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LC-MS/MS Bioanalysis Method Development, Validation, and Sample Analysis: Points to Consider When Conducting Nonclinical and Clinical Studies in Accordance with Current Regulatory Guidances

M. Whitmire,Jennifer Ammerman,P. D. Lisio,Jacqueline D. Killmer,Devon Kyle,Emily Mainstone,L. Porter,T. Zhang

Published 2011 in Journal of analytical and bioanalytical techniques

ABSTRACT

Recently, there has been a heightened public awareness of drug safety across the globe. Nonclinical and clinical pharmacokinetic and toxicokinetic toxicology safety studies all require that the study samples be analyzed under the auspices of good laboratory practice (GLP) standards. GLPs are followed in order to ensure that safety studies are reliable and accurate. Several countries have issued or are in the process of issuing their own versions of bioanalytical guidance documents for performing method validation activities; however, each one is slightly different. These differences often make complying with regulatory requirements difficult and cumbersome. Several networking organizations have been working diligently to harmonize the various global bioanalytical guidance documents. This paper attempts to shed light on some of the critical points to consider when performing bioanalytical method development and GLP compliant validation activities from a scientist’s perspective.

PUBLICATION RECORD

  • Publication year

    2011

  • Venue

    Journal of analytical and bioanalytical techniques

  • Publication date

    Unknown publication date

  • Fields of study

    Medicine, Chemistry, Computer Science

  • Identifiers
    DOI 10.4172/2155-9872.S4-001
  • External record

    Open on Semantic Scholar

  • Source metadata

    Semantic Scholar

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