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7.1 Design of pharmacokinetic studies 194 7.1.1 Alternative study designs for studies in patients 195 7.1.2 Considerations for active pharmaceutical ingredients with long elimination half-lives 195 7.1.3 Considerations for multiple-dose studies 195 7.1.4 Considerations for modified-release products 196 7.2 Subjects 197 7.2.1 Number of subjects 197 7.2.2 Drop-outs and withdrawals 198 7.2.3 Exclusion of subject data 198 7.2.4 Selection of subjects 198 7.2.5 Monitoring the health of subjects during the study 199 7.2.6 Considerations for genetic phenotyping 199 7.3 Investigational product 200 7.3.1 Multisource pharmaceutical product 200 7.3.2 Choice of comparator product 200 7.4 Study conduct 201 7.4.1 Selection of strength 201 7.4.1.1 Non-linear pharmacokinetics 201 7.4.2 Study standardization 201 7.4.3 Co-administration of food and fluid with the dose 202 7.4.3.1即时释放配方202 7.4.3.2修改的释放配方202 7.4.4洗涤间隔203 7.4.5抽样时间203 7.4.6样品液体及其集合204 7.4.7要评估的参数204 7.4.4代谢物研究205 7.4.9统计7.5量化6.5量子206 7. 6 7. 6 7. 6 7. 6 7. 6 7. 6 7. 6 7. 5量子。两阶段顺序设计210 7.7接受范围211 7.8结果报告211 7.9特殊考虑212 7.9.1固定剂量组合产品212 7.9.2生物利用性临床上重要的生物利用性变化213 7.9.3“高度可变的活性药物药物成分” 213
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