Ahmed Al Habashi
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UAE,
2014-10-20 14:09
(3469 d 08:49 ago)

Posting: # 13753
Views: 2,294
 

 ODF (Oral Dispersible Films)-BE [Regulatives / Guidelines]

Do health authorities accept registration of ODF (Oral Dispersible Films) comparing the BE with tablets or capsules?
Helmut
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Vienna, Austria,
2014-10-20 15:08
(3469 d 07:50 ago)

@ Ahmed Al Habashi
Posting: # 13756
Views: 1,876
 

 ODF (Oral Dispersible Films)-BE

Hi Ahmed,

welcome to the forum. Please follow its Policy (especially #1, #2) in the future. THX.

❝ Do health authorities accept registration of ODF (Oral Dispersible Films) comparing the BE with tablets or capsules?


See f.i. EMA’s BE-GL, Appendix II.

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