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Related Experiment Videos

Bioanalytical data in decision making: discovery and development.

D A Smith1, K Beaumont, N J Cussans

  • 1Department of Drug Metabolism, Pfizer Central Research, Sandwich, Kent, UK.

Xenobiotica; the Fate of Foreign Compounds in Biological Systems
|September 1, 1992
PubMed
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Integrating bioanalysis into drug discovery significantly impacts development. Pharmacokinetic data from early stages, including half-life and bioavailability, are crucial for designing better drugs and guiding clinical trials.

Area of Science:

  • Pharmacology
  • Drug Development
  • Analytical Chemistry

Background:

  • Bioanalysis is often overlooked during the drug discovery phase, despite its significant impact on drug development.
  • Conventional structure-activity relationships can be enhanced by incorporating pharmacokinetic parameters like half-life and bioavailability.
  • Early bioanalytical data from discovery and preclinical studies are vital for informing early clinical programs.

Purpose of the Study:

  • To highlight the impact of bioanalysis in drug discovery programs.
  • To emphasize the value of pharmacokinetic studies alongside pharmacology screening.
  • To demonstrate how bioanalytical data guides early clinical development.

Main Methods:

  • Utilizing bioassays as a common assay system for numerous compounds in discovery.

Related Experiment Videos

  • Combining bioassays with high-performance liquid chromatography (HPLC) to detect active metabolites.
  • Generating pharmacokinetic data at incremental doses during early clinical studies.

    • Main Results:

    • Pharmacokinetic studies provide critical information beyond traditional structure-activity relationships.
    • Bioassays combined with HPLC facilitate the identification of active metabolites.
    • Generating plasma concentration-response data in preclinical studies allows for comparison with human data.

    Conclusions:

    • Incorporating bioanalysis early in drug discovery can lead to improved drug design.
    • Bioanalytical data from discovery and preclinical phases are essential for successful clinical trial design.
    • Continuous pharmacokinetic data generation during dose escalation enhances the transition from preclinical to clinical studies.