Handbook of bioequivalence testing /
Sarfaraz K. Niazi
- 1st ed.
- New York : Informa Healthcare USA, c2007
- xiv, 569 p. : ill. ; 27 cm
- Drugs and the pharmaceutical sciences ; v. 171 .
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
Drugs--Therapeutic equivalency--Handbooks, manuals, etc Therapeutic Equivalency--United States Drug Approval--United States Models, Statistical--United States