Generic drug product development : bioequivalence issues / [edited by]Isadore Kanfer, Leon Shargel.
Material type:
TextSeries: Drugs and the pharmaceutical sciences ; 180Publication details: New York : Informa Healthcare, c2008.Description: x, 264 p. : ill. ; 24 cmISBN: - 9780849377846 (hardcover : alk. paper)
- 0849377846 (hardcover : alk. paper)
- 615/.1Â 22
- RM301.45Â .G42 2008
| Item type | Current library | Collection | Call number | Copy number | Status | Barcode | |
|---|---|---|---|---|---|---|---|
| E-BOOKS | MWALIMU NYERERE LEARNING RESOURCES CENTRE-CUHAS BUGANDO | NFIC | 615.1 (Browse shelf(Opens below)) | EBS13529 | -1 | EBS13529 |
Includes bibliographical references and index.
Introduction-- bioequivalence issues / Isadore Kanfer and Leon Shargel -- Approved drug products with therapeutic equivalence evaluations (the orange book) / Loren Gelber -- Pharmaceutical alternatives : considerations for generic substitution / Roderick B. Walker, Roger K. Verbeeck, Isadore Kanfer -- Pharmacodynamic measurements for determination of bioequivalence / Manish Issar, Jeffrey G. Stark, and Leon Shargel --
Bioequivalence using clinical endpoint studies / Christopher Hendy -- Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi -- Statistical considerations: alternate designs and approaches for bioequivalence assessments / Stanford Bolton and Charles Bon --
Population pharmokinetic approaches for assessing bioequivalence / Philippe Colucci, Jean-Francois Marier, and Murray P. Ducharme -- Role of metabolites in bioequivalence assessent / André Jackson -- Implications of chirality for the assessment of bioequivalence / Reza Mehvar and Fakhreddin Jamali --
Effect of food on bioavailability and the assessment of bioequivalence / Kim Dalhoff and Isadore Kanfer -- Bioequivalence assessment of endogenous drug substances: pharmacokinetics and statistical evaluation / Philippe Colucci ... [et al.].
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