Shargel ,Leon . <br/><br/>
Generic drug product development  solid oral dosage forms /  [[Book] :] 
Leon Shargel, Isadore Kanfer. 
 - New York :  Marcel Dekker,  2005. 
 - xi, 381 p. :  ill. ;  24 cm. 
 - Drugs and the pharmaceutical sciences ;  v. 143. .
<br/><br/> includes index. 
<br/><br/>Includes bibliographical references and index. 
<br/><br/> Introduction to generic drug product development /.  Active pharmaceutical ingredients /.  Analytical methods development and methods validation for solid oral dosage forms /.  Experimental formulation development /.  Scale-up, process validation, and technology transfer /.  Drug stability /.  Quality control and quality assurance /.  Drug product performance, in vitro /.  ANDA regulatory approval process /.  Bioequivalence and drug product assessment, in vivo /.  Statistical considerations for establishing bioequivalence /.  Scale-up, post-approval changes, and post-marketing surveillance /.  Outsourcing bioavailability and bioequivalence studies to contract research organizations /.  Legal and legislative hurdles to generic drug development, approval, and marketing /.  Leon Shargel, Izzy Kanfer --  Edward M. Cohen, Lih-Yang Lin --  Quanyin Gao, Robert Vita, Dilip R. Sanvordeker --  Izzy Kanfer, Peter Persicaner, Roderick B. Walker --  Salah C. Ahmed, Venkatesh Naini, Dilip Wadgaonkar --  Pranab K. Bhattacharyya --  Loren Gelber, Joan Janulis --  Pradeep M. Sathe ... [et al.] --  Timothy W. Ames ... [et al.] --  Dale P. Conner, Barbara M. Davit --  Sanford Bolton --  Sadie M. Ciganek ... [et al.] --  Patrick K. Noonan --  Arthur Y. Tsien. 
<br/><br/> All age. 
<br/><br/><label>ISBN: </label>0824754603 
<br/><br/><label>LCCN: </label>2005040476 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Generic drugs.<br/>Solid dosage forms.
<br/><br/><label>LC Class. No.: </label>RS55.2  / .G455 2005 
<br/><br/><label>Dewey Class. No.: </label>615.19 
<br/><br/><label>National Library of Medicine Call No.: </label> / SG