Bioequivalence and Bioavailability Forum

Hi HS,

❝ Good question. I think we are pushing software to the limits, i.e.,

❝ running into troubles of getting a rasonable value of the noncentral

❝ t-distribution (numeric precision,...).

❝ Fartssie comes up with -0.0278 (!), StudySize 2.01 simply gives up (-,

❝ with 20 subjects/sequence gives 0.421%), and (blah blah blah)

I actualy meant this as a trick question. As you correctly point out this is, even with advanced and trusted software, not an exact science. While mathematicians may say that a problem (such as power in a BE study) has this and that exact solution and be pointing at some ridiculously complex integrals, many of such problems are solved numerically today. Integration is a typical example, it requires some Al Gore Rhythms which are heavily parameterised. Robustness is all about finding the set of parameters that give a consistent answer, but we can sometimes find condititions where the algorithm fails or miscalculates. The figures above illustrate it. Thus we might ask further: Under which conditions will Software X give me an answer that is 5% wrong? That is one helluva difficult question to answer when exact solutions are not available to compare with.

EM.