Gopalaswamy, Smita <br/><br/>
Combination products :  regulatory challenges and successful product developement / 
Smita Gopalaswamy, Venky Gopalaswamy 
 - Boca Raton :  CRC Press,  2008 
 - xvi, 241 p. :  ill. ;  25 cm. 
<br/><br/>Overview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges 
<br/><br/><label>ISBN: </label>9781420064469 (hardcover : alk. paper) 1420064460 (hardcover : alk. paper) 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Equipment Design--standards--United States<br/>Pharmaceutical Preparations--standards--United States<br/>Biological Products--standards--United States<br/>Device Approval--standards--United States<br/>Equipment and Supplies--standards--United States
<br/><br/><label>National Library of Medicine Call No.: </label>QV26  / .G659c 2008 9