1. The scope of preclinical drug development : an introduction and framework / Mark C. Rogge -- 2. Lead molecule selection : pharmaceutical profiling and toxicity assessments / P.L. Bullock -- 3. Interspecies differences in physiology and pharmacology : extrapolating preclinical data to human populations / M.N. Martinez -- 4. Pharmacokinetics/ADME of small molecules / A.D. Ajavon and David R. Taft -- 5. Pharmacokinetics/ADME of large molecules / R. Braeckman -- 6. Preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development / P.L. Bonate and P. Vicini -- 7. Formulation and production strategies for enhancing bioavailability of poorly absorbed drugs / A.B. Watts and R.O. Williams III -- 8. Transporters involved in drug disposition, toxicity, and efficacy / C.Q. Xia and G.T. Miwa -- 9. Toxicity evaluations, ICH guidelines, and current practice / J.L. Larson -- 10. Application of pathology in safety assessment / Robert A. Ettlin and David E. Prentice -- 11. Utilizing the preclinical database to support clinical drug development / H. Lee.