ADME/DMPK Profiling

Characterizing Drug Disposition and Pharmacokinetic Behavior

ADME/DMPK profiling generates quantitative data on absorption, distribution, metabolism, and excretion properties that help assess the likelihood of achieving adequate therapeutic exposure. These studies inform lead optimization decisions, support translational PK assumptions, and identify liabilities requiring structural modification before advancing candidates to regulatory toxicology.

Biotts provides ADME/DMPK profiling using in vitro assays and in vivo preclinical models designed to answer specific questions about compound behavior. Studies generate PK parameters, metabolic stability profiles, and distribution data suitable for internal decision-making and regulatory discussions.

Core Services

In Vitro ADME
Metabolic stability in liver microsomes and hepatocytes. Plasma protein binding and permeability assessment (e.g., Caco-2, PAMPA systems). CYP interaction screening as needed to evaluate drug-drug interaction potential.

In Vivo Pharmacokinetics
PK studies in rodent species (and non-rodent via qualified partners) with dose-dependent exposure assessment. Bioavailability determination across administration routes. PK/PD relationship establishment supporting dose selection for efficacy and toxicology programs.

Metabolite Profiling
LC-MS/MS analysis identifying major metabolic pathways and metabolites of interest. Cross-species comparison supporting human PK predictions where applicable.

Methodology & Deliverables

Bioanalysis follows validated or qualification-appropriate methods aligned with ICH M10 principles where applicable. PK parameters are calculated using non-compartmental analysis (or compartmental/population approaches depending on data richness).

Deliverables include:

  • Concentration-time profiles and calculated PK parameters
  • Metabolic stability and permeability data
  • Scientific interpretation supporting lead optimization decisions
  • Documentation suitable for IND packages or internal reports

Contact Biotts to discuss ADME/DMPK requirements for your program.

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Medicinal & synthetic chemistryIn vitro / In vivo PharmacologyToxicology studies