FDA：基于生物药剂学分类系统口服固体速释制剂体内生物利用度与生物等效性研究豁免.pdfVIP

Contains Nonbinding Recommendations Draft — Not for Implementation 34 guidance includes biowaiver extension to BCS class 3 drug products, and additional modifications, 35 such as criteria for high permeability and high solubility. 36 37 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 38 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 39 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 40 the word should in Agency guidances means that something is suggested or recommended, but 41 not required. 42 43 44 II. THE BIOPHARMACEUTICS CLASSIFICATION SYSTE M 45 46 The BCS is a scientific framework for classifying drug substances based on their aqueous solubility 47 and intestinal permeability. When combined with the dissolution of the drug product, the BCS takes 48 into account three major factors that govern the rate and extent of drug absorption from IR solid oral 4 49 dosage forms: (1) dissolution, (2) solubility, and (3) intestinal permeability.According to the BCS, 50 drug substances are classified as follows: 51 52 Class 1: High Solubility –High Permeability 53 Class 2: LowSolubility – High Permeability 54 Class 3: High Solubility –Low Permeability 55 Class 4: Low Solubility –Low Permeability 56 5 57 In addition, some IR solid oral dosage forms are categorized as having rapid or very rapid 58 dissolution. Within this framework, when certain criteria are met, the BCS can be used as a drug