Homework ;-) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-07-13 17:25 (469 d 10:59 ago) – Posting: # 21690
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Hi Mauricio,

see also this post #3.

» For example, comparing tablet vs suspension (with same dosage), …

Both are immediate release formulations. Hence, the BE-GL (details in APPENDIX III).

» … extende release vs immediate release, tablet 500 mg vs tablet 250 mg (with same drug).

MR-GL Section 5. Note that this is not the generic pathway but a hybrid application (you would additionally need clinical studies). See section 5.2 for the ‘exceptional cases’ where they might be waived. Personally I haven’t see one so far.

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Helmut Schütz
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