Inotiv offers a broad scope of expertise for drug metabolism and pharmacokinetics (DMPK) studies at all stages of R&D, from lead optimization through NDA. Benefit from our long and impeccable regulatory history, world-class team of scientists, and 40+ year track record of providing leading pharma and biotech companies with attentive, decisive analytical services — and high-quality data.

Save time and cost with fit-for-purpose bioanalytical services

At Inotiv, you get the right question answered at the right point in time. We provide three standard tiers of bioanalytical method qualification, from very basic discovery at the entry level, up through full regulatory-enabling GLP bioanalysis.

Expect more of your bioanalytical method development and sample analysis with:

  • High-capacity, high-throughput GLP/GCP bioanalysis for small molecules
  • Non-GLP discovery bioanalysis
  • Drug-drug interaction (DDI), ADME, PK, toxicology, and bioequivalence studies  
  • Combination medical device drug development
  • Large analytical method library
  • Fast sample analysis turnaround
  • High-quality data
  • Exemplary regulatory compliance

Deploy powerful bioanalytical tools and capabilities:

  • LC-MS/MS (triple quadrupole and QTRAP)
  • UHPLC and HPLC
  • Automated 96-well sample preparation
  • Conventional HPLC with UV, fluorescence, conductivity, and electrochemical detection

 Get the Insights You Deserve

Access Our Assays

For in vitro drug metabolism: Get fit-for-purpose assays with the right degree of rigor, at the right time

Flexible and diverse, our in vitro services deliver screening assays that facilitate your trials, novel assays that answer your questions, and routine in vitro services that enable your regulatory filings:

A partial list of our offerings includes:

  • Metabolic stability/intrinsic clearance
  • Plasma protein binding (equilibrium dialysis and ultrafiltration)
  • Red blood cell partitioning/blood to plasma ratio
  • Cytochrome P450 characterization of metabolism/drug-drug interaction assays
  • Metabolite ID/metabolic profiling
  • Physicochemical property assessment

We help with:

  • Development assistance — comparative binding
  • Method development and validation
  • Bioequivalence study variable determination guidance
  • Equilibrium binding studies
  • Kinetic binding studies
  • Dissolution bioequivalence studies
  • Final reports with electronic data, to statisticians

Play by the rules with a sound, scientific, regulatory plan for your in vitro bioequivalence studies

Tap into Inotiv’s proven experience in pharmaceutical product testing and our expertise with FDA regulations such as FDA 21CFR320 and FDA product-specific guidances to ensure compliance in bioequivalence studies.

In Vivo Services

Implement customized DMPK protocols and bioanalytical approaches at our AAALAC-accredited facility featuring:

  • A large, automated sampling lab
  • Integration with state-of-the-art bioanalytical labs
  • Quick turnaround for PK-PD results

Get More Insight Into Our In Vivo Services

Obtain Pharmacokinetics, Toxicokinetics, and Modeling Insights for Your Data

Whatever the source of your data, we will perform PK-TK analyses to evaluate dose, DDI potential, bioequivalence/bioavailability, and/or clinical PK projections. You benefit from:

  • PK-TK analysis of our own or externally generated data
  • A wide variety of protocols for all PK parameters, including in vivo
  • Assistance with protocol writing, regulatory reporting, and other documentation
  • A dedicated pharmacokineticist from our team expertly evaluating your drug candidate throughout its life cycle