1. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018 Subject(s): Chemistry, Pharmaceutical -- standardsPharmaceutical Preparations -- standardsBiological Products -- standardsCongresses as TopicDrug ApprovalDrug ContaminationInternational CooperationQuality ControlHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
