Bioequivalence and Bioavailability Forum • multiple dosage study

multiple dosage study [Regulatives / Guidelines]

posted by Mahesh M – India, 2016-08-18 14:50 (3133 d 02:44 ago) – Posting: # 16560
Views: 7,522

Dear All,

For EMA submission of prolonged release dosage form is it possible to Waiver for multiple dosage study on the basis of evidence of “lack of accumulation (by SPC, PAR or literature) and the provide partial AUC for both fasting and fed two way study as supportive?

Regards

Complete thread:

multiple dosage studyMahesh M 2016-08-18 12:50 [Regulatives / Guidelines]
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