Guidance for industry : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
- Additional Titles:
- Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process and Comparability of biotechnological/biological products subject to changes in their manufacturing process
- Published:
- Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
- Physical Description:
- 1 online resource (14 pages)
- Additional Creators:
- Center for Drug Evaluation and Research (U.S.) and Center for Biologics Evaluation and Research (U.S.)
Access Online
- Restrictions on Access:
- Free-to-read Unrestricted online access
- Report Numbers:
- HE 20.4702:B 52/2
- Subject(s):
- Note:
- Title from title screen (viewed on June 16, 2009).
"ICH".
"June 2005". - Bibliography Note:
- Includes bibliographical references (page 14).
- Technical Details:
- Mode of access: Internet at the FDA web site. Address as of 6/15/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128076.pdf ; current access is available via PURL.
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