Handbook of bioequivalence testing /
Sarfaraz K. Niazi.
- 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/pharmacodynamic modeling -- Waiver of bioavailability/bioequivalence studies -- Regulatory review process -- Statistical evaluation
Drugs--Therapeutic equivalency--Handbooks, manuals, etc. Therapeutic Equivalency--United States. Drug Approval--United States. Models, Statistical--United States.