jag009
★★★

NJ,
2016-05-20 19:26
(2869 d 22:20 ago)

Posting: # 16344
Views: 2,683
 

 What if the References listed drug changed strength? [Regulatives / Guidelines]

Hi all,

If an agency (FDA/EMA or etc) updates the BE guidance to switch the Reference Listed Drug (RLD) to a higher strength, is it possible to claim biowaiver for the higher strength based on proportionality if one already has an approval on the drug product based on BE studies conducted at lower strength RLD -> The previous BE guidance involved a lower strength RLD.

In short, what I am asking is can biowaiver be claimed for higher strength?

Thanks
John
Mauricio Sampaio
★    

Brazil,
2016-05-20 20:56
(2869 d 20:49 ago)

@ jag009
Posting: # 16345
Views: 2,103
 

 What if the References listed drug changed strength?

Hi John!

❝ In short, what I am asking is can biowaiver be claimed for higher strength?


Yes! You can!
Just pay attention if the pharmacokinetics is linear including the higher strength and if there is a proportional similarity in the formulations of all strengths.
jag009
★★★

NJ,
2016-05-20 23:48
(2869 d 17:58 ago)

@ Mauricio Sampaio
Posting: # 16347
Views: 2,064
 

 What if the References listed drug changed strength?

Thank you guys. Now what if approval has not been given but BE studies conducted at the lower strength (old guidance) were successful? Of course, kinetic is linear and formulation is proportional between strengths.

I assume a controlled correspondence is the best bet?

John
nobody
nothing

2016-05-20 21:04
(2869 d 20:41 ago)

@ jag009
Posting: # 16346
Views: 2,119
 

 What if the References listed drug changed strength?

Hi!

Short answer for Europe: Why not? If nonlinearity in PK, it might be necessary to study BE in lowest dose. But read 4.1.6 of the EMA guideline as a whole... ;-)

For US: Hmmmm... better start a controlled correspondence?

Happy weekend everybody!

Kindest regards, nobody
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