Niazi, Sarfaraz, 1949-

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

0849303958 (hardcover : alk. paper) 9780849303951 (hardcover : alk. paper)

2007010944

GBA747631 bnb

013773002 Uk 101301950 DNLM


Drugs--Therapeutic equivalency--Handbooks, manuals, etc.
Therapeutic Equivalency--United States.
Drug Approval--United States.
Models, Statistical--United States.

RM301.45 / .N52-2007

615/.7

QV 38 / N577h 2007 W1 / DR893B v.171 2007