Handbook of bioequivalence testing / Sarfaraz K. Niazi
Material type: TextSeries: Drugs and the pharmaceutical sciences ; v. 171Publication details: New York : Informa Healthcare USA, c2007Edition: 1st edDescription: xiv, 569 p. : ill. ; 27 cmISBN:- 9780849303951 (hardcover : alk. paper)
- 0849303958 (hardcover : alk. paper)
- 0849383595
- 9780849383595
- 615.7 22
- RM301.45 .N53 2007
- W1
- QV 38
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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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