1. Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018 Subject(s): Chemistry, PharmaceuticalDrug LiberationSolubilityDosage FormsTherapeutic Index, DrugHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Quality attribute considerations for chewable tablets Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018 Subject(s): Chemistry, PharmaceuticalDrug LiberationMasticationQuality ControlSolubilityTablets -- pharmacokineticsDrug ApprovalDrug LabelingHardnessTherapeutic EquivalencyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.