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A-M-R ☆ Egypt, 2013-02-04 09:34 (4096 d 19:29 ago) Posting: # 9954 Views: 5,270 |
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Request The necessity to do bioequivalence study for sublingual tablets especially isosorbid dinitrate 5mg tablets as it is totally absorbed from oromucosal cavity very thanks Amr hussein |
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The Outlaw Torn ★ Europe, 2013-02-04 09:52 (4096 d 19:11 ago) @ A-M-R Posting: # 9956 Views: 4,567 |
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❝ The necessity to do bioequivalence study for sublingual tablets especially isosorbid dinitrate 5mg tablets as it is totally absorbed from oromucosal cavity Hi Amr, If you are considering an EU submission, this is what the EMA guideline says: Other oral formulations such as orodispersible films, buccal tablets or films, sublingual tablets and chewable tablets may be handled in a similar way as for ODTs. Bioequivalence studies should be conducted according to the recommended use of the product. And, sublingual tablets are not eligible for a BCS-based biowaiver (even if isosorbid dinitrate was highly soluble, highly permeable). It appears you would need to conduct a bioequivalence study if submitting to the EU. Torn |
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drgunasakaran1 ★★  2013-02-06 09:40 (4094 d 19:23 ago) @ A-M-R Posting: # 9972 Views: 4,459 |
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Dear Mr Amr Hussein, ❝ The necessity to do bioequivalence study for sublingual tablets especially isosorbid dinitrate 5mg tablets as it is totally absorbed from oromucosal cavity Even FDA recommends to do Bioequivalence study for ANDA submission of Isosorbide dinitrate sublingual tablets. Reference: FDA Docket No. 77N-0240; DESI 1786 — Dr S Gunasakaran MBBS MD Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same. |
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nobody nothing 2014-11-21 12:33 (3441 d 16:30 ago) @ drgunasakaran1 Posting: # 13905 Views: 3,586 |
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Hi! Found a case of a (nearly) European Agency (UK  ) granting a biowaiver for a chewable tablet, so apparently this type of formulation is considered closer to a conventional IR tablet, from regulatory perspective, although the 2010 EMA guidance on BE considers chewable tablets to be comparable to ODT, for which BE is required...— Kindest regards, nobody |
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