« Pharmaceutical Development

The best book I've ever read on design of experiments is "Statistics for Experimenters" by Box, Hunter and Hunter out of the University of Wisconsin Madison.  It doesn't specifically focus on pharma, but has great examples with each chapter - including several that are formulation related.  It was very helpful for me.  Very good exercises to work through as well.

Neal -

If you can provide a little more detail on the stage of the drug development process that is of interest, I may be able to give some suggestions.  There is only a very limited amount of information that would exist in readily citable articles - most is based on regulatory agency guidance documents (i.e. www.fda.gov), formal requirements (generally for safety and clinical studies), but most comes from experience.  General practice and accepted approaches also vary significantly by therapeutic area.  Let me know if there is a particular area of interest (Discovery, PDM, Safety, Clinical) and I'll see what I can send.

  - Mike

Neal -

Plenty of good books on the subject.  One that I used in grad school was: "Design and Analysis of Experiments" by Montgomery).  Also, as Mike said, would also help to know what field within pharma you are interested in using DOE.  For example, I am on the commercial side of Pharma and our use of DOE is often around factorial designs for Conjoint and Discrete Choice modeling.

- John

I have found "Pharmaceutical Experimental Design" by Gareth A Lewis to be a good book.

You would find some more good books on www.Statease.com.

shant  

Mike,

We are working on early stage clinical projects focussing on Phase 1 and early stage Phase 2.  We are developing processes which can be used for scale up work and larger scale production.

Thanks,

Neal

Neal:

The pre-clinical safety requirements and standard Phase I design are pretty well spelled out in the guidance documents the FDA has on its website (www.fda.gov).  If you are planning Phase I to be conducted in volunteers, things are pretty straight forward when you have a clear no-effect dose and a good margin between plasma exposures at that dose and your intended therapeutic concentration.  I hope that is your situation, but my experience is that that rarely is the case.  Some therapeutic areas also have nuances where experience and background in that field come into play (the major service our company offers to its clients).  If you have early concerns about pharmacokinetics or metabolism, you may want to consider an exploratory IND.  It requries less safety information and can be very useful when answers to a few very specific questions are the goal.  If your compound(s) have significant toxicity, but an acceptable risk:benefiit ratio, you may need to begin testing in patients.  This can significantly increase the complexity of your clinical trial design and often gives greater opportunity to assess activity/efficacy earlier.  If you would like to chat in greater detail on specifics, please feel free to contact me off line.

    - Mike