Generics and Bioequivalence

1. Auflage 2020
ISBN: 978-0-367-20831-8
Verlag: Taylor & Francis

Buch, Englisch, 203 Seiten, Format (B × H): 156 mm x 234 mm, Gewicht: 535 g

Reihe: Routledge Revivals

Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.

Zielgruppe

Professional

Autoren/Hrsg.

Jackson, André J.

Weitere Mitwirkende

Chen, Mei-Ling

Narang, Prem K.

Ravis, William R.

Holford, Nicholas H. G.

Adams, Wade J.

Leslie, James

Dighe, Shrikant V.

Augsburger, Larry L.

Shangraw, Ralph F.

Shah, Vinod P.

Lin, Tsai-Lien

Schuirmann, Donald J.

Williams, Roger L.

Owen, Joel S.

McGilveray, Iain J.

Ormsby, Eric D.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Naturwissenschaften Chemie Analytische Chemie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie

Inhaltsverzeichnis

1. Statistical Methods in Bioquivalence
Eric Ormsby

2. Role of Single- and Multiple Dose Studies in the Estimation of Bioquivalence
Andre J. Jackson

3. Role of Metabolites in Bioquivalency Assessment
Mei-Ling Chen and Andre J. Jackson

4. Analytical Aspects of Bioquivalency Testing
James Leslie

5. Pharmacodynamics and Bioquivalence
Nicholas H. G. Holford

6. In Vivo and In Vitro Correlations: Scientific and Regulatory Perspectives
Vinod P. Shah and Roger L. Williams

7. Stereochemical Considerations in Bioavailability Studies
William R. Ravis and Joel S. Owen

8. Animal Models and Their Role in Bioquivalence Studies

Wade J. Adams

Über Autor(innen)

Andre J. Jackson Ph.D., is a reviewer at the U.S. Food and Drug Administration Office of Generic Drugs in the Center for Drug Evaluation and Research.