bioequivalence criteria for NTID [Regulatives / Guidelines]

posted by Biostats – India, 2018-03-30 08:25 (2611 d 03:40 ago) – Posting: # 18623
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Thanks Sir,

Is it mandatory to check - point estimate of the Test/Reference geometric mean ratio must fall within 80.00 - 125.00%?


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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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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