Pre-Clinical Services


Our scientists at Vipragen design and conduct PK studies to examine multiple parameters in support of regulatory submissions with a range of analytical support, including LC-MS/MS, HPLC, CE or immunochemistry. Toxicokinetic assessments are conducted with ongoing toxicology programs and in compliance with GLP requirements.

In Vivo Pharmacokinetic/toxicokinetic

Administration Routes and Collection

  • Single agents, cassette dosing, single dose and repeat dose
  • Dosing by PO, IV, IP, SC, etc.
  • Tissue, urine and CSF collection

We provide support Services

  • Fully integrated bioanalysis services

  • Bioavailability and bioequivalence
  • Excretion (Bile, urine and Feces)
  • Mass balance
  • Tissue distribution studies (in rodents)
  • Dose linearity (multiple dose)
  • Dose proportionality (ascending dose)
  • Blood brain barrier
  • Toxicokinetics in rodents and non-rodents

In Vitro ADME

In Vitro ADME assays are an important part of a successful drug development program aiding in the critical decision-making process by offering metabolic information about drug-drug interactions, pharmacokinetics, absorption and potential toxicities. Our wide range of in vitro assays performed under GLP conditions, yield information in the areas of metabolism, toxicity and physicochemical characteristics of your product.

  • Solubility & Physicochemical Characterization - LogP & LogD
  • Permeability -PAMPA, MDCK & Caco -2:A-B and B-A direction & MDCK - MDR1-A-B and B-A direction
  • Metabolite Characterization
  • Plasma Protein Binding (Rapid equilibrium dialysis method -In Mice, Rat, Dog and Human
  • Stability -Plasma Stability, Simulated Gastric / Intestinal Stability & Liver Microsomal Stability (Mice, Rat, Dog and Human
  • Isozyme Characterization
  • In vitro drug-Drug Interaction -Cytochrome P450 Inhiblition Assays, Time Dependent Inactivation Assays, Recombinant CYP P450 / Pooled Human Liver Microsomes, Fluorescent Based Assays, Probe Substrate Assays
  • In vitro Blood-Brain Barrier Studies

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