1. 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.
2. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017 Subject(s): Biological AvailabilityDrugs, Investigational -- pharmacokineticsInvestigational New Drug ApplicationTherapeutic EquivalencyAdministration, OralBiopharmaceutics -- classificationDrugs, Investigational -- administration & dosageExcipientsPermeabilityProdrugsSolubilityHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
