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Book Cover
E-book
Author Niazi, Sarfaraz, 1949-

Title Handbook of bioequivalence testing / Sarfaraz K. Niazi
Published New York : Informa Healthcare USA, ©2007

Copies

Description 1 online resource (xiv, 569 pages) : illustrations
Series Drugs and the pharmaceutical sciences ; v. 171
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
Summary Offers the description of various aspects of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Drugs -- Therapeutic equivalency -- Handbooks, manuals, etc
Drugs -- Therapeutic equivalency.
Therapeutic Equivalency
Drug Approval
Models, Statistical
MEDICAL -- Pharmacology.
Drugs -- Therapeutic equivalency
Médicaments -- Équivalence thérapeutique.
SUBJECT United States
Genre/Form handbooks.
Handbooks and manuals
Handbooks and manuals.
Guides et manuels.
Form Electronic book
ISBN 9780849383595
0849383595