第1章 生物药剂学概述.pdfVIP

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● 生物药剂学与药物动力学 药剂学教研室 孙维彤 1 The Long Road to a New Medicine 申请证书 上市 II期临床试验 III期临床试验 临床前安 全有效性 I期临床试验 候选化 药物制剂 合物 设计 合成 筛选 初步安全有 靶标的确定 效性研究 新药研究与开发的历程 ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Processes of New Drugs ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Medicinal chemistry; Pharmacology; biopharmaceutics; Biochemistry Pharmacokinetics Idea Chemical lead biological characteristics Preformulation studies Formulation studies pharmaceutics Biopharmaceutics Clinical pharmacology; pharmaceutics Clinical pharmaceutics Preclinical and clinical studies 4 ● ● ● ● ● ● ● ● ● ● ●