Handbook of bioequivalence testing / Sarfaraz K. Niazi
By: Niazi, Sarfaraz
Material type:
Item type | Current location | Call number | Status | Date due | Barcode |
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Centeral Library Second Floor - Biotechnology | 615.7 N.S.H 2007 (Browse shelf) | Available | 12753-1 | |
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Centeral Library Second Floor - Biotechnology | 615.7 N.S.H 2007 (Browse shelf) | Available | 12743-1 |
Includes bibliographical references and index
Bioequivalence testing rationale and principles -- Regulatory aspect of bioequivalence testing -- Pharmacokinetic and pharmacodynamic modeling -- Waiver of bioavailability/bioequivalence studies -- Regulatory review process -- Statistical evaluation of bioequivalence data -- Physicochemical properties affecting bioequivalence -- Drug delivery factors -- Bioanalytical method validation -- Good clinical practice -- Good laboratory practice for nonclinical laboratory studies -- Computer and software validation -- Bioequivalence reports
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