Handbook of bioequivalence testing. (©2007)

• Record Type: Book
• Further Information: Note: Sarfaraz K. Niazi.
• Other Names: Niazi, Sarfaraz, 1949-
• 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.
• Publisher Details: New York : Informa Healthcare USA
• Publication Date: 2007
• Copyright Date: 2007
• Extent: 1 online resource, illustrations
• Subjects: 615.7; Drugs -- Therapeutic equivalency -- Handbooks, manuals, etc; Drugs -- Therapeutic equivalency; Médicaments -- Équivalence thérapeutique; United States; Handbooks and manuals
• Languages: English
• ISBNs: 0849383595; 9780849383595
• Related ISBNs: 9780849303951; 0849303958
• Notes: Note: Includes bibliographical references and index.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.