Guidance for industry
Subtitle: Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
Contributors: Center for Biologics Evaluation and Research (U.S.)
Publisher: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research
Published: 2005
Place of publication: Rockville, MD
Language: eng
Format: [electronic resource] :
Number of pages: 14
Subjects: Biotechnological process monitoring; Pharmaceutical biotechnology; Biological products; International Conference on Harmonisation
Other titles: 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
Notes: Title from title screen (viewed on June 16, 2009).

"ICH".

"June 2005".

Includes bibliographical references (p. 14).

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.