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Related Experiment Videos

Changing need for bioanalysis during drug development.

Nuggehally R Srinivas1

  • 1Global Drug Development, ClinTec (India) International Pvt. Ltd., Bangalore 560 025, India. nsrinivas@clintec.com

Biomedical Chromatography : BMC
|October 17, 2007
PubMed
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This review outlines the evolving role of bioanalysis in drug development, from initial discovery to market authorization. It provides a framework for understanding bioanalytical strategies across discovery, preclinical, and clinical stages for novel chemical entities.

Area of Science:

  • Pharmacokinetics and Pharmacodynamics
  • Drug Development
  • Bioanalytical Chemistry

Background:

  • Bioanalysis is crucial for characterizing novel chemical entities (NCEs).
  • Existing reviews cover specific scientific and technical aspects, including chirality.
  • A comprehensive overview addressing the dynamic nature of bioanalysis throughout drug development is needed.

Purpose of the Study:

  • To provide a comprehensive review of bioanalytical aspects throughout the drug development lifecycle.
  • To address the changing requirements and applications of bioanalysis from NCE discovery to market authorization.
  • To offer a general framework for approaching bioanalysis from lead molecule inception through all development stages.

Main Methods:

  • Review of scientific and technical literature on bioanalysis.

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  • Discussion of bioanalytical applicability based on the nature, rigor, and choices of analyses.
  • Structured presentation of bioanalytical aspects across discovery, preclinical, and clinical stages.

    • Main Results:

    • Highlights the versatility and evolving applicability of bioanalytical methods.
    • Demonstrates the integral role of bioanalysis in pharmacokinetic/pharmacodynamic characterization.
    • Provides insights into adapting bioanalytical strategies based on the stage of NCE development.

    Conclusions:

    • Bioanalysis is an indispensable component of modern drug development.
    • A stage-specific approach to bioanalysis is essential for successful NCE progression.
    • This review offers a foundational framework for strategic bioanalytical planning.