yuvaneshwari
☆    

India,
2019-01-23 06:09

Posting: # 19801
Views: 454
 

 BCS II waiver approach [Dissolution / BCS / IVIVC]

Dear All,

Drug compound is BCS-II [dosage form is solution filled in capsule], and objective is to formulate with Q1 & Q2 sameness to that of Reference. Since API is in solution state filled in capsule, its solubility/bioavailability is improved tremendously.

In the above scenario, can we consider for BCS based waiver approach ?
Ohlbe
★★★

France,
2019-01-27 18:18

@ yuvaneshwari
Posting: # 19813
Views: 306
 

 No way

Dear yuvaneshwari,

» Since API is in solution state filled in capsule, its solubility/bioavailability is improved tremendously.

» In the above scenario, can we consider for BCS based waiver approach ?

I think you have answered your own question. If solubility is the limiting factor, and your product has an improved solubility compared to the reference, how could you justify any kind of biowaiver ?

In any case: BCS-based biowaivers are only possible for class I and III products. Not the slightest chance if you're dealing with class II or IV.

Regards
Ohlbe
yuvaneshwari
☆    

India,
2019-01-28 05:16

@ Ohlbe
Posting: # 19815
Views: 280
 

 No way

Thanks for your response. I was hoping to justify the waiver on the basis of sameness of finished test product against reference. I understand that criticality still remain since the molecule is BCS II drug. Thank you.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
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