Guidance for industry [electronic resource] : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
- Bib ID:
- 4658401
- Format:
- Book
- Online Access:
- http://purl.access.gpo.gov/GPO/LPS113768
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- Description:
-
- 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]
- 14 p. : digital, PDF file.
- 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.
- Notes:
-
- Title from PDF title page (viewed on June 16, 2009).
- "ICH".
- "June 2005".
- Includes bibliographical references (p. 14).
- Subject:
- Other authors/contributors:
- Also Titled:
-
- Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
- Comparability of biotechnological/biological products subject to changes in their manufacturing process
- Govt. Doc. Number:
- HE 20.4702:B 52/2
- Copyright:
-
In Copyright
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- Reason for copyright status:
- Until 2075 [Created/Published Date + 70 Years]
Copyright status was determined using the following information:
- Material type:
- Literary Dramatic Musical
- Published status:
- Published
- Publication date:
- 2005
Copyright status may not be correct if data in the record is incomplete or inaccurate. Other access conditions may also apply. For more information please see: Copyright in library collections.
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