3. Detecting and monitoring undesirable effects
Before a molecule can be granted marketing authorization and used in everyday practice, it must satisfy a whole series of scientific and regulatory requirements designed to protect patients. The development of a new drug involves two successive periods, preclinical and clinical, during which the molecule's efficacy and safety are assessed .
3.1 In preclinical studies
Safety conditions are defined by in vitro and animal toxicology...
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Detecting and monitoring undesirable effects
Post-AMM risk monitoring methods
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Bibliography
- (1) - BLAYAC (J.P.) - Regard historique sur la mise en place de la première vigilance française : la pharmacovigilance. - Académie des Sciences et Lettres de Montpellier, 8 fév. 2010 http://www.ac-sciences-lettres-montpellier.fr/academie_edition/fichiers_conf/BLAYAC-2010.pdf ...
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