Lionel D Edwards1 and Anthony W Fox2

1Basking Ridge, NJ, and 2EBD Group Inc, Carlsbad, CA, USA

This section of the book is concerned about the events that must take place in the conversion of a drug into a medicine that can be approved by regulatory authorities. It is important to know what does and does not comprise these events.

First, the chapters here may be regarded loosely as the premarketing phases of a successful drug's life cycle. This not congruent with the whole of drug development. What is needed to get a drug approved is not the same as what is needed to make that drug into a commercial success.

Second, the overall emphasis here is clinical development, how this is done, and what preclinical information is needed in order to carry it out. Necessarily, we have here had to be general, and these chapters are mostly written to describe, and assist with, typical development issues. However, for some disciplines, this is impossible; for example, there is little preclinical pharmacology in this section, since this discipline is really product-specific. In contrast, the general principles of toxicology (for example), and what the pharmaceutical physician needs to know about toxicology before starting any clinical trial, may be usefully stated in the general case.

Third, while some clinical developers erroneously view regulatory affairs as the implementation of their clinical development plans (and probably vice versa), the proper constraints imposed by regulatory authorities are so fundamental that they deserve a section to themselves (see Section III). However, we would emphasize that this division is artificial in comparison to how real drugs get developed, which requires intimate coordination of clinical development with regulatory compliance. Similarly, the financial and legal underpinnings of the drug development process are described in later sections of this book, but are constraints that constantly govern the thinking of the good pharmaceutical physician during clinical development.

Fourth, the chapters on Phase I clinical trials and pharmacoeconomic research have been written by experts in these fields. These are very rapidly-developing disciplines. The typical pharmaceutical physician has usually paid little attention to these aspects of clinical development, but it is our belief that these will dictate his/her clinical development plans to an ever-increasing degree in the future. Phase I studies can shorten overall clinical development time, and the pharmacoeconomic leveraging of (especially) Phase III and Phase IV studies (with preparatory Phase II work) are now essential in the modern competitive environment.

The integration of the activities described in these chapters is essential to good clinical development. Some cross-referencing and overlap between these chapters is deliberately included to emphasize such integration. Pharmaceutical physicians, specialized though they may be in one discipline or another, are well-advised to keep an observant eye on the interactions between their own and other company departments. Experience is probably the best teacher of integration. But we hope these chapters convey some idea.

0 0

Post a comment