Preface

After graduating in pharmaceutics and joining a multinational pharmaceutical company, I quickly realized how much I need to learn about drug development and the associated regulatory process. Most pharmaceutical scientists have gained knowledge of regulatory science from practical experience. There is not a single textbook that combines scientific and regulatory principles essential to answering the clinical pharmacology and biopharmecutics questions that arise during drug development. Motivated by the lack of such a book, I compiled this text. This book is aimed at students and new scientists in the industry and government, and at encouraging universities to incorporate training for regulatory sciences in their curriculum.

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.

There are certain situations in drug development which require additional consideration. For example, the development of a chiral drug, liposomal drug product, or drugs to treat situations/illnesses created by biological and nerve poisoning agents. The last part of this book discusses such contemporary or special topics. The last chapter in this book is a tutorial in conducting statistical analysis of BE studies.

The FDA and other regulatory agencies continue to release guidances on contemporary topics. For example, when this book went in to print, guidances on pharmacogenomics/pharmacogenetics and assessment of QTc prolongation by drugs were still being developed. This book is by no means exhaustive and the reader is encouraged to refer to the regulatory agency websites on these ever-evolving contemporary topics.

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. I 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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