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Handbook of bioequivalence testing / Sarfaraz K. Niazi

By: Niazi, Sarfaraz, 1949-
Material type: TextTextSeries: Drugs and the pharmaceutical sciences ; v. 171Publisher: New York : Informa Healthcare USA, c2007Edition: 1st edDescription: xiv, 569 p. : ill. ; 27 cmISBN: 9780849303951 (hardcover : alk. paper); 0849303958 (hardcover : alk. paper); 0849383595; 9780849383595Subject(s): Drugs -- Therapeutic equivalency -- Handbooks, manuals, etc | Therapeutic Equivalency -- United States | Drug Approval -- United States | Models, Statistical -- United StatesDDC classification: 615.7 LOC classification: RM301.45 | .N53 2007
Contents:
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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Item type Current location Call number Status Date due Barcode
Books Books Centeral Library
Second Floor - Biotechnology 		615.7 N.S.H 2007 (Browse shelf) Available 12753-1
Books Books 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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