1. Regulatory classification of pharmaceutical co-crystals Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018 Subject(s): Chemistry, Pharmaceutical -- classificationChemistry, Pharmaceutical -- standardsCrystallization -- classificationInvestigational New Drug ApplicationBiological AvailabilityHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018 Subject(s): Drug Compounding -- standardsLiposomes -- chemistryLiposomes -- pharmacokineticsBiological AvailabilityChemistry, PharmaceuticalLiposomes -- administration & dosageLiposomes -- therapeutic useHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.