Drug Metabolism and Pharmacokinetics (DMPK)

DPMK

 

Frontage’s DMPK services help you start building a strong product foundation in early stages of drug discovery and development.

For pharmaceuticals, we conduct a range of  in vivo and in vitro ADME studies that are needed for selecting lead drug candidates in discovery or are required for regulatory filings of potential therapeutic agents. A range of capabilities and experience exist at Frontage Labs to support discovery and development of drug candidates.

For agrochemicals, we offer residual analyses, syntheses of metabolite standards and GLP in vivo/in vitro studies with radiolabeled compounds. For more information on our Agrochemical capabilities, click here.

Frontage is held to the highest quality standards. We have been inspected and shown to be in compliance with the rules and regulations mandated by the following agencies:

  • AAALAC
  • EPA
  • FDA
  • PA Bureau of Radiation Protection

DRUG DISCOVERY AND DEVELOPMENT

  • In vitro/in vivo ADME studies
  • AAALAC certified animal facility
  • State-of-the-art LC/MS and radioactivity detectors
  • Non-GLP bioanalytical lab for high throughput assays
  • Approved for studies with radiolabeled compounds

IN VITRO STUDIES

  • Lead optimization for candidate selection in drug discovery
  • Metabolic stability, plasma/blood stability, protein binding, blood/plasma partitioning, and CYP450 inhibition
  • Preclinical and human metabolism of drug candidates using liver microsomes and hepatocytes
  • Metabolic pathway identification using chemical inhibition, antibody inhibition, recombinant cDNA CYP450s and correlation analysis
  • Metabolite profiling,  identification, and structure elucidation
  • Aqueous solubility/log D

IN VIVO STUDIES

  • Pharmacokinetic studies in rodents, dogs and NHP. Rapid turnaround of PK data
  • Routes of drug administration: IV, PO, SC, IM, IT, and ID in rodents
  • Full formulation support
  • Animal surgeries conducted in-house including all  BDC rats
  • Dedicated Non-GLP Bioanalytical to support PK studies
  • PK/PD biomarker assessment
  • Manual or automated serial blood sampling to minimize animal usage
  • In vivo metabolite profiling/identification using non-labeled and radiolabeled compounds
  • Target Tissue Exposure
  • Salt/Formulation Selection

RADIO- AND STABLE ISOTOPE- LABELED STUDIES

  • Mechanistic or routine in vitro or in vivo metabolism studies with stable isotope labeled (13C, 2H) or radiolabeled (14C, 3H) compounds
  • Mass balance and excretion routes
  • Tissue distribution
  • Syntheses of stable isotope labeled compounds for metabolism studies