CLiR No. 3 - Human beings, Ethics, and Clinical Research

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WHERE DRUGS AND MEDICINES COME FROM A BRIEF ACCOUNT OF THE DEVELOPMENT OF PHARMACEUTIC AL S Arieh Roldán Mercado Sesma

Summary According to data from the pharmaceutical industry, of every 10,000 molecules evaluated for transformation into some kind of medicine, only one to three of them will make the grade. The development of pharmaceuticals is a continuous and changing process, with different byways and nuances whereby the search for a molecule or substance with pharmacological potential, whatever its origin, goes through various phases of testing for safety and effectiveness, leading finally to a drug for human consumption.

Introduction A probability of one in ten thousand would be acceptable to almost no one. In simple human terms (and not mathematical ones) it would mean possibly waiting almost twenty-seven years to find a solution to a problem, if you tried out a new solution every day. You might have to read 9,999 books before finding your favorite author or the precise quotation that describes your emotions. The same number of television series might be necessary for you to say you like one of them. And yet this is the kind of probability that a drug or medicine has of eventually being marketed. According to data from the pharmaceutical industry, of every 10,000 molecules evaluated for transformation into some kind of medicine, only one to three of them will

make the grade. During the process, some of them will lose viability in the first stage, and others perhaps when they are nearly ready for sale to the public. Still others will achieve their goal of being marketed, but in real-life circumstances they will end up being withdrawn for reasons of safety or owing to various commercial considerations.1

CLINICAL RESEARCH & PHARMACOLOGY

is a surgeon and obstetrician graduated from the Universidad de Guadalajara. He studied at the Centro Universitario from 2000 to 2006, earning a master’s degree and doctorate in pharmacology. He has been an associate professor and researcher at the Centro Universitario de Tonalá (Universidad de Guadalajara) since 2012 and is a member of the Sistema Nacional de Investigadores (Level 1).


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