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RegisterHomework ;-) [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2020-07-13 19:25 (1612 d 20:28 ago) – Posting: # 21690
Views: 1,507
Hi Mauricio,
see also this post #3.
Both are immediate release formulations. Hence, the BE-GL (details in APPENDIX III).
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.
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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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Requirements for different pharmaceutical forms or dosages Mauricio Sampaio 2020-07-13 13:52 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Homework ;-)Helmut 2020-07-13 17:25
Ing. Helmut Schütz