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, [2001]
Physical Details
pages 21-115 : digital, PDF file
data file
OCLC
ocn422763158
Title from PDF title page (viewed on July 7, 2009).
"ICH".
"August 2001".
Mode of access: Internet at the FDA web site. Address as of 7/7/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129909.pdf ; current access is available via PURL.