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Inotiv offers a broad scope of expertise for drug metabolism and pharmacokinetics (DMPK) studies at all stages of R&D, from lead optimization through new drug application (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

In Vivo Discovery Services

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

  • Leadership team with an average of 25 years of experience
  • AALAS certified leadership
  • AAALAC 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

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:

  • 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

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