Principles of Clinical Pharmacology, Third Edition

Book Preface

In the decade since the first edition of Principles of Clinical Pharmacology was published, the discipline of clinical pharmacology has come to play an increasingly important role in drug development and regulatory science, as well as in its continued application to clinical medicine. The third edition remains focused on the principles underlying the development, evaluation, and clinical use of pharmaceuticals. However, recent advances have warranted the inclusion of new chapters on imaging and on the pharmacogenetic basis of adverse drug reactions, as well as a substantial expansion of the scope of the chapters on transporters, pharmacogenetics, and biomarkers.

Since the first edition, the center of gravity of clinical pharmacology as a discipline also has shifted from a primarily academic orientation towards its more practical application by the US Food and Drug Administration (FDA) and the pharmaceutical industry. This is best evidenced by the evolution of the FDA’s Division of Biopharmaceutics into the current FDA Office of Clinical Pharmacology, with the concomitant proliferation of Clinical Pharmacology Guidance documents that are now cited in many chapters of this text. We are indebted to the authors from previous editions who have worked to update their chapters and are delighted to welcome the new authors, several of whom are from the FDA’s Office of Clinical Pharmacology, who have stepped in to contribute both new chapters and new versions of other existing chapters. As in previous editions, the authors in many cases continue to be lecturers in the evening course that has been taught for the past 15 years at the National Institutes of Health (NIH) Clinical Center1. Many of the illustrations in the text appeared originally in Clinical Pharmacology and Therapeutics, and we thank the American Society for Clinical Pharmacology and Therapeutics for allowing us to reproduce these free of charge. Finally, special thanks are due the Elsevier Production Staff who together have provided ongoing support that has been invaluable for the successful production of this book.