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.

Our stage-dependent drug discovery bundles offer you the solutions you need to provide you with the insights to make informed decisions.

To talk to an expert about our DMPK Services, please click here.

drug metabolism pharmacokinetics

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:

  • In Vitro Metabolism (Clearance Rate and Mechanisms)
    • Multiple species microsomes, S9 & hepatocytes
  • Protein Binding & Nonspecific Tissue Binding (Fu)
    • Rapid equilibrium dialysis (multiple tissues)
  • Enzyme Reaction Phenotyping
    • Recombinantly expressed human P450 or HLM ± inhibitors
  • P450 Inhibition (Perpetrator, DDI – FDA Guidance)
    • Reversible and time-dependent inhibition (TDI)
  • Preclinical Metabolite Profiling (In Vitro/In Vivo/PK or Tox)
  • First-in-Human (Ph I) Metabolite Scouting (MIST)

You have access to our state-of-the-art in vitro molecular and cell-based tools to address your pharmacological mechanism and / or toxicological issues. We offer insights through an investigative approach to address mechanism of drug action (pharmacology) or toxicology issues which could limit your drug development. Supporting biomarker discovery, gene therapy and biotherapeutic programs with the following capabilities and expertise:

  • DNA/RNA Isolation
  • RT-PCR, qPCR
  • Flow Cytometry
  • Cytokine Panels
  • Protein Expression Analysis
  • ELISA (single and multiplex)
  • Definitive CYP Induction by mRNA
  • Transporter Assays: Solution Carrier (SLC) and ATP-Binding Cassette (ABC)
  • Hepatitis B Virus (HBV) Titers

To learn more about our pharmacology models we support click here.

At Inotiv, you have access to a broad range of In Vivo Discovery Pharmacokinetics and exploratory toxicology support including:

  • Leadership team ranging with an average of 25 years of experience
  • AALAS certified leadership
  • AALAC accredited facilities
  • Boilerplate PK Designs for Rapid Screening
  • Discrete and Cassette Rapid PK
    • Culex enabled/rodent (routine screening PK to bundle with in vitro metabolic clearance data, IVIVC)
    • Vascular/Extravascular Dosing
      • Intravenous (IV)
      • Oral (PO)
      • Subcutaneous (SC)
      • Intraperitoneal (IP)
      • Human Papillomavirus (HPV)
      • Intradermal (ID)
        • Manual or Culex
  • Continuous Infusion
    • Rat which is Culex enabled

Rodent In Vivo Drug Disposition Models:

  • Mechanistic Drug Disposition Study Designs
  • Bile Duct Cannulated (BDC) Rat
    • Clearance mechanisms, excretion
    • Culex automated sampling
    • Metabolism caging for refrigerated sample collections
  • Intra-Duodenal Dosing
    • BDC or Hepatic Portal Vein (HPV) sampling optional
  • HPV Dosing/Sampling
    • First pass metabolism, clearance mechanism
  • Tissue Distribution Assessment
    • Systemic circulation and tissue exposure

Get More Insight into our In Vivo Services

At Inotiv, you get the right questions answered at the right point in time. Our discovery bioanalysis provides a tiered approach of method qualification to harmonize with your need of rigor. From very basic screening to IND-enabling, we get you the data to make informed decisions quickly. 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
  • Liquid chromatography, tandem mass spectrometry utilizing the AB SCIEX™ platform (4000, 5500, 6500, 7500)
  • Contemporary method development using ballistic gradients, UPLC-ready columns
  • Tiered stage-appropriate rigor for bioanalysis
    • Level 1 for screening; Level 2 for non-GLP IND-enabling
  • High resolution mass spectrometry technology utilizing Thermo Exploris™, LTQ Orbitrap, and Agilent® 6550 Q-TOF
  • TECAN – liquid handling and assay automation
  • HT Tissue Cryo-homogenization & VAMS® processing
  • Watson LIMS™ (accessioning/PK analysis)

To learn more about our Bioanalytical services click here.

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:

  • Discovery through regulated PK/TK analyses
  • IND enabling report preparation (nonclinical pharmacology summary)
  • Exposure-effect modeling (PK/PD)
  • Nonclinical pharmacokinetic modeling (pharmacology and toxicology dose design)
  • Phoenix™ WinNonlin™ validated software
  • Watson LIMS™ noncompartmental PK analysis (NCA)
  • Human PK predictions and dose projections (allometric, single species scaling)
  • Internal and external consultants with diverse PK, PK/PD modeling experience