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Bioanalytical Assays: Gas Chromatography (GC)

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

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Abstract

The quantitative determination of analytes in biological matrices such as blood and urine is called bioanalysis. Bioanalysis regulatory authorities and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance requires that the concentration-time profiles of drugs and/or metabolites in man or in animals are studied so their respective pharmacokinetics can be calculated and used as a basis for the evaluation of preclinical (especially toxicological) and clinical studies.

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Notes

  1. 1.

    The number of theoretical plates is the number of discrete distillations that would have to be performed to obtain an equivalent separation. This number is commonly used as a measure of separation efficiency and is a valuable number to use when comparing the performance of various chromatographic columns.

  2. 2.

    Successor company: Aventis Pharma Deutschland GmbH.

  3. 3.

    Recovery over the concentration range validated: 95–100% for PGE1, 86–89% for PGE0, and 91–93% for 15-keto-PGE0.

  4. 4.

    It responds to any molecule with a carbon–hydrogen bond, but not at all or poorly to compounds such as H2S, CCl4, or NH3.

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Authors and Affiliations

  1. DI & A DMPK, Sanofi Pharma Deutschland GmbH, Industriepark Höchst, Building G 877, 65926, Frankfurt, Germany

    Dietmar Schmidt

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  1. Dietmar Schmidt
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Correspondence to Dietmar Schmidt .

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Editors and Affiliations

  1. Sanofi Pharma Deutschland GmbH, A company of the Sanofi-Aventis Group Industriepark Hoechst, Frankfurt am Main, Germany

    Jochen Maas

  2. Dieburg, Germany

    Franz J. Hock

  3. Idstein, Germany

    Dieter Mayer

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Schmidt, D. (2013). Bioanalytical Assays: Gas Chromatography (GC). In: Vogel, H.G., Maas, J., Hock, F.J., Mayer, D. (eds) Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-25240-2_34

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