Andrew P. Grieve
Safety of Medicines Department, ZENECA Pharmaceuticals
The authors of the recent ICH Draft Tripartite Guidelines on “Dose Response Information to Support Drug Registration” while stressing the need for well-planned prospective experimentation have called for an increasing use of population methods and of “reasoned and well documented exploratory data analysis of existing … databases”. In the light of this it is timely to consider some of the pros and cons of combining information across studies in general and in particular across population studies.
Reference: PAGE 3 (1994) Abstr 877 [www.page-meeting.org/?abstract=877]
Poster: oral presentation