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Evaluation of safety and side effects in the process of anti-anxiety drug development *

Published online by Cambridge University Press:  16 April 2020

M Bourin ,
A Couetoux du Tertre  and
R Payeur
M Bourin
Affiliation:
Laboratoire de Pharmacologie, Faculté de Médecine et GIS Médicament, 44035Nantes, France
A Couetoux du Tertre
Affiliation:
Laboratoire de Pharmacologie, Faculté de Médecine et GIS Médicament, 44035Nantes, France
R Payeur
Affiliation:
Centre Hospitalier Pierre Janet, 20, rue Pharand, Hull J9A 1K7, PQ, Canada
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Summary

As with other drugs it is necessary to look for changes induced by anxiolytics on vital signs, laboratory parameters and adverse events. In return, in a more specific way for anxiolytics, we will look at side effects at the central nervous system level with psychological and physiological battery tests. We will also assess the safety of use of anxiolytics in certain specific conditions, such as overdose or withdrawal and in certain populations such as the elderly, neonates and children. The assessment of safety and side effects, whatever the drug type studied, must come early in the developing process of a drug (phases I, II and III).

Keywords

side effectsanxiolytics
Type
Methodology
Information
European Psychiatry , Volume 8 , Issue 6 , 1993 , pp. 285 - 291
Copyright
Copyright © Elsevier, Paris 1993

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