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临床前药物开发 107条(本栏目收费,不能显示细节,电话13136136841)
2.Utilizing the Preclinical Database to Support the Efficacy Claim for Regulatory Approval ....557
557
3.Utilizing Preclinical Database to Address Safety Concerns ....559
559
4.Utilizing the Preclinical Database to Design In Vivo Metabolic Drug–Drug Interaction Studies ....561
561
1.The Scope of Preclinical Drug Development: An Introduction and Framework .......1
1
Mark C.Rogge References ....8
8
2.Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical Data to Human Populations ........11
11
Marilyn N.Martinez 1.Overview ....11
11
2.Toxicology Tests: Points to Consider ....12
12
3.Toxicological Endpoints ....13
13
4.Factors that Can Influence Study Results ....15
15
5.Interspecies Pharmacokinetic Differences ....22
22
7.Concluding Thoughts ....55
55
3.Transgenic Animals for Preclinical Drug Development ...............67
67
Li-Na Wei 1.Introduction ....67
67
2.Production of Transgenic Animals ....68
68
3.Applications in Preclinical Drug Development ....83
83
4.The Prospective ....89
89
4.Pharmacokinetics/ADME of Small Molecules ..........99
99
Vangala V.Subrahmanyam and Alfred P.Tonelli 1.Introduction ....99
99
2.Pharmacokinetics: General Overview ....100
100
3.Mechanisms of Small Molecule Absorption ....101
101
4.Mechanisms of Small Molecule Distribution ....110
110
5.Mechanisms of Small Molecule Metabolism ....113
113
6.Mechanisms of Small Molecule Excretion ....136
136
7.Small Molecule ADME: Issues for Drug Development ....140
10
8.Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling of Preclinical Data ....145
145
9.Conclusions ....147
147