1. E6(R2) good clinical practice: integrated addendum to ICH E6(R1) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Subject(s): Clinical Trials as Topic -- ethicsClinical Trials as Topic -- methodsEthics Committees, ResearchInformed ConsentRandomized Controlled Trials as Topic -- ethicsRandomized Controlled Trials as Topic -- methodsResearch DesignResearch SubjectsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018 Subject(s): Clinical Trials as Topic -- ethicsDrug Compounding -- standardsPediatricsPharmaceutical PreparationsChildExcipientsInfantInfant, NewbornInternational CooperationModels, TheoreticalPharmaceutical Preparations -- administration & dosageTasteHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
