Abridged application for modified release forms [Regulatives / Guidelines]

posted by Jignesh S Kotecha – India, 2019-05-12 18:53 (803 d 21:42 ago) – Posting: # 20280
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We are developing a prolonged release tablet for Europe market. This product has got single strength. The therapeutic doses is achieved with this single strength by increasing the number of tablets per day in three divided doses. These doses should be attained slowly, by step-wise increase by one tablet every two weeks.

We are required to conduct a single dose fasting, single dose fed and multiple dose study in fed condition. Since this product has single strength and dose is increased to therapeutic level step-wise, can we conduct the multiple dose study at given strength considering it as a sensitive strength?


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