Cover Image

Guidance for industry : Q1A(R2) stability testing of new drug substances and products.

Bibliographic Details
Corporate Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), International Conference on Harmonisation
Format: Government Document Conference Proceeding eBook
Language:English
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, [2003]
Subjects:
Drug stability.
Drugs > Testing.
Online Access:https://purl.fdlp.gov/GPO/LPS113798
Description
Item Description:Title from PDF title page (viewed on June 16, 2009).
"ICH".
"November 2003".
"Revision 2".
Electronic resource.
Physical Description:i, 22 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA web site. Address as of 6/16/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128204.pdf ; current access is available via PURL.
Bibliography:Includes bibliographical references (page 21).