临床前药物开发 107条(本栏目收费,不能显示细节,电话13136136841)
10.Toxicity Evaluations: ICH Guidelines and Current Practice .........349 349
Jeffrey L.Larson 1.Chapter Overview ....349 349
2.Introduction ....350 350
3.ICH Non-Clinical (Preclinical) Toxicity Guidelines ....354 354
4.Additional Safety Topics and Guidelines ....379 379
5.Non-Clinical Development Programs ....383 383
6.Conclusions ....409 409
11.Application of Pathology in Safety Assessment ........415 415
Robert A.Ettlin and David E.Prentice 1.Introduction ....415 415
2.Technical Post-Mortem Procedures ....430 430
3.General Pathology ....442 442
4.Typical Non-Neoplastic Alterations Seen in Toxicity Studies ....458 458
5.Typical Neoplastic Changes Seen in Life-Time Bioassays ....491 491
6.Investigation of Unclear Pathological Findings ....498 498
7.Interpretation of Pathological Findings ....499 499
9.Conclusions ....507 507
12.Principles of Toxicogenomics: Implications for Preclinical Drug Development ..........531 531
Ju rgen Borlak 1.Introduction ....531 531
2.Transcript Profiling ....531 531
3.Methological Considerations ....532 532
4.Gene Expression Profiling—Practical Considerations ....541 541
5.Case Study: Elucidation of Teratogenic Mechanism(s) of Toxicity of a Developmental Drug, EMD 82571 ....542 542
6.Turning Data into Knowledge ....548 548
13.Utilizing the Preclinical Database to Support Clinical Drug Development ..........551 551
Howard Lee 1.Utilizing the Preclinical Database to Select Human Dose ....552 552