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jag009 ★★★ NJ, 2016-05-20 19:26 (3687 d 15:04 ago) Posting: # 16344 Views: 3,999 |
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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 |
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Mauricio Sampaio ★ Brazil, 2016-05-20 20:56 (3687 d 13:34 ago) @ jag009 Posting: # 16345 Views: 3,152 |
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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. |
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jag009 ★★★ NJ, 2016-05-20 23:48 (3687 d 10:43 ago) @ Mauricio Sampaio Posting: # 16347 Views: 3,074 |
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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 |
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nobody nothing 2016-05-20 21:04 (3687 d 13:26 ago) @ jag009 Posting: # 16346 Views: 3,155 |
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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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