronic toxicity, implantation, hemocompatibility, and carcinogenicity.

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Radiotracers and Radiopharmaceuticals

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Microbiology Testing

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In vitro Metabolic Stability Assays

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Material Testing Services

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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
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Mass Spectrometry

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HPLC

High Performance Liquid Chromatography
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In vivo Immunotoxicity Testing

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Immunobiology Services

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Pharmaceutical Formulation

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Extractable and Leachable Testing

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Drug Development

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Contract Research

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Package and Container Testing

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Gas Chromatography (GC)

Gas Chromatography
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Chemical Analysis

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Biological Testing

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Bioanalytical Analysis LC/MS/MS

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Analytical Validation

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Analytical Method Development

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Analytical Chemistry Services

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Accelerated Stability Testing

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Mutagenicity Testing

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Maximum Tolerated Dose (MTD) Studies

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Impurity Analysis

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Animal Surgery

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AH50 Assay

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CH50 Assay

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In vitro Hemolysis Assay

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Antimicrobial Efficacy Testing

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Agar Diffusion Testing

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Guinea Pig Models

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Athymic Nude-Foxn1nu Mouse Model

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A/J Mouse Model

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Rabbit Models

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Compendial Testing

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Ocular Inflammation Animal Models

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  • Experience performing both short term and long term ocular studies
  • Studies typically cover conjunctiva, cornea, lens, fundus, choroid, and optic nerve
  • Studies performed by in-house ophthalmologist with experience performing ocular implants

  • Ocular Examinations include:
    •Anterior segment of the eye•Slit-Lamp; Draizeand... Show more »

  • Experience performing both short term and long term ocular studies
  • Studies typically cover conjunctiva, cornea, lens, fundus, choroid, and optic nerve
  • Studies performed by in-house ophthalmologist with experience performing ocular implants

  • Ocular Examinations include:
    •Anterior segment of the eye•Slit-Lamp; Draizeand McDonald-Shadduckscoring systems
    •Posterior segment of eye
    •Direct & Indirect ophthalmoscopy

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Glaucoma Animal Models

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Corneal Dystrophy Animal Models

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Dry Eye Animal Models

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Macular Degeneration Animal Models

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Diabetic Retinopathy Animal Models

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In vivo Protein Binding Assays

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Microbiology Assays

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Cells and Tissues

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Chromatography

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In vitro Bioavailability/Bioequivalence Studies

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Spectroscopy

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Biospecimens

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Water Quality Monitoring

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Process Consulting

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In vivo Toxicity Testing

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Clinical Immunology Tests

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Safety Pharmacology

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Biomolecular Interaction Analysis

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In vitro Disease Models

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Model Organisms

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Product Testing Services

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In vivo PK/PD Studies

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Medical Imaging Services

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Animal Models and Studies

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Mouse Models

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Liquid Chromatography (LC)

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Clinical Research

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Sample Analysis

Sample Analysis

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Chemistry and Materials

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Clinical Laboratory Services

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Product Development, Testing, and Packaging

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Biocompatibility testing of materials and packaging.

Biocompatibility testing of materials and packaging.

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Microbiology

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Cytotoxicity Assays

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Animal Models of Disease

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Packaging Services

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Radiochemistry

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Immunoassays

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In vitro ADME/DMPK Studies

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Spectrophotometry

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Cell Culture Media and Reagents

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Rodent Models

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Bioanalysis

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Antimicrobial Activity Testing

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Formulation Services

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Imaging & Spectroscopy

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Medical Devices & Diagnostics

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Drug Discovery & Development

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Biology

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Ophthalmology Animal Models

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Bioanalytical Assays

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Project Management

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Regulatory Affairs Services

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Animal Physiology Analyses

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Pharmacology & Toxicology

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Mammalian Models

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Toxicity Animal Model

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Biochemistry & Molecular Biology

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Assay Development

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Pharmacology

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Pharmacology Services

Pharmacology Services

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Branden Morris

Director of Marketing

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