Drug development overview

M. Mathieu, New Drug Development A. Begulatory Overview, Parexel, Waltham, Mass., 1994. 

This volume gives an overview of the current status and an outlook to future more reliable predictive approaches. It is subdivided in five sections dealing with studies of membrane permeability and oral absorption, drug dissolution and solubility, the role of transporters and metabolism in oral absorption, computational approaches to drug absorption and bioavailability, and finally with certain drug development issues. 

Lever (1987) presents an excellent overview of the regulatory process involved in FDA oversight of drug development, and gives the historical perspective for the evolution of the conservative process that is designed to ensure that any new pharmaceutical is both safe and efficacious. 

The first edition1 of this book was published approximately 13 years ago. Its primary objective was to present an overview and a "roadmap" of the process of new drug discovery and development, particularly oriented to individuals or companies entering the pharmaceutical field. It was written by one of the authors (Smith), with no contributors, and drawn on Smith s experiences in the industry and field over the course of nearly 40 years. In the second edition, the scope of the first book has been expanded and technical details in the form of hard data have been included. In addition to the editors own commentary and contributions, the major part of the book is the result of contributions of experts in the industry. New chapters on risk assessment, international harmonization of drug development and regulation, dietary supplements, patent law, and entrepreneurial startup of a new pharmaceutical company have been added. Some of the important, basic operational aspects of drug discovery and development (e.g., organizational matters, staff requirements, pilot plant operations, etc.) are not repeated in this book but can be found in the first edition. 

Gosse, M.E., Manocchia, M., and Nelson, T.F., Overview of US Pharmaceutical Development, 1980-1994, Tufts University Center for the Study of Drug Development, May, 1996. Grabowski, H.G. and Vernon, J., The search for new vaccines the errors of the vaccines for children program, American Enterprise Institute, Washington, 1994. 

Pharmacokinetics and toxicity have been identified as important causes of costly late-stage failures in drug development. Hence, physicochemical as well as ADMET properties need to be fine-tuned even in the lead optimization phase. Recently developed in silica approaches will further increase model predictivity in this area to improve compound design and to focus on the most promising compounds only. A recent overview on ADME in silica models is given in Ref [128]. 

Proper and comprehensive planning of a clinical trial is essential to the successful development of any drug. Clinical trial design is a subject whose scope is too broad to be undertaken in this text, and only a brief overview of the subject is presented below. The interested reader is referred to the Further Reading section at the end of this chapter. The general principles presented below are relevant to phase II, and particularly phase III, clinical trials. As the bulk of the estimated 300-500 million required to develop a drug is spent on clinical trials, a poorly planned and/or executed clinical trial can be very costly to the drug developer. 

Nations Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments. WHO publishes updates to this list Pharmaceuticals Restrictions in use and availability. WHO publishes also quarterly WHO Drug Information (http //www.who.int/druginformation/) journal which provides an overview of topics of current relevance relating to drug development, safety and regulation. Latest lists of proposed and recommended International Nonproprietary Names (INN) for Pharmaceutical Substances are also published in this journal. 

For readers familiar with biotechnology, biopharmaceutics, and the drug development process, and for those that focus on the application of biopharmaceuticals. Part II provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail for each FDA approved, recombinantly derived biopharmaceutical, and several other interesting therapeutic proteins, for each category of macromolecule... 

Overview of the Pharmaceutical Industry An FDA-Industry Dialog on the Drug Development Process... 

Mathieu, M. New Drug Approval in the United States. Worldwide Pharmaceutical Regulation Series. Waltham, MA PAREXEL International, 1998. Mathieu, M. New Drug Development A Regulatory Overview, rev. 3rd ed. 

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