Research Catalog

Guidance for industry Q1E evaluation of stability data.

Title
Guidance for industry [electronic resource] : Q1E evaluation of stability data.
Publication
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, [2004]

Available Online

http://purl.access.gpo.gov/GPO/LPS113795

Details

Additional Authors
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Biologics Evaluation and Research (U.S.)
  • International Conference on Harmonisation.
Description
18 p. : digital, PDF file.
Alternative Title
  • Q1E evaluation of stability data
  • Evaluation of stability data
Subject
Drug stability > Testing
Note
  • Title from PDF title page (viewed on June 16, 2009).
  • "ICH".
  • "June 2004".
Bibliography (note)
  • Includes bibliographical references (p. 17).
System Details (note)
  • Mode of access: Internet at the FDA web site. Address as of 6/16/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128122.pdf ; current access is available via PURL.
Call Number
GPO Internet HE 20.4702:ST 1
OCLC
401360575
Title
Guidance for industry [electronic resource] : Q1E evaluation of stability data.
Imprint
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, [2004]
System Details
Mode of access: Internet at the FDA web site. Address as of 6/16/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128122.pdf ; current access is available via PURL.
Bibliography
Includes bibliographical references (p. 17).
Connect to:
http://purl.access.gpo.gov/GPO/LPS113795
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:ST 1
Research Call Number
GPO Internet HE 20.4702:ST 1
View in Legacy Catalog