The new edition of this successful textbook which started 20 years ago as essential reading for the pharmaceutical physician preparing for the Diploma in Pharmaceutical Medicine reflects the recent changes which have taken place in the complex environment in which the pharmaceutical industry and the pharmaceutical physician operates. This comprehensive volume covers the processes by which medicines are developed, tested and approved. The chapters are written by leading academics, medical directors and legal experts in the field of pharmaceutical medicine and provide authorative and in-depth information for both physicians working in and those who are currently training in the pharmaceutical industry. The material is presented in three parts.
Research and development into new medicines
Regulation of medicines
The healthcare market place
The authors outline the impact which new drug discoveries make on patients' lives and outline the necessarily complex, costly and lengthy pathway towards the delivery of a marketable drug. The authors highlight the modern approach to drug discovery and the changing therapeutic landscape for currently available drugs. The concepts of how medicines should be tested and regulated have also evolved over time and a brief account of some of the major events which have guided drug regulation is provided in this volume. Part III includes an introduction to life cycle management (LCM) in pharmaceuticals which can be defined as maximizing the value of a drug throughout its commercial and development life. It is only in recent years that this term has become a well-known feature of the pharmaceutical industry, as it has started actively applying its principles in the management of medicines in their portfolios. A reduction in the productivity of research and development pipelines and the rising costs of development, increased competition and shortened periods of exclusivity have placed an even greater emphasis on LCM as a means of maximizing the return on investment. Furthermore we live in an era in which the value of medicines can no longer be assumed. With the increasing financial burden on health care systems, the pharmaceutical industry is asked to provide proof of the value of new drugs which are being introduced into the market. It is therefore vital that pharmaceutical physicians understand the basic principles of health economic evaluations in order to work with health economists in the development of high-quality portfolios.
This fully revised seventh edition, which includes two new editors encompasses current developments within pharmaceutical medicine with new topics such as biological therapeutics, vaccines, drugs for cancer, drug development in paediatrics and neonates, pharmacovigilance, the European Clinical trials directive, lifestyle management of medicines, availability of online medicines and counterfeits and the supply of unlicensed medicines. A greater emphasis is given to ethical issues in parts I and III of this edition. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, guidelines and documentation for implementation of clinical trials, relevant European directives and the current syllabus for Pharmaceutical Medicine (PharmaTrain Syllabus 2010).
The scope of this book has broadened over its seven editions and much of the content should now be pertinent to the wide range of personnel involved in the development, regulation and marketing of medicines. The authors have attempted to make this edition a ‘first stop shop’ for those working as clinical trial investigators, their research teams and those working in industry. There is also sufficient referencing provided in each chapter to support further study. The broad international scope will also make this edition of interest to those in the developed and developing markets. This textbook will meet the requirements of both those preparing for the Diploma in Pharmaceutical Medicine and those currently working in the pharmaceutical industry.
Competing Interests
The author has completed the Unified Competing Interest Form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declares no support from any organization for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work.