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Back to the forum  Query: 2017-10-21 03:00 CEST (UTC+2h)

2017-10-04 12:01

Posting: # 17850
Views: 328

 EMA Q&A vs EMA Product Specific guideline [Regulatives / Guidelines]

Dear all,

I would like to know the opinion of the members of the forum about the following point regarding additional modes of administration stated on EMA Q&A on bioequivalence.

According to EMA Q&A on bioequivalence (point 3.6)here if the SmPC of the reference product allows for the possibility to administer the tablet crushed/disintegrated (and dispersed in food), bioequivalence should also be demonstrated, in principle, for a test product with this additional mode of administration.

This point of the Q&A may be confusing and may clash to what is indicated in the product specific quidelines of some products. An example:

-Ticagrelor: SmPC of Ticagrelor indicates that the tablets can be crushed to a fine powder mixed with 1/2 glass of water and administered. It also allows to administer via nasogastric tube. However the Product specific guideline here ask only for fasting study.

Taking into account that Ticagrelor is not BCS class I or III the question is:
Is it supossed a generic should also test these additional modes of administrations (crushed and nasogastric :confused::surprised:)? or, as indicated in the specific guideline a fasting study would be enough?

I have had not checked all Product Specific guidelines but it's possible there could be some other products with a similar situation.

In my opinion this point of EMA Q&A could be the starting point and opens a Pandora's box on new requirements for generics when additional method of administration is stated in the SmPC of the reference. It seems this may lead that for BCS class II or IV the most sensitive method to detect difference in formularion (i.e. fasting/fed, crushed/whole, ...) is not clear for EMA (may always be formulation-dependent) and they are asking to check everything (like they already did for Tadalafil).

What do you think?

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