02037nam a2200373 a 4500 vtls000046904 KUKTEM 20251117144412.0 100705t2008 flua f b 001 0 eng d 9781420064469 (hardcover : alk. paper) 1420064460 (hardcover : alk. paper) 201107131934 VLOAD 201106031148 Fida 201011021700 fauzi 201007051417 shikin UMP RM301.27 .G67 2008 Gopalaswamy, Smita Combination products : regulatory challenges and successful product developement / Smita Gopalaswamy, Venky Gopalaswamy Boca Raton : CRC Press, c2008 xvi, 241 p. : ill. ; 25 cm. Includes bibliographical references and index 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 United States Food and Drug Administration United States Food and Drug Administration Drugs Standards United States Medical instruments and apparatus Standards United States Biological products Standards United States Equipment Design standards United States Pharmaceutical Preparations standards United States Biological Products standards United States Device Approval standards United States Equipment and Supplies standards United States Gopalaswamy, Venky Table of contents only http://www.loc.gov/catdir/toc/ecip082/2007043090.html 0 0 0 0 10000 10000 2019-09-04 444.84 0 RM301.27 .G67 2008 0000051278 2019-09-04 00:00:00 1 444.84 2019-09-04 OPEN VIRTUA40 35588 35594 VTLSSORT0080*0200*0201*0400*0900*1000*2450*2600*3000*5040*5050*6100*6101*6500*6501*6502*6503*6504*6505*6506*6507*7000*8560*9991