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As editors of the second edition of Preclinical Drug Development, we are pleased to present this updated text on the science of safely moving therapeutic candidates into, and through, clinical development. In the few years since we published the first edition, additional understanding and establishment of new technologies for preclinical evaluation have occurred. For this reason, this edition has been published. Readers of this edition will find updated and expanded chapters covering key content areas that include pharmaceutical profiling and lead molecule selection, interspecies differences in physiology and pharmacology affecting extrapolation to humans, pharmacokinetics (ADME) of both small and large molecules, pharmacokineticpharmacodynamic modeling and simulation of preclinical data, role of membrane transporters on drug disposition, toxicity evaluations, application of pathology in safety assessment …