Problems with toxicity studies in the assessment of new drugs : Industry and the generation of technology.
The development of new medicines requires a lot of time and the efforts of many researchers.
One of the most taxing parts of this endeavor is the need for long-term toxicity studies in different animals.
This paper describes the development of two different medicines: zimeldine, an antidepressant, and omeprazole, a compound that acts against a specific enzyme in the gastric mucosa that is necessary for the production of gastric acid.
Zimeldine was launched in the international market but had to be withdrawn when it caused severe unexpected adverse reactions.
Omeprazole has been marketed successfully after a prolonged development phase characterized by difficult problems with the toxicity studies.
Mots-clés Pascal : Innovation, Industrie pharmaceutique, Toxicité, Recherche développement, Médicament, Ziméldine, Oméprazole, Animal, Test toxicité, Antidépresseur, Antiulcéreux, Antisecrétoire, Etude cas
Mots-clés Pascal anglais : Innovation, Pharmaceutical industry, Toxicity, Research and development, Drug, Animal, Antidepressant agent, Antiulcer agent, Antisecretory agent, Case study
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Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0581622
Code Inist : 002B30A08. Création : 199406.