Hostname: page-component-cd9895bd7-fscjk Total loading time: 0 Render date: 2024-12-27T04:13:39.600Z Has data issue: false hasContentIssue false
  • English
  • Français

Problems of generalization of findings. Regulatory attitudes

Published online by Cambridge University Press:  16 April 2020

U Kern
U Kern*
Affiliation:
Institut für Arzneimittel des Bundesgesundheitsamtes, Seestraβe 10, 13353Berlin, Germany
Get access

Extract

To approve a drug means to release it for use in a specific patient population which should be characterized as clearly as possible in the labelled indications in the Summary of Product Characteristics (eg patients with major depression according to DSM III-R).

Ideally, the patient samples in various clinical trials should be representative of this specific patient population, and the crucial question is whether the study data allow an extrapolation to the wider patient population which we intend to treat.

Basically, what is valid for preclinical data and animal exposure, should also be valid for humans: more or less all regulatory authorities agree that they should accept valid data and information from all regions and all clinical studies available in order to minimize unnecessary human exposures and needless duplication. This is especially important in therapeutic fields where there is an urgent need for treatment due to the lack of suitable alternatives.

Type
Research Article
Information
European Psychiatry , Volume 9 , Issue 3: European Committee for Standardisation of Clinical Trials with Psychotropics, ECST Strasbourg Forum III. 10-11 June 1993, Strasbourg, France , 1994 , pp. 143 - 144
Copyright
Copyright © Elsevier, Paris 1994

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Ansseau, MEditorial: The Atlantic Gap: clinical trials in Europe and the United States. Biol psychiatry 1992:31:1O9–11Google ScholarPubMed
Submit a response

Comments

No Comments have been published for this article.