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创新药临床药理学研究技术指导原则
Clinical Pharmacology
NMPA
Updated 2 months ago by Colin Wang
一、前言 临床药理学研究作为创 新药上市前临床研究不可缺失的研究内容可在创新药整体研发策略和各关键时间点,结合临床研究整体进度进行科学合理地研究设计和考虑 。临床药理学研究结果是支持 探索性和确...
化学药创新药临床单次和多次给药剂量递增药代动力学研究技术指导原则
Clinical Pharmacology
NMPA
Updated 2 months ago by Colin Wang
一、前言 药代动力学(Pharmacokinetics,PK)研究旨在阐明药物在体内的吸收、分布、代谢和排泄的动态变化及其规律。创新药临床 PK 研究有助于全面认识人体对药物的处置过程,是推进创...
Leibniz's Notation
Math in Biometrics
Mathematical Analysis
Updated 2 months ago by Colin Wang
Who is Leibniz Gottfried Wilhelm Leibniz (1646 - 1716) was a 17th century German mathematician. H...
First-Order Elimination Kinetics
Math in Clinical Pharmacology
Math in Pharmacokinetics
Updated 2 months ago by Colin Wang
For most drugs, the amount of drug eliminated from the body during any time interval is proportio...