Abstract
This article reviews the process by which new drugs are introduced into anaesthetic practice with particular emphasis on pharmaceutical development and government regulation. After a brief overview of the drug development process, new trends in drug development are discussed including implementation of pharmacokinetic, pharmacodynamic and toxicokinetic studies in both preclinical and human phases of drug evaluation. A synopsis of the drug regulatory process is provided and, in particular, the problem of unapproved drug use in anaesthesia is discussed. Ethical issues regarding physician-industry interactions are highlighted by examples of conflict of interest in anaesthesia. The processes of drug development and regulation require much effort and cooperation between clinicians, pharmaceutical manufacturers and government regulators to achieve a common goal; the development and utilization of safe and effective drugs. A fundamental understanding of these processes may farther facilitate optimal drug utilization and the active involvement of anaesthetists in the drug development process.
Résumé
Cet article passe en revue les mécanismes qui précèdent l’introduction de nouveaux produits pharmaceutiques en anesthésie, et plus particulièrement, sur leur développement et la réglementation gouvernementale qui s’y applique. Après un bref survol des mécanismes engagés dan l’élaboration d’un produit, les nouvelles directives qui régissent le développement des nouveaux agents sont discutées dont l’mplémentation d’études pharmacocinétiques, pharmacodynamiques et toxicocinétiques pendant les phases précliniques et humaines de l’évaluation. Un résumé des mécanismes de la réglementation est présenté et, en particulier, les problèmes entraînés par l’utilisation de drogues non approuvées pour l’anesthésie. Les problèmes d’éthique propre aux interelations médecin-industrie sont aussi discutés avec des exemples de conflits d’intérêt s’appliquant à l’anesthésie. Les processus de développement et de réglementation des drogues requièrent beaucoup d’efforts et de collaboration entre cliniciens, manufacturiers et intermédiaires gouvernementaux pour atteindre un objectif commun: le développement et l’utilisation de produits efficaces et ne présentant que peu de risques. Une compréhension de ces processus peut favoriser l’utilisation optimale des drogues et la participation active des anesthésistes à leur développement.
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Gilron, I. The introduction of new drugs into anaesthetic practice: a perspective in pharmaceutical development and regulation. Can J Anaesth 42, 516–522 (1995). https://doi.org/10.1007/BF03011691
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DOI: https://doi.org/10.1007/BF03011691