Birdsong's third law of BE [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2018-06-22 08:10 (858 d 09:38 ago) – Posting: # 18945
Views: 5,665

Hi Beholder,

» I went through the forum but still could not find the information. Ok, we know that it is "highly likely" (;-)) that the EMA took "1/10 or 100 000 rule" from FDA. But why did FDA deside to use 1/10 or 100 000 rule? Why not, for instance, "1/15 and 150 000" or 100 000 is just round number and thats all?

Not actually an answer to your question but a remark. Empirically, in the field of BE it is exceedingly rare that the answer to a question starting with "why?" about guideline requirements will change anything in practice for the person or entity trying to comply.
"Why?", simply stated, often is somewhat founded in frustration or initiates it, but "Why?"" rarely leads to solutions.

Having been a regulator myself, I am aware of all the effort it takes to revise a single sentence in a guideline. What you read in guidelines is the product of science and scientific compromise. The latter is a very significant part of it all. :-)

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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