Dear Markus, There is a chapter on dose-finding in my book Statistical Issues in Drug Development, Wiley 1997. that has some discussion of issues and references to papers. I personally do not use SAD and MAD as terms and do not think they are standard. I heard them used earlier in the week at the ECPM course in Basle and if any of your colleagues were attending you might like to ask them for notes. Regards Stephen At 13:31 15/07/2004 +0200, Abt, Markus {PDMB~Basel} wrote: >Dear all, > > is anybody aware of statistically oriented articles about SAD and MAD >studies as they are done in early drug development. I would be >interested in (more statistically oriented) articles or books dealing >with any aspect or issues that arise during the planning or conduct >phase of such studies. An internet search just led to case studies, >which is not what I was looking for. My interest is in methodology, whey >are they done the way we do them, what alternative designs are there, >how many pts are really needed etc. > Many thanks in advance for your help. > >Kind regards >Markus Stephen Senn Professor of Statistics Department of Statistics 15 University Gardens <http://www.gla.ac.uk>University of Glasgow G12 8QQ Tel: +44 (0)141 330 5141 Fax: +44(0)141 330 4814 email [log in to unmask] Private webpage: http://www.senns.demon.co.uk/home.html