Bioequivalence and Bioavailability Forum

Dear HS,

❝ Was it as ‘lively’ as the first Crystal City Conference (people shouting at each other…)?

Well, I wasn't at the first conference so I can hardly compare... Let's say that they disagreed politely (well, quite actively too, when some FDA guys said they wanted long-term stability of the analyte in the samples to be re-demonstrated if a bioanalytical method was transferred from one site to another )

❝ To be honest, I’m not interested in the precision of ‘real-world’ samples, but in their accuracy, which can’t be determinded anyway - simply because we don’t know the true concentration.

❝ It sounds a little bit hypocritical to me- just imagine the situation of a precise but inaccurate measurement, which will would satisfy the FDA, but yield in ‘rubbish’ data…

Actually the summary slides of the 2006 Crystal City meeting used the word "reproducibility" but my understanding is that FDA is concerned with both precision and accuracy. They apparently had some studies with huge (not just 20-30 %) differences between initial and repeated concentrations (e.g. page 2 of the December 2004 http://www.fda.gov/cder/warn/2004/mdsuntitledltr.pdf Letter to MDS Canada. The letter mostly refers to contaminations, but apparently they also had other concerns (there or elsewhere)).

Regards
Ohlbe

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Edit: FDA-link updated for new site structure. [Helmut]