Dictionary of Pharmaceutical Medicine

This dictionary provides definitions of various terms commonly used in pharmaceutical medicine. The newly released edition incorporates updates to meet the increasing regulatory demands, particularly in areas such as genetics/gene therapy, product quality (e.g., protection against counterfeit medicines), and product safety (pharmacovigilance). Additionally, it covers expanding fields, such as cosmetics and dietary supplements, where misleading claims are forbidden but health-related statements require formal approval. These and other areas have been reviewed, updated, and, where necessary, expanded.

The Gospel of St. John states that in the beginning was the Word, and the Word was with God. While this book is no bible, it seeks to bring order to the often chaotic language in the field. New English and German terms have emerged, with meanings as varied as the term CRA (Clinical Research Associate). For example, IRB has been translated into terms like “Institutionelles Aufsichtsgremium,” sometimes with less clarity.

Thus, Dr. Nahler's effort to compile and clarify these terms, abbreviations, and acronyms is highly commendable. Too often, debates arise due to misunderstandings caused by the absence of a reliable reference, one that acknowledges the ambiguity of the terms we use, often assuming universal understanding. Although it may be challenging to use the dictionary in real-time discussions, its continuous use can raise awareness about these issues. Ideally, future writings on the subject will benefit from Dr. Nahler's precise definitions.

I hope this book will be widely used, bringing "aha" moments to many. Given the quality of the content and the constant changes in our field, a new edition, equally comprehensive and engaging, will be required in a few years.

Pharmaceutical medicine, clinical pharmacology, and drug therapy have evolved rapidly in recent years, creating numerous new terms and abbreviations, leaving physicians and pharmacists often needing clarification on their meanings. This confusion arises from the interdisciplinary nature of pharmaceutical medicine, with contributions from specialists across diverse fields. This book is a welcome addition, offering concise and clear information on nearly all relevant topics. It addresses statistics, various branches of clinical pharmacology, issues in clinical drug trials, and pharmacotherapy. While definitions reflect the current state of knowledge, they will need to be continuously updated. 

The dictionary is particularly useful for students of pharmacy and medicine, as well as pharmacists and physicians, serving as a quick and reliable reference. I am confident that this publication will be well-received and widely appreciated.

Pharmaceutical medicine is a multidisciplinary field, encompassing toxicology, pharmacology, statistics, regulatory and legal issues, and more. As a result, additional knowledge is often required beyond one's initial training. Though postgraduate programs are increasing, much of the learning in this field occurs on the job, particularly within the pharmaceutical industry or contract research organizations. Having worked with new colleagues for many years, I recognize the value of a guide that explains the less familiar technical terms and their contexts. This dictionary, containing over 800 keywords, helps users by offering cross-references in small capital letters to highlight related concepts.

Deciding whether to include citations in the dictionary was challenging. There was a strong temptation to reference key publications, especially those from health authorities. However, this would have exceeded the scope of a concise dictionary meant for daily use. It is essential for users to familiarize themselves with the original, comprehensive texts and literature for further study, beyond a collection of citations. To address this, important documents are listed in the appendix of the book. After careful consideration, the decision was made to produce this concise dictionary in its current form.

Like all dictionaries, the information provided must be brief. Furthermore, the field of pharmaceutical medicine is constantly evolving, making it difficult to keep the dictionary both complete and current. This dynamic nature can also result in varying interpretations and uses of the same terms. Readers may interpret some terms differently, so I ask for their understanding and welcome any feedback. Another important aspect is the use of abbreviations. Specialized fields often create their own jargon, and pharmaceutical medicine is no exception. Therefore, a separate index of over 800 frequently used abbreviations is included.

Finally, a directory of important national and international bodies, organizations, and authorities is provided in the appendix, helping users establish contacts and find further information. This dictionary is primarily intended for newcomers to the field or those who encounter pharmaceutical medicine occasionally in their work, such as investigators, pharmaceutical researchers, marketing professionals, or regulatory affairs personnel. However, I hope that experienced professionals working in clinical development will also find the content valuable.

It is impossible to compile such a dictionary without constructive feedback from experienced colleagues and friends. I would like to thank Dr. Dominique B., Dr. Bob Nolan, and Dr. Axel Wenzel for their insightful comments and discussions during the early stages of this project. I also extend my gratitude for the permission to reproduce certain definitions and addresses cited in this book.

ALSO READ: British National Formulary (BNF) 80