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q8

q8

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Published by: kvcchakrapani on Mar 28, 2010
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07/26/2010

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Guidance for Industry
Q8 PharmaceuticalDevelopment
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)May 2006ICH
 
 
Guidance for Industry
Q8 PharmaceuticalDevelopment
 
 Additional copies are available from:Office of Training and Communication Division of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573http://www.fda.gov/cder/guidance/index.htmOffice of Communication, Training and  Manufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448http://www.fda.gov/cber/guidelines.htm.
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)May 2006ICH
 
 
TABLE OF CONTENTSI.
 
INTRODUCTION (1, 1.1)................................................................................................1
 
II.
 
PHARMACEUTICAL DEVELOPMENT (2)...............................................................2
 
A.
 
Components of the Drug Product (2.1)........................................................................................3
 
1.
 
 Drug Substance (2.1.1)....................................................................................................................3
 
2.
 
 Excipients (2.1.2).............................................................................................................................4
 
B.
 
Drug Product (2.2).........................................................................................................................4
 
1.
 
Formulation Development (2.2.1)....................................................................................................4
 
2.
 
Overages (2.2.2)..............................................................................................................................5
 
3.
 
Physicochemical and Biological Properties (2.2.3)........................................................................5
 
C.
 
Manufacturing Process Development (2.3)..................................................................................6
 
D.
 
Container Closure System (2.4)....................................................................................................7
 
E.
 
Microbiological Attributes (2.5)...................................................................................................7
 
F.
 
Compatibility (2.6).........................................................................................................................8
 
III.
 
GLOSSARY (3).................................................................................................................9
 

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