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MPI Research - Drug Safety Evaluation

Mattawan, MI, US

MPI Research is a full drug development contract research organization with the world’s largest single-site preclinical facility. Our Sponsors benefit from our full suite of preclinical research services.

Our Sponsors value our collaborative culture that is uniformly committed to helping them move their compounds from bench to regulatory filing with accuracy, quality, and speed. Our experienced staff is flexible in adapting to changes and quickly responds to challenges as they arise.

MPI Research insists on the highest quality professional standards across all services and at all levels, and is in full compliance with international, federal, and state regulatory agencies. We are

  • Fully AAALAC accredited
  • In compliance with all FDA, EPA, EMEA, OECD, ICH, and JMHW guidances and regulations
  • Dedicated to quality performance and continuous improvement, with registered QA professionals (RQAP-GLP) and on-staff... Show more »

MPI Research is a full drug development contract research organization with the world’s largest single-site preclinical facility. Our Sponsors benefit from our full suite of preclinical research services.

Our Sponsors value our collaborative culture that is uniformly committed to helping them move their compounds from bench to regulatory filing with accuracy, quality, and speed. Our experienced staff is flexible in adapting to changes and quickly responds to challenges as they arise.

MPI Research insists on the highest quality professional standards across all services and at all levels, and is in full compliance with international, federal, and state regulatory agencies. We are

  • Fully AAALAC accredited
  • In compliance with all FDA, EPA, EMEA, OECD, ICH, and JMHW guidances and regulations
  • Dedicated to quality performance and continuous improvement, with registered QA professionals (RQAP-GLP) and on-staff Lean Six Sigma Blackbelts
  • Continually conducting inspections of GLP and Bioequivalence studies and reports
  • Committed to conducting ongoing operational and subcontractor audits

In the field of Drug Safety MPI Research offers expert services in the following areas:

Developmental and Reproductive Toxicology

Understanding a compound’s effect on a mature organism is an essential step in drug development—but hardly the only one. Equally compelling is the need to know how a drug candidate affects reproductive and developmental functions, from fertility to embryonic, prenatal and postnatal development, as well as maternal and juvenile effects. Developmental and reproductive toxicology (DART) testing of chemicals and pesticides, small-molecules, and biologics must be vigorous, comprehensive, and reliable.

Drug Metabolism and Pharmacokinetics Research

Attrition rates during clinical development of new therapeutics are as high as 95%—disturbing news for both patients and drug developers. In addition to failure from efficacy and safety concerns, clinical failures can also be attributed to poor pharmacokinetic (PK) properties. Providing early critical drug metabolism and pharmacokinetic (DMPK) information is the secret to addressing DMPK failures. Companies with solid DMPK drug development programs have been able to cut clinical failures that are due to DMPK reasons from 40 percent to 10 percent, a four-fold decrease. MPI Research has the expertise and experience to ensure that your studies are conducted quickly and
successfully. MPI Research is committed to helping our Sponsors achieve the best possible clinical success rates.

General Toxicology

Regulatory agencies require that Sponsors understand the potential risks for their products; much of that information comes from general toxicology studies. The foundational role of toxicology is to define the effects of a substance on a living organism, including symptoms and mechanisms of action. As the breadth of compounds in development grows more diverse, toxicology studies are becoming increasingly complex.

Infusion Toxicology

The curve of advancements in infusion technology is progressing and rapidly advancing new equipment, more routes of administration, targeted tissue dosing, and increasingly complex routines. With greater capabilities come bigger demands for relevant knowledge and proficiency. Skillfully applying advanced technologies, customized studies, and exceeding expectations in quality, speed, accuracy, and cost-effectiveness, MPI Research offers the competitive edge that Sponsors need.

Nonclinical Dose Formulation and Analysis

Optimizing drug exposure is a crucial element in assessing drug safety and requires careful choice of formulation. Even with an appropriate formulation, determining the appropriate dosing levels requires careful consideration. This is no small consideration; the benefit of any medication, defined by its pharmacokinetic and pharmacodynamics profile is affected tremendously by how it is made and administered. Careful, precise analysis of test formulations assures proper dosing and accurate interpretation of the effect of the drug on the test system.

Safety Pharmacology

Developing a predictive understanding of a medication safety profile is more important than ever. As part of this endeavor, modern safety pharmacology studies must be designed to precisely characterize potential functional liabilities, ideally determining dose-response relationships including onset, peak response, resolution of effect, and mechanism(s) of action and/or potential reversibility. Translating data from key preclinical safety pharmacology studies to human clinical trials and beyond represents a complex enterprise that must be expertly conducted to ensure progression of therapeutic, palatable, and safe drug candidates.

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MPI Research - Drug Safety Evaluation has not listed any services.

Pulmonary Hypertension Animal Models
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In vitro ADME
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  • In vivo studies with or without mass-balance
    • Pharmacokinetics
    • Tissue distribution
    • Rates and routes of excretion
    • Biliary excretion hepatobiliary recirculation
    • Animals (rodents, dogs, and nonhuman primates) surgically prepared for vascular access and bile collection
  • Biodistribution modalities
    -... Show more »
  • In vivo studies with or without mass-balance
    • Pharmacokinetics
    • Tissue distribution
    • Rates and routes of excretion
    • Biliary excretion hepatobiliary recirculation
    • Animals (rodents, dogs, and nonhuman primates) surgically prepared for vascular access and bile collection
  • Biodistribution modalities
    • Traditional dissection and analysis
    • Quantitative Whole-Body Autoradiography (QWBA), traditional two-dimensional and three-dimensional
    • Positron Emission Tomography (PET)
    • Single Photon Emission Tomography (SPECT)
  • Metabolite identification
    • Radiochromatographic profiling and UV or MS metabolite profiling
    • High Performance Liquid Chromatography (HPLC) with UV and flow-through radioactivity detection
    • Structure elucidation of major metabolites
    • Thermo LTQ Orbitrap Discovery™ high-resolution and API 5000 tandem mass spectrometers (MS)
  • In vitro metabolism
    • Protein binding
    • Metabolite profile and metabolite ID
      • Enzymes, cell fractions (microsomes), cells (hepatocytes),tissues, and in situ preparations
    • Reactive metabolites
    • Stability in microsomes, S9 fraction, and/or hepatocytes
    • Plasma/whole blood partitioning
    • Elucidation of metabolic pathways
    • Drug-drug interaction (DDI) studies (if needed)
      • CYP activity profiles, CYP inhibition and induction
    • Permeability and drug transport
      (influx and efflux)
  • Specialty studies
    • Dermal penetration in swine and nonhuman primate
    • Melanin binding determination in Long-Evans rats and Dutch- Belted rabbits
    • Full ocular tissue distribution determination by dissection in rats, rabbits, canines, and nonhuman primates
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Dosage Form Development
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MPI Research embraces a philosophy of collaboration. For us, “collaboration” is more than a buzzword; it is the foundation of success in contemporary drug development. We bring exceptional analytical skills to the process of understanding drug formulation and its impact on the effectiveness of promising new medications. We engage... Show more »

MPI Research embraces a philosophy of collaboration. For us, “collaboration” is more than a buzzword; it is the foundation of success in contemporary drug development. We bring exceptional analytical skills to the process of understanding drug formulation and its impact on the effectiveness of promising new medications. We engage Sponsors as partners in the process, determined to exceed their expectations with high- quality results.
MPI Research helps Sponsors take that next step with confidence. We offer an extensive menu of tailored, systematic methodologies to determine the right dose formulation strategy. The pharmacokinetic and pharmacodynamic impact of formulation design requires accurate analysis and consistent, validated production of test compound formulations. We are committed to applying our expertise to assist Sponsors in method development, validation, scale-up, and manufacturing at preclinical, clinical, and commercial quantities.

Service Highlights

  • Diverse analytical platforms including Waters Alliance and Agilent 1200 High Performance Liquid Chromatography (HPLC) systems with photodiode array, refractive index, fluorescence, and Mass Spectrometric (MS and MS/MS) detection
  • Agilent 6890 gas chromatographs with flame ionization, electron capture, and mass spectrometric detection
  • Various platforms to analyze proteins and peptides including
    • HPLC (reversed phase, SEC, and affinity)
    • Total protein assays (Ultra Violet [UV] spectrophotometric and colorimetric assays)
  • Experience with various vehicle types such as solutions, suspensions, creams, oils, and dietary ad-mixtures
  • Flexible scheduling with excess capacity to accommodate last-minute requests, changes in timelines, and rapid study starts
  • Systematic approach to method development and validation that results in analytical methods being available for routine analysis of formulated materials before dosing
  • Start-to-finish collaboration with our colleagues in drug safety, as we execute all aspects of general toxicology, safety pharmacology, and development and reproductive toxicology
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Agilent 1200 HPLC
In vivo PK/PD Studies
Price on request
  • In vivo studies with or without mass-balance
    • Pharmacokinetics
    • Tissue distribution
    • Rates and routes of excretion
    • Biliary excretion hepatobiliary recirculation
    • Animals (rodents, dogs, and nonhuman primates) surgically prepared for vascular access and bile collection
  • Biodistribution modalities
    -... Show more »
  • In vivo studies with or without mass-balance
    • Pharmacokinetics
    • Tissue distribution
    • Rates and routes of excretion
    • Biliary excretion hepatobiliary recirculation
    • Animals (rodents, dogs, and nonhuman primates) surgically prepared for vascular access and bile collection
  • Biodistribution modalities
    • Traditional dissection and analysis
    • Quantitative Whole-Body Autoradiography (QWBA), traditional two-dimensional and three-dimensional
    • Positron Emission Tomography (PET)
    • Single Photon Emission Tomography (SPECT)
  • Metabolite identification
    • Radiochromatographic profiling and UV or MS metabolite profiling
    • High Performance Liquid Chromatography (HPLC) with UV and flow-through radioactivity detection
    • Structure elucidation of major metabolites
    • Thermo LTQ Orbitrap Discovery™ high-resolution and API 5000 tandem mass spectrometers (MS)
  • In vitro metabolism
    • Protein binding
    • Metabolite profile and metabolite ID
      • Enzymes, cell fractions (microsomes), cells (hepatocytes),tissues, and in situ preparations
    • Reactive metabolites
    • Stability in microsomes, S9 fraction, and/or hepatocytes
    • Plasma/whole blood partitioning
    • Elucidation of metabolic pathways
    • Drug-drug interaction (DDI) studies (if needed)
      • CYP activity profiles, CYP inhibition and induction
    • Permeability and drug transport
      (influx and efflux)
  • Specialty studies
    • Dermal penetration in swine and nonhuman primate
    • Melanin binding determination in Long-Evans rats and Dutch- Belted rabbits
    • Full ocular tissue distribution determination by dissection in rats, rabbits, canines, and nonhuman primates
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Preclinical PK/PD Studies
in vivo Pharmacokinetics/Pharmacodynamics
Price on request

In vivo studies offer

  • Pharmacokinetics (dose-to-data in 72 hours)
  • Screening of multiple compounds
  • Dose range finding (DRF) and maximum tolerated dose (MTD)
  • Lead optimization
  • Bioequivalence
  • Modeling services using Phoenix WinNonlin®

In vivo studies offer

  • Pharmacokinetics (dose-to-data in 72 hours)
  • Screening of multiple compounds
  • Dose range finding (DRF) and maximum tolerated dose (MTD)
  • Lead optimization
  • Bioequivalence
  • Modeling services using Phoenix WinNonlin®
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DART Studies
Developmental and Reproductive Toxicology Studies
Price on request

Conducting quality DART studies on a vast array of compounds from many different industries is proof-positive
of the collaborative expertise at MPI Research. By employing the best and brightest from private and public sectors, we enhance our collective skillset while speaking the language of our Sponsors. We understand their... Show more »

Conducting quality DART studies on a vast array of compounds from many different industries is proof-positive
of the collaborative expertise at MPI Research. By employing the best and brightest from private and public sectors, we enhance our collective skillset while speaking the language of our Sponsors. We understand their needs, and we dedicate ourselves to meeting them.

MPI Research offers industry-leading study designs, with DART expertise set firmly on the competitive edge. These designs are customized to individual Sponsor needs aligned with regulatory guidances, including FDA, EMEA, and OECD standards. Our capabilities encompass a variety of species and routes of administration, all aimed at determining the safety and biological effects of compounds.

Service Highlights

  • Fertility and early embryonic development studies (rodent)
  • Pre- and postnatal development studies, including maternal function (rodent)
  • Embryo-fetal development studies (rodent, rabbit)
  • Neonatal and juvenile animal studies
  • Developmental neurotoxicology studies
  • Toxicokinetic evaluation
  • Maternal evaluations
    • Necropsy
    • C-sections
    • Uterine examinations
  • Post-life fetal evaluations in multiple species and strains
    • External morphology
    • Visceral
    • Skeletal
  • Neurobehavioral assessments
    • Motor activity
    • Learning
    • Memory
    • Acoustic startle response
  • Sperm assessments
    • Concentration
    • Count
    • Motility (using Hamilton Thorne IVOS Analyzer)
    • Morphology
  • A complete suite of developmental and fertility studies in cynomolgus monkeys with all necessary endpoints, including
    • Monitoring of menstrual and mating cycles
    • Dosing and handling of pregnant females
    • Use of ultrasound in determining pregnancy status and collecting key measurements such as fetal Heart Rate [HR], Crown-Rump Length [CRL], Bi-Parietal Diameter [BPD], Femur Length [FL], and other important aspects of fetal evaluation
    • C-section
    • Sperm collection and evaluation
    • Testes volume measurement
    • Blood collection to determine hormone and test article concentration
  • In vivo specialty studies for endocrine- disrupting chemicals
    • Uterotrophic
    • Hershberger assays
    • Male and female pubertal assays
  • Technical staff proficient in test
    article administration
    • Oral gavage
    • Dietary
    • Dermal
    • Subcutaneous (including implants)
    • Intravenous
    • Intramuscular
    • Intraperitoneal
    • Intravaginal
    • Intranasal
    • Infusion
  • Infant formula testing (piglet model)
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Bioequivalence Studies
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CYP Induction Assay
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CYP Inhibition Assay
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In vitro Metabolic Stability Assays
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MS-MS
Tandem Mass Spectrometry
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Fluorescence-Based Microscopy
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HPLC
High Performance Liquid Chromatography
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Custom Cardiovascular Animal Models
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Animal Plethysmography
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In vivo Efficacy Testing
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Animal Telemetry
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hERG Channel Inhibition Assay
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In vivo Cardiotoxicity Screening
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Small Animal Toxicology Studies
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Predictive toxicology
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Startle Response Test
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Cognition and Behavior Animal Models
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Animal Behavior Studies
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Animal Motor Function and Activity Testing
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PK/PD/TK Data Analysis
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Safety Pharmacology
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Raising the bar on the performance of safety pharmacology is another way MPI Research continues to advance its commitment to serving Sponsors. Accurate, meaningful, and timely study results that clearly demonstrate the functional safety profile of a drug candidate are essential. As partners with our Sponsors, we are focused on... Show more »

Raising the bar on the performance of safety pharmacology is another way MPI Research continues to advance its commitment to serving Sponsors. Accurate, meaningful, and timely study results that clearly demonstrate the functional safety profile of a drug candidate are essential. As partners with our Sponsors, we are focused on delivering high-quality, timely, and relevant data that facilitate development decisions. Effective collaboration is
a powerful contribution to the success of our Sponsors as we assist them in moving their compound to the
next phase.

The safety pharmacologists of MPI Research continually strive to adopt and develop the emerging technologies and essential skills that will drive enhanced insight. We facilitate overall program development by employing study designs appropriate to defining pharmacology, with consideration to the individual circumstances of each drug candidate. Our professional approach is collaborative and individualized, likewise focusing on the unique needs of each Sponsor.

Services Highlights

  • Fully GLP-compliant abuse and dependence liability assay in rodents and NHPs (equipment and study conduct)
  • Conformance with international health agency and drug control regulatory recommendations and guidelines
  • The experience, insights, and flexibility required for the development of customized models to appropriately characterize a wide range of therapeutic targets

Cardiovascular System

  • Remote telemetry monitoring in freely moving animals, including all contemporary models, with calibrated continuous data collection, using appropriate analytical methods for quantitative and qualitative data
  • Fully validated, non-invasive remote telemetry monitoring system for large animals provides an alternative to surgical instrumentation
  • Human iPS cardiomyocyte high- content imaging for determination of acute and chronic in vitro cardiotoxicity via profiling of multiplexed cellular targets, including characterization of non-ion channel toxicity mechanisms
  • hERG assessment via whole cell patch clamp
  • Restrained/anesthetized models
  • Cardiac output/arterial flow
  • Vascular/peripheral resistance
  • Ventricular pressure, pulmonary arterial pressure
  • Ultrasound/echocardiography

Respiratory System

  • Rate, volume, and supplemental derived respiratory mechanics parameters, blood gas analyses
  • Whole-body, head-out, and dual-chamber plethysmography in small animals
  • Remote, calibrated telemetry monitoring in freely moving animals with continuous data collection
  • Plethysmography in large animals
  • Lung resistance and compliance measures in anesthetized rodents

Central Nervous System

  • Functional Observational Battery (FOB) for small and large animals
  • Quantitative motor performance tests
  • Higher order neurofunctional endpoints
  • CNS electrophysiology (EEG-based sensory, motor, and generalized assessments, including quantitative methods)

Renal System

  • Urinary screening and definitive functional evaluations in multiple species

Gastrointestinal System

  • Gastric emptying in rodents
  • Gastrointestinal transit in multiple species
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Infusion Toxicology
Price on request

With solid infusion toxicology capabilities, the experts at MPI Research provide Sponsors with customized studies, extensive experience, and robust models. Doing so forges a strong partnership that many Sponsors find indispensable as they move their candidate along the drug development pathway. We are committed to assisting our... Show more »

With solid infusion toxicology capabilities, the experts at MPI Research provide Sponsors with customized studies, extensive experience, and robust models. Doing so forges a strong partnership that many Sponsors find indispensable as they move their candidate along the drug development pathway. We are committed to assisting our Sponsors to make a difference in people’s lives.

MPI Research offers industry-leading infusion toxicology capabilities and conducts studies across a variety of study designs. Our expert infusion team partners with Sponsors to support the development of their drug and to evaluate their needs to design the most appropriate, logistically feasible model for their infusion toxicology programs.

Service Highlights

  • Extensive capabilities in infusion technology, supported by knowledge and experience
  • Dedicated scientific and technical staff
  • Routine evaluation of studies by board- certified pathologists experienced in recognizing background pathologies inherent to infusion models
  • Robust models that allow design flexibility
    • Ambulatory infusion
    • Jacket-tether infusion
    • Peripheral percutaneous infusion
    • Multi-channel infusion
  • Infusion models in multiple species
    • Rodents
    • Canines
    • Rabbits
    • Swines
    • Nonhuman primates (including infant primates)
  • Long-term infusion capabilities
  • Dedicated surgical suite and support for small and large animal infusion procedures
  • Experienced veterinary and surgical staff, including surgeons certified by the Academy of Surgical Research

Advanced Electronic Data Support

  • Integrated, company-wide Provantis™ system for efficient and accurate data capture, entry, and reporting
    • In-life
    • Clinical pathology
    • Necropsy
    • Histopathology

Experience with a Variety of Compounds

  • Recombinant proteins, antibodies, peptides, other biopharmaceuticals
  • Large and small molecules
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ADME and DMPK Studies
Drug Metabolism and Pharmacokinetics
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Animal Models of Disease
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Animal Learning, Memory, and Behavior Tests
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Safety Pharmacology & Efficacy Testing
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Computational Modeling
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Pharmacology & Toxicology
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Cardiovascular Animal Models
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Bioavailability Studies
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Animal Model in vivo Analyses
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Purification Services
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Chromatography
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Animal Anxiety and Depression Tests
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Optical Microscopy
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Tandem Mass Spectrometry Methods
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Respiratory Disease Animal Models
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Respiratory Disease Animal Models Services

Respiratory Disease Animal Models Services

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Cardiovascular Toxicology
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In vivo Toxicity Testing
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Spectroscopy
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Animal Cognition & Behavior Tests
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Chemistry and Materials
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Toxicology
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Formulation & Manufacturing
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Liquid Chromatography
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Animal Models and Studies
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Imaging & Spectroscopy
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Analytical Chemistry Services
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Animal Physiology Analyses
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Computational & Statistical Analysis
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Cognitive, Behavioral, and Psychiatric Animal Models
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Mass Spectrometry
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Animal Motor Function Tests
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Microscopy
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