Components of Preclinical Drug Development 450
In Vitro Studies 450
Drug Supply and Formulation 451
In Vivo Studies — Efficacy Testing in Animal
Models 452 In Vivo Studies — Preclinical Pharmacokinetic and
Pharmacodynamic Testing 455 In Vivo Studies — Preclinical Toxicology 455
Drug Development Programs at the NCI 456 History 456
The 3-Cell-Line Prescreen and 60-Cell-Line Screen 456
NCI Drug Development Process 459
The Challenge — Molecularly Targeted
Therapies and New Paradigms for Clinical Trials 459
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