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THE PHARMA REVIEW (NOVEMBER 2009)

Drug Research: Chances and Risks Involved in the Development of New Drugs

Ravinder Kaul

Abstract: The development of a new drug is a mammoth project. It can take up to 15 years, involves hundreds of researchers, and costs several hundred million dollars. It begins with the process of finding a target in human body that causes a specific disease. In many cases these are proteins. Intellectual flexibility, team spirit and a willingness to learn are important factors for the successful research and development of a new drug.

Introduction
Next to atomic and space research, development of drugs at the present time is the most expensive and demanding enterprise in the economy. The development of a new drug costs the companies 400 million dollars and in the world more than five thousand million dollars are set aside annually for this research. The companies carrying out this research calculate about 10 to 12 percent of their turnovers for these expenses. This cost is increasing and in the course of the last ten years alone has roughly quadrupled, the increase being due not only to higher costs of personnel and materials, but also to the more expensive trials and controls necessary in the light of the latest scientific knowledge as well as due to stricter new drugs laws and regulations. Unfortunately, this has not led to an increase in the yield of new drugs in the last 10 years but rather to a decrease.
 
From whence then does the idea for a new drug come? What deliberations lead to new developments? How are ideas from chemistry and biology put into practise? What is the procedure for testing new drugs in animals and humans in order to arrive at the highest possible benefit for man under a maximum of safety, and finally what are the difficulties which may, right up to the last moment, cross the path of a new product and obstruct it? Unfortunately, it is only too rare that the theoretical ideas obtaining at the beginning of the development of a new drug later prove to be correct. Even today, chance too often has a hand in the game, chance in a scientific laboratory (penicillin, furosemide), in a chemical factory (prednisolone, streptomycin) or by the sickbed (oral antidiabetics, chlorpromazine). It is mostly substances resulting from the chemist’s synthetic work or possibly also substances of interest from the point of view of patent rights that must be examined and tested for their hypothetical effect. But naturally a very important incentive in our research is the knowledge of a disease, of a medical indication for which there is still no effectively useful medicament available. 

 

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