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    Modern Bio-Analytical Techniques (MPA 202T)

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    This document provides an overview of a course on modern bio-analytical techniques. The course aims to provide knowledge about analyzing drugs in biological samples. It will cover extracting drugs from samples, separating drugs using different techniques, and guidelines for bioavailability and bioequivalence studies. The course consists of 60 hours of theory across 5 topics: extraction techniques, biopharmaceutical considerations, pharmacokinetics and toxicokinetics, cell culture techniques, and metabolite identification. References are also provided.

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    Modern Bio-Analytical Techniques (MPA 202T)

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    pharma xl
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    This document provides an overview of a course on modern bio-analytical techniques. The course aims to provide knowledge about analyzing drugs in biological samples. It will cover extracting drugs from samples, separating drugs using different techniques, and guidelines for bioavailability and bioequivalence studies. The course consists of 60 hours of theory across 5 topics: extraction techniques, biopharmaceutical considerations, pharmacokinetics and toxicokinetics, cell culture techniques, and metabolite identification. References are also provided.

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    This document provides an overview of a course on modern bio-analytical techniques. The course aims to provide knowledge about analyzing drugs in biological samples. It will cover extracting drugs from samples, separating drugs using different techniques, and guidelines for bioavailability and bioequivalence studies. The course consists of 60 hours of theory across 5 topics: extraction techniques, biopharmaceutical considerations, pharmacokinetics and toxicokinetics, cell culture techniques, and metabolite identification. References are also provided.

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    2K views2 pages

    Modern Bio-Analytical Techniques (MPA 202T)

    Uploaded by

    pharma xl
    This document provides an overview of a course on modern bio-analytical techniques. The course aims to provide knowledge about analyzing drugs in biological samples. It will cover extracting drugs from samples, separating drugs using different techniques, and guidelines for bioavailability and bioequivalence studies. The course consists of 60 hours of theory across 5 topics: extraction techniques, biopharmaceutical considerations, pharmacokinetics and toxicokinetics, cell culture techniques, and metabolite identification. References are also provided.

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    of 2

    MODERN BIO-ANALYTICAL TECHNIQUES

    (MPA 202T)
    Scope
    This subject is designed to provide detailed knowledge about the importance of
    analysis of drugs in biological matrices.

    Objectives
    Upon completion of the course, the student shall be able to understand
     Extraction of drugs from biological samples
     Separation of drugs from biological samples using different techniques
     Guidelines for BA/BE studies.

    THEORY 60 Hrs
    1. Extraction of drugs and metabolites from biological matrices: 12
    General need, principle and procedure involved in the Hrs
    Bioanalytical methods such as Protein precipitation, Liquid -
    Liquid extraction and Solid phase extraction and other novel
    sample preparation approach.
    Bioanalytical method validation: USFDA and EMEA guidelines.

    2 Biopharmaceutical Consideration: 12
    Introduction, Biopharmaceutical Factors Affecting Drug Hrs
    Bioavailability, In Vitro: Dissolution and Drug Release Testing,
    Alternative Methods of Dissolution Testing Transport models,
    Biopharmaceutics Classification System. Solubility: Experimental
    methods. Permeability: In-vitro, in-situ and In-vivo methods.

    3 Pharmacokinetics and Toxicokinetics: 12


    Basic consideration, Drug interaction (PK-PD interactions), The Hrs
    effect of protein-binding interactions, The effect of tissue-binding
    interactions, Cytochrome P450-based drug interactions, Drug
    interactions linked to transporters. Microsomal assays
    Toxicokinetics-Toxicokinetic evaluation in preclinical studies,
    Importance and applications of toxicokinetic studies. LC-MS in
    bioactivity screening and proteomics.

    4 Cell culture techniques 12


    Basic equipments used in cell culture lab. Cell culture media, Hrs
    various types of cell culture, general procedure for cell cultures;
    isolation of cells, subculture, cryopreservation, characterization of
    cells and their applications. Principles and applications of cell
    viability assays (MTT assays), Principles and applications of flow
    cytometry.

    5 Metabolite identification: 12
    In-vitro / in-vivo approaches, protocols and sample preparation. Hrs
    Microsomal approaches (Rat liver microsomes (RLM) and Human
    liver microsomes (HLM) in Met –ID. Regulatory perspectives.
    In-vitro assay of drug metabolites & drug metabolizing enzymes.

    Drug Product Performance, In Vivo: Bioavailability and


    Bioequivalence:
    Drug Product Performance, Purpose of Bioavailability Studies,
    Relative and Absolute Availability. Methods for Assessing
    Bioavailability, Bioequivalence Studies, Design and Evaluation of
    Bioequivalence Studies, Study Designs, Crossover Study
    Designs, Generic Biologics (Biosimilar Drug Products), Clinical
    Significance of Bioequivalence Studies.

    REFERENCES
    1. Analysis of drugs in Biological fluids - Joseph Chamberlain, 2nd Edition.
    CRC Press, Newyork. 1995.
    2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
    Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
    3. Pharmaceutical Analysis - Higuchi, Brochmman and Hassen, 2nd Edition,
    Wiley – Interscience Publications, 1961.
    4. Pharmaceutical Analysis- Modern methods – Part B - J W Munson,
    Volume 11, Marcel Dekker Series
    5. Practical HPLC method Development – Snyder, Kirkland, Glaich, 2nd
    Edition, John Wiley & Sons, New Jercy. USA.
    6. Chromatographic Analysis of Pharmaceuticals – John A Adamovics, 2nd
    Edition, Marcel Dekker, Newyork, USA. 1997.
    7. Chromatographic methods in clinical chemistry & Toxicology – Roger L
    Bertholf, Ruth E Winecker, John Wiley & Sons, New Jercy, USA. 2007.
    8. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol.
    69, Marcel Dekker Series, 1995.
    9. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38,
    Marcel Dekker Series, 1989.
    10. ICH, USFDA & CDSCO Guidelines.
    11. Palmer

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