Clinical end point acceptance limit [Study As­sess­ment]

posted by PKS – India, 2019-04-05 09:17 (772 d 13:50 ago) – Posting: # 20128
Views: 2,330

» » Should I conclude bio-equivalence with the values of [-0.2025, 0.076] in clinical end point study. Can I assume it as within the interval of (-0.20, 0.20)
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» What does your protocol say on exactly that matter?

My protocol says within (-0.20 and 0.20)

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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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