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Related Experiment Videos

The clinical laboratory in pharmaceutical development

K C Gunter1, R C Rock

  • 1Department of Laboratory Medicine, Children's National Medical Center, Washington, D.C. 20010, USA.

Therapeutic Drug Monitoring
|April 1, 1995
PubMed
Summary
This summary is machine-generated.

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Clinical laboratories are vital for pharmaceutical development. Laboratory testing in clinical trials may differ from routine analysis, requiring specialized management by trained directors.

Area of Science:

  • Clinical chemistry
  • Pharmaceutical research
  • Laboratory medicine

Background:

  • The clinical laboratory is integral to pharmaceutical agent development.
  • Its role evolves with drug development stages and research objectives.
  • Standard clinical analysis methods may not always apply to clinical trials.

Purpose of the Study:

  • To highlight the critical role of clinical laboratories in drug development.
  • To emphasize the need for tailored laboratory testing approaches in clinical trials.
  • To underscore the importance of laboratory director expertise.

Main Methods:

  • This study reviews the functions and requirements of clinical laboratories in pharmaceutical research.
  • It discusses the adaptation of laboratory testing protocols for clinical trial settings.

Related Experiment Videos

  • Expertise of laboratory directors in managing trial testing is examined.

    • Main Results:

    • Clinical laboratory functions vary significantly based on the phase of drug development.
    • Distinct methodologies are often required for clinical trial laboratory tests compared to routine diagnostics.
    • Effective prospective and on-site management by qualified laboratory directors is crucial.

    Conclusions:

    • Clinical laboratories are essential partners in bringing new drugs to market.
    • Adapting laboratory testing and management is key to successful clinical trials.
    • The specialized knowledge of laboratory directors ensures reliable trial data.