Generics and Bioequivalence - Rilegato

Jackson, Andre J.

Rilegato

ISBN 10: 0849369304 ISBN 13: 9780849369308

Casa editrice: CRC Press, 1994

Riassunto

Generics and Bioequivalence provides a clear, insightful, and in-depth analysis of the many complex issues encountered in the determination of drug bioequivalence. Included are timely updates on many controversial and newly emerging areas in the design and analysis of bioavailability and bioequivalence studies. This new reference was prepared by a group of authorities from academe, industry, and government and can be easily understood by students and experienced scientists alike. Topics presented include the role of single and multiple dosing in the determination of bioequivalence, the role of metabolites in assessing bioequivalence, stereochemical considerations in bioequivalence evaluation, uses of animal models, pharmacodynamics, and statistics. The analysis of pharmacodynamic data (especially when plasma levels are unavailable) is covered, and the nascent importance of individual bioequivalence is examined.

Su questo libro

Contenuti

Statistical Methods in Bioequivalence (E. Ormsby). Role of Single- and Multiple-Dose Studies in the Estimation of Bioequivalency (A.J. Jackson). The Role of Metabolites in Bioequivalency Assessment (M.-L. Chen and A.J. Jackson). Analytical Aspects of Bioequivalency Testing (J. Leslie). Pharmacodynamics and Bioequivalence (N.H.G. Holford). In Vivo and In Vitro Correlations: Scientific and Regulatory Perspectives (V.P. Shah and R.L. Williams). Stereochemical Considerations in Bioavailability Studies (W.R. Ravis and J.S. Owen). Animal Models and Their Role in Bioequivalence Studies (W.J. Adams). Commentary I: Issues in Bioequivalence: An Industrial Scientist's Perspective (P.K. Narang). Commentary II: Progress in Harmonization of Bioavailability and Bioequivalence Standards (I.J. McGilveray).

Dettagli dell'edizione

• Editore: CRC Press
• Data di pubblicazione: 1994
• Lingua: Inglese
• ISBN 10: 0849369304
• ISBN 13: 9780849369308
• Rilegatura: Copertina rigida
• Numero edizione: 1
• Numero di pagine: 224
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile