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Handbook of bioequivalence testing / Sarfaraz K. Niazi

By: Material type: TextTextSeries: 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
Subject(s): DDC classification:
  • 615.7 22
LOC classification:
  • RM301.45 .N53 2007
NLM classification:
  • W1
  • QV 38
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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Holdings
Item type Current library Call number Status Date due Barcode
Books Books Centeral Library Second Floor - Biotechnology 615.7 N.S.H 2007 (Browse shelf(Opens below)) Available 12753-1
Books Books Centeral Library Second Floor - Biotechnology 615.7 N.S.H 2007 (Browse shelf(Opens below)) 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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