生物等效性豁免指南中英对照.pdf

1 GUIDANCE FOR INDUSTRY Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System 基于生物制剂分类系统的速释固体口服制剂 体内生物利用度和生物等效性研究 豁免指 目录 I. INTRODUCTION 引言3 II. THE BIOPHARMACEUTICS CLASSIFICATION SYSTEM 生物制剂分类系统3 A. Solubility 溶解4 B. Permeability 渗透4 C. Dissolution 分解5 III. METHODOLOGY FOR CLASSIFYING A DRUG SUBSTANCE AND FOR DETERMINING THE DISSOLUTION CHARACTERISTICS OF A DRUG PRODUCT 药物分类和制剂溶解特性测定 方法5 A. Determining Drug Substance Solubility Class 判定原料药的溶解度分类5 B. Determining Drug Substance Permeability Class 判定原料药渗透性分类6 1. Pharmacokinetic Studies in Humans 人体内药代动力学研究7 2. Intestinal Permeability Methods 肠道通透性检测方法7 3. Instability in the Gastrointestinal Tract 胃肠道稳定性研究10 C. Determining Drug Product Dissolution Characteristics and Dissolution Profile Similarity 测定药 物的溶解特性和溶解相似性11 IV. ADDITIONAL CONSIDERATIONS FOR REQUESTING A BIOWAIVER 生物豁免请求其他注意 事项12 A. Excipients 辅料12 B. Prodrugs 药物前体13 C. Exceptions 不适用情况13 1. Narrow Therapeutic Range Drugs 治疗范围狭窄的药品13 2. Products Designed to be Absorbed in the Oral Cavity 口腔吸收制剂13 V. REGULATORY APPLICATIONS OF THE BCS BCS 的申请13 A. INDs/NDAs 13 B. ANDAs 14 C. Postapproval Changes 批准后变更14 VI. DATA TO