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.
2. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017 Subject(s): Drug ApprovalDrug ContaminationParticulate MatterPharmacopoeias as Topic -- standardsCongresses as TopicInternational CooperationHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
3. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018 Subject(s): Antineoplastic Agents -- therapeutic useClinical Trials as TopicDrug Evaluation, PreclinicalAntineoplastic Agents -- toxicityDrug ApprovalDrug ContaminationResearch DesignToxicity TestsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
