Research Catalog

Guidance for industry Q3B(R2) impurities in new drug products.

Title
Guidance for industry [electronic resource] : Q3B(R2) impurities in new drug products.
Publication
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006]

Available Online

http://purl.access.gpo.gov/GPO/LPS113762

Details

Additional Authors
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Biologics Evaluation and Research (U.S.)
  • International Conference on Harmonisation.
Description
8 p. : digital, PDF file.
Alternative Title
  • Q3B(R2) impurities in new drug products
  • Impurities in new drug products
Subject
  • Drug development > Government policy > United States
  • Drug adulteration > Government policy > United States
Note
  • Title from PDF title page (viewed on June 15, 2009).
  • "ICH".
  • "July 2006".
  • "Revision 2".
System Details (note)
  • Mode of access: Internet at the FDA web site. Address as of 6/15/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128033.pdf ; current access is available via PURL.
Call Number
GPO Internet HE 20.4702:IM 7/2
OCLC
399838071
Title
Guidance for industry [electronic resource] : Q3B(R2) impurities in new drug products.
Imprint
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006]
System Details
Mode of access: Internet at the FDA web site. Address as of 6/15/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128033.pdf ; current access is available via PURL.
Connect to:
http://purl.access.gpo.gov/GPO/LPS113762
Added Author
Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
International Conference on Harmonisation.
Gpo Item No.
0499-T (online)
Sudoc No.
HE 20.4702:IM 7/2
Research Call Number
GPO Internet HE 20.4702:IM 7/2
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