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Dear All,
Please, could anyone provide me a explanation:
EMEA IC90% to bioequivalence studies is 70 - 143% or 75 - 133%? Some
articles consider 70 - 143% but EMEA guidance says 75 -133%. So, why
do someone consider 70 - 143% ?
Regards,
Daniel R. Campos
Brazil
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Mostly Confidence interval limits based on safety and efficacy of the
humans. Once you study the different countries guidelines then you will
get to know appropriate answer.
Srisesrinivas
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