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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)
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