The United States of America
AAPS Advances in the Pharmaceutical Sciences Series（2017）
关键词
Active pharmaceutical ingredient (API), Acceptance criteria, Area under the curve (AUC), Bioavailability (BA), Bioequivalence (BE), C-max, Confidence interval (CI), Elimination rate constant, Essentially similar, European medicines agency (EMA), Extravascular, Fixed-dose combination (FDC), US food and drug administration (FDA), Guidelines, Guidances, Multisource (generic) pharmaceutical product, Mutual recognition procedure (MRP), Pharmaceutical alternatives, Pharmacodynamic, Pharmacokinetic, Dosage form, Pharmaceutical equivalence (PE), Proportionally similar dosage forms, Regulations, Therapeutic equivalence(TE), T-max, Topical, Vasoconstrictor assay (VCA)
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