Integrated Summaries and Meta-Analyses in Clinical Drug Development

Integrated summaries of safety and efficacy have long been used for regulatory purposes in clinical drug development, where the main objective is to summarize the results of a drug development program as outlined in the International Conference on Harmonization (ICH) E9 guideline. Curiously, the use...

Full description

Saved in:
Bibliographic Details
Published in:Drug information journal 2002, Vol.36 (1), p.127-133
Main Authors: Kübler, Jürgen, Weihrauch, Thomas R.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Medical sciences
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Integrated summaries of safety and efficacy have long been used for regulatory purposes in clinical drug development, where the main objective is to summarize the results of a drug development program as outlined in the International Conference on Harmonization (ICH) E9 guideline. Curiously, the use of meta-analytical techniques seems to be restricted to the submission process and little use of cumulative data is made for life cycle management of drugs. In this paper, we will explore options for a comprehensive approach to support the development, registration, and life cycle management of pharmaceuticals for human use.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286150203600116