Analytical Aspects of Bioequivalence Chromatographic Science Series

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.

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.

Andrei Medvedovici: born Nov. 29'",1961; 1984 - B.Sc. in Chemistry, Polytechnic University of Bucharest, Faculty of Chemistry; 1985 - M.Sc. in Analytical Chemistry, Polytechnic University of Bucharest, Faculty of Chemistry; 1992 - pre-doctoral stage at the University of Ghent -Belgium; 1994 - Ph.D. in Chemistry, University of Bucharest, Faculty of Chemistry; 1994 - 1997 post-doctoral studies at the University of Ghent -Belgium and Research Institute for Chromatography, Kortrijk, Belgium (coordinator: Prof. Dr. Pat Sandra); from 1990 at the University of Bucharest, Faculty of Chemistry, Department of Analytical Chemistry (teaching assistant, lecturer, associated professor); from 2005 professor at the same institution; from 2006, Ph.D. coordinator (same institution); 2002-2009 - R&D director, Labormed Pharma; from 2009 - Scientific director, Labormed Group; Editorial board member at Bioanalysis and Journal of Liquid Chromatography & Related Technologies; 2009 - Prize "C.D. Nenitescu" of the Romanian Academy for the cycle of publications on applications of LC/MS in biomedical field; lSI publications: 86 (72 abroad Romania); non-lSI publications: 13 (12 abroad Romania); published courses, contributions in monographs and encyclopedias: 25 (14 abroad Romania); cumulated impact factor: - 140; citation index: 491; h-index: 12.

Victor David: born February 261h 1955; 1979 - B.Sc. in Chemistry, Polytechnic University of Bucharest, Faculty of Chemistry; 1980 - M.Sc. in Analytical Chemistry, Polytechnic University of Bucharest, Faculty of Chemistry; 1989 - Ph.D. in Chemistry, Polytechnic University of Bucharest, Faculty of Chemistry; from 1992, in the Analytical Department of the Faculty of Chemistry, University of Bucharest (1992 - lecturer, 1997 - associated professor, 2002 - professor, 2005 - Ph.D. cooridination); Editorial board member at Journal of Essential Oils Bearing Plants and Open Automation and Control Systems Journal (Bentham Publ