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.
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