Français
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 studies. In particular, acute and repeated-dose toxicity studies are used to determine toxic doses and the...
The Ultimate Scientific and Technical Reference
This article is included in
Drugs and pharmaceuticals
This offer includes:
Knowledge Base
Updated and enriched with articles validated by our scientific committees
Services
A set of exclusive tools to complement the resources
Practical Path
Operational and didactic, to guarantee the acquisition of transversal skills
Doc & Quiz
Interactive articles with quizzes, for constructive reading
Detecting and monitoring undesirable effects
Post-AMM risk monitoring methods
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 ...
Websites
http://ansm.sante.fr/ (page consulted on November 26, 2015)
https://ansm.sante.fr/documents/reference/declarer-un-effet-indesirable
Regulations
Laws
Law no. 2011-2012 of December 29, 2011 on reinforcing the safety of medicines and health products
Law no. 98-535 of July 1 1998 on the reinforcement of health monitoring and control of the safety of products intended for human use.
Law no. 95-116 of February 4, 1995 on various social provisions
...
The Ultimate Scientific and Technical Reference
