Mauricio Sampaio
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Brazil,
2020-07-13 13:52
(716 d 04:20 ago)

Posting: # 21683
Views: 959
 

 Requirements for different pharmaceutical forms or dosages [Regulatives / Guidelines]

Dear, what is the guideline from EMA that I would found the bioavailability requirements for different pharmaceutical forms or dosages?
For example, comparing tablet vs suspension (with same dosage), extende release vs immediate release, tablet 500 mg vs tablet 250 mg (with same drug).

Thank you for any help!
Helmut
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Vienna, Austria,
2020-07-13 17:25
(716 d 00:47 ago)

@ Mauricio Sampaio
Posting: # 21690
Views: 752
 

 Homework ;-)

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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