Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers
- Series Title(s):
- Guidance for industry
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
- Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
- Chemistry, Pharmaceutical -- standards Pharmaceutical Preparations -- standards Biological Products -- standards Congresses as Topic Drug Approval Drug Contamination International Cooperation Quality Control Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Guideline Technical Report
- The National Library of Medicine believes this item to be in the public domain. (More information)
- 1 online resource (1 PDF file (14 pages))
- NLM Unique ID:
- 101734070 (See catalog record)