Generics and bioequivalence

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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.

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Title Statements

Full title :Generics and bioequivalence / edited by André J. Jackson.

Summary

Edition Statements

Publication Date:2019.

Publication Statements

Publisher(s):CRC Press
Place of Publication:Boca Raton
Language:eng
Publication Date:2019.

Notes

Originally published in 1994.

The Physical Object

Description:1 online resource

Edition Identifiers

ISBN:9780429558672, 0429558678, 0429263643, 9780429263644, 9780429554209, 0429554206, 9780429563140, 0429563140
DOI:10.1201/9780429263644
oclc:on1104836072
LC Classification:RM301.45
Dewey Decimal:615/.1

Statistical methods in bioequivalence / Eric Ormsby -- Role of single- and multiple-dose studies in the estimation of bioequivalency / Andre J. Jackson -- Role of metabolites in bioequivalency assessment / Mei-Ling Chen, Andre J. Jackson -- Analytical aspects of bioequivalency testing / James Leslie -- Pharmacodynamics and bioequivalence / Nicholas H.G. Holford -- In vivo and in vitro correlations: scientific and regulatory perspectives / Vinod P. Shah, Roger L. Williams -- Stereochemical considerations in bioavailability studies / William R. Ravis, Joel S. Owen.

Animal models and their role in bioequivalence studies / Wade J. Adams -- Issues in bioequivalence: an industrial scientist's perspective / Prem K. Narang -- Progress in harmonization of bioavailability and bioequivalence standards / Iain J. McGilveray.

Subjects

Drugs -- Bioavailability Drugs -- Therapeutic equivalency Drugs, Generic Generic drugs MEDICAL -- Pharmacology Médicaments -- Biodisponibilité Médicaments -- Équivalence thérapeutique Médicaments génériques Therapeutic Equivalency