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CLINICAL PHARMACOLOGY 2003 (PART 5)

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Preclinical drug development. Discovery of new drugs in the laboratory is an exercise in prediction • Techniques of discovery. Sophisticated molecular modelling allows precise design of potential new therapeutic substances and new technologies have increased the rate of development of potential medicines. Studies in animals and in humans Prediction. Failures of prediction occur and a drug may be abandoned at any stage, including after marketing. New drug development is a colossally expensive and commercially driven activity. ...
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CLINICAL PHARMACOLOGY 2003 (PART 5) 3 Discovery and development of drugs SYNOPSIS the agent will do to man. Medicinal therapeutics rests on the two great supporting pillars of • Preclinical drug development. Discovery of pharmacology: new drugs in the laboratory is an exercise in prediction • Selectivity: the desired effect alone is obtained; • Techniques of discovery. Sophisticated We must learn to aim, learn to aim with molecular modelling allows precise design of chemical substances (Paul Ehrlich).2 potential new therapeutic substances and • Dose:.. .The dose alone decides that something new technologies have increased the rate of is no poison (Paracelsus).3 development of potential medicines. For decades the rational discovery of new • Studies in animals and in humans medicines has depended on modifications of the • Prediction. Failures of prediction occur and a molecular structures of increasing numbers of known drug may be abandoned at any stage, natural chemical mediators. Often the exact molecu- including after marketing. New drug lar basis of drug action is unknown, and this book development is a colossally expensive and contains frequent examples of old drugs whose commercially driven activity. • Orphan drugs and diseases. 1 In this chapter we are grateful for permission from Professor Sir Colin Dollery to quote directly and indirectly from his Harveian Oration, Medicine and the pharmacological revolution (1994) Journal of the Royal College of Physicians of London 28: 59-69. 2Preclinical drug Paul Ehrlich (1845-1915), German scientist who pioneered the scientific approach to drug discovery. The 606th organicdevelopment arsenical that he tested against spirochaetes (in animals) became a successful medicine (Salvarsan 1910); it and a minor variant were used against syphillis until superseded by penicillin in 1945. Pharmacology and medicinal chemistry have transformed 3 Paracelsus (1493-1541) was a controversial figure who has medicine from an intellectual exercise in diagnosis into a been portrayed as both ignorant and superstitious. He had powerful force for the relief of human disease (CT Dollery no medical degree; he burned the classical medical works 1994) (Galen, Avicenna) before his lectures in Basel (Switzerland) and had to leave the city following a dispute about fees with a prominent churchman. He died in Salzburg (Austria) eitherThe development of new medicines (drugs) is an as a result of a drunken debauch or because he was thrownexercise in prediction from laboratory studies in down a steep incline by hitmen employed by jealous localvitro and in vivo (animals), which forecast what physicans. But he was right about the dose. 41 3 DISCOVERY AND DEVELOPMENT OF DRUGSmechanism of action remains mysterious. The evol- (chemistry, biochemistry, pharmacology), andution of molecular medicine (including recombinant an overall lack of understanding of howDNA technology) in the past 20 years has led to a physiological and pathophysiological processesnew pathway of drug discovery: pharmacogenomics.4 contribute to the interaction of drug andThis broad term encompasses all genes in the disease.genome that may determine drug response, desired ...

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