EMA Draft Reflection Paper on Dissolution of Oral Generics

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] EMA Published a draft reflection paper in mid-May on dissolution specifications for generic oral immediate release products. The reflection paper discusses suitability of dissolution methods as well as the specifications for oral immediate release generics, with the goal of ensuring batch-to-batch consistency and signaling potential problems. Included in the paper is a proposed decision tree “to make the evaluation process more transparent,” but “there may be some drugs…which still have to be evaluated on a case-by-case basis.”
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