Bioequivalence and Bioavailability Forum

Hi ElMaestro,

❝ this was a great post, and really a necessary one.

THX.

❝ a. "Noone has proven it doesn't work so we'll try it."

Courageous (or just stupid?)

Primary concern in bioequivalence assessment is to limit the risk of erroneously accepting bio­equi­va­lence, i.e., maintain the patient’s risk (α) at ≤0.05.^1,2 Only statistical procedures, which do not exceed the nominal risk of 5%, can be accepted.^3,4

❝ I have heard that there is going to be a symposium in Prague in two weeks where one of the true authorities on the issue of two-stage approaches (I am talking about a certain consultant from Vienna who also has a nasty habit of torturing statistical software) is a panelist…

I have heard that another eminent consultant from Haderslev (having the habit of coding nasty software) will be a panelist as well.

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Oldies but goodies:
1. McGilveray IJ, Midha KK, Skelly JP, Dighe S, Doluisio JT, French IW, Karim A, Burford R. Consensus Report from ‘Bio International ’89’: Issues in the Evaluation of Bioavailability Data. J Pharm Sci. 1990;79(10):945–6. doi 10.1002/jps.2600791022
   
2. Melander H. Problems and Possibilities with the Add-On Subject Design. In: Midha KK, Blume HH. (eds). Bio-International. Bioavailability, Bioequivalence and Phar­ma­co­kinetics. Stuttgart: medpharm; 1992; p. 85–90.
   
3. Commission of the European Communities. CPMP Guideline: Investigation of Bioavailability and Bioequivalence. Brussels 1991;111/54/89_EN. online
   
4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials. E9 (Step 4, 1998) online