Niazi, Sarfaraz,  1949- <br/><br/>
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 .
<br/><br/>Includes bibliographical references and index 
<br/><br/>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 
<br/><br/><label>ISBN: </label>9780849303951 (hardcover : alk. paper) 0849303958 (hardcover : alk. paper) 0849383595 9780849383595 
<br/><br/><label>LCCN: </label>2007010944 
<br/><br/><label>Nat. Bib. No.: </label>GBA747631  bnb 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Drugs--Therapeutic equivalency--Handbooks, manuals, etc<br/>Therapeutic Equivalency--United States<br/>Drug Approval--United States<br/>Models, Statistical--United States
<br/><br/><label>LC Class. No.: </label>RM301.45  / .N53 2007 
<br/><br/><label>Dewey Class. No.: </label>615.7 
<br/><br/><label>National Library of Medicine Call No.: </label>W1  / DR893B v.171 2007 QV 38  / N577h 2007