Bioequivalence criteria for study [Regulatives / Guidelines]

posted by Dr.Pravin – Ahmedabad, 2006-12-06 15:17 (6344 d 21:53 ago) – Posting: # 382
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I am conducting one study of highly variable drug for EU, i have defineed the range for the BE limit is 80 to 125% for that drug. The problem is that i have completed the one period of that study, now i want to change the BE criteria, so what is more fesible, protocol deviation or protocol amendment?
—
Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad

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