Main description:

Active chemical compounds in the pharmaceutical products existing on the market need to be characterized with respect to their properties, or compared to other similar products, already available for direct use. The book describes sampling methodologies, preparation methods, separation possibilities and assay of these compounds at low concentration levels in complex matrixes. The steps covered are taken before launching a new pharmaceutical product on the market for estimating its pharmacokinetic behavior, or before authorizing for marketing of a generic pharmaceutical product.

Contents:

Bioavailability I bioequivalence (BAlBE). What is BAlBE? The biopharmaceutical basis of BAIBE studies. A short history of BAIBE. Aims of BAIBE studies: relevance for the proposed scope? Stages of BAIBE studies. Designs for BE studies. Metabolization & metabolite analysis in BAIBE studies. Enantioselective requirements in BAIBE studies. Regulatory aspects for clinical BAIBE approaches: Good Clinical Practices. Sample preparation in bioanalytical methods. Biomatrixes in BAIBE studies (blood; plasma, serum; urine; other biological fluids). Sample collection, primary preparation and storage. Liquid-liquid based extraction techniques. Protein precipitation methods. Solid Phase Extraction in BAIBE studies. Derivatization for BAIBE. Additional cleanup methods. Chromatographic separations in BAIBE studies. Gas chromatography in BAIBE studies. Liquid and supercritical fluid chromatography in BAlBe studies. Detection for chromatographic approaches in BAiBE applications. Detection for gas chromatography in BAiBE applications. Detection for liquid chromatography in BAiBE applications. Development and validation of bio analytical methods. Performance qualification of analytical instrumentation. Spiking Bio matrixes. Development of BAiBE chromatographic methods. The choice of the quantitation method (external standard, internal standard, standard addition). Choice of internal standards in BAiBE methods. Method validation. Good (bio) laboratory practices (GLP). Incurred sample analysis in BAiBE approaches. The analytical sequence. Criteria for analytical sequence validation. Global quality criteria in evaluation of a BAiBE study. Incurred sample reanalysis. Analytical data processing in BAiBE. Reporting analytical data. Pharmacokinetic parameters (principal & secondary PK). Analysis of data. Structure and quality of data. Distribution of data. Statistical tests. Multivariate data analysis. Dedicated softwares for statistical assessment of bioequivalence. General conclusions.