Potency correction - example [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-06-25 12:10 (2524 d 02:19 ago) – Posting: # 18957
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Dear El Maestro,

❝ I still can't, after having read up on this for 8 years, see in which way that opportunity does anything good for the sake of the EU patient.

❝ 90% CI is 77-108 [...]



Now let's take the opposite example: 90% CI is 81-110. Contents: 103% for T, 97% for R. Baseline correction and assay results pre-specified in the protocol. Outcome after correction: the study fails.

Regards
Ohlbe

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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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