Clinical pharmacology medicine development

WILLIAM M. WARDELL (Clinical Pharmacology, Medicine) is Associate Professor of Pharmacology and Toxicology and Director of the Center for the Study of Drug Development at the University of Rochester. 

The overall objective of clinical trials is to establish a drug therapy that is safe and effective in humans, to the extent that the risk-benefit relationship is acceptable. The ICH process has developed an internationally accepted definition of a clinical trial as Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. ... 

Once a decision has been made to develop a compound further following the extensive pre-clinical pharmacological and toxicological studies, approval for the first clinical studies must be sought from the regulatory authority (Medicines Board in Europe or the Food and Drug Administration in the USA). A clinical trial of a new drug is, in the words of Bradford Hill (in his Principles of Medical Statistics) ... 

Suryawati S. Contribution of clinical pharmacology to improve the use of medicines in developing countries. Int J Risk Saf Med 2005 17 57-64. 

The present short overview of medicines regulation is clearly not comprehensive but rather an attempt to give idea about the complexities of this important area of work that has many direct links with clinical pharmacology. Clinical pharmacologists as medical specialists equipped with unique knowledge about medicines have a role and responsibility to develop and contribute to medicines regulation. 

Medicine. He served on a number of Royal College of Physicians London Working Parties including that on the Development of Clinical Pharmacology and Therapeutics in a Changing World . 

Coplan PM, Noel RA, Levitan BS, Ferguson J, Mussen F. Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines. Clinical Pharmacology and Therapeutics 2010 89(2) 312-315. 

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