Cover image for Handbook of bioequivalence testing
Title:
Handbook of bioequivalence testing
Author:
Niazi, Sarfaraz, 1949-
ISBN:
9780849383595
Publication Information:
New York : Informa Healthcare USA, c2007.
Physical Description:
xiv, 569 p. : ill.
Series:
Drugs and the pharmaceutical sciences ; v. 171
Series Title:
Drugs and the pharmaceutical sciences ; v. 171
Contents:
Bioequivalence testing rationale and principles -- Regulatory aspect of bioequivalence testing -- Pharmacokinetic/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 validations -- Bioequivalence reports.
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