This book has been divided into five parts: History and Basic Principles (Chapters 1–4); In Vitro/Pre-Clinical (Chapters 5–7); Clinical Pharmacology (Chapters 8–16); Biopharmaceutics (Chapters 17–20) and Contemporary and Special Interest Topics (Chapters 21–25).
The first part of this book introduces the reader to regulatory history, important regulations governing clinical pharmacology and biopharmaceutics portion of the new drug application, and the review process at the Food and Drug Administration (FDA). This is followed by a part in-vitro and preclinical studies such as metabolism, drug-drug interactions, transporters and interspecies scaling. Part III introduces the reader to clinical pharmacology studies that are generally conducted. This part starts with a chapter on analytical method validation, and takes the reader through characterization of basic pharmacokinetics properties to surrogate markers, population PK and PD studies, and assessment of in-vivo drug interactions. Three chapters in this part discuss special populations like disease state for example (renal and hepatic impairment), gender, race, age (elderly and pediatric), pregnancy, and lactation. The last chapter in Part III discusses clinical pharmacology issues related to several specific drug classes.
Clinical pharmacology is followed by a part on biopharmaceutics. This part starts off with a chapter on bioavailability and bioequivalence (BA/BE) assessments for new and generic drugs followed by chapters on oral extended release products, and when and how one can obtain a waiver for conducting in-vivo BE studies. The last chapter in this part describes the assessment of BE of drugs administered via routes other than oral.
The chapters in this book are the result of expertise and time devoted by many experts from the FDA and other regulatory agencies. In addition to the scientific principles, the authors were encouraged to include key points from the latest regulatory guidances. Further, authors have attempted to include the regulatory requirements from other (European, Canada) agencies and also incorporate ICH (International Conference on Harmonization) requirements. There are 25 chapters written by 40 authors in this book. Author have made every attempt to use the same format and terminology and avoid duplication of information. However, since this book is aimed to be used as a teaching tool, some duplicated information was deliberately left untouched for the sake of completeness of a chapter.
This book is intended to serve as an introductory reference text to the pharmaceutical scientist, student, and researcher involved in the new drug development. This book is not intended to be used as a template, but gives the reader basic understanding of the drug development process for a new chemical being developed as a drug.
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