yuva
☆    

2023-08-01 13:23
(292 d 03:53 ago)

Posting: # 23690
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 BCS class I (dispersible tablet): selection of reference product [Regulatives / Guidelines]

Dear All,

A BCS class I molecule is formulated as an immediate release tablet and is intended to be dispersed in a glass of water at the time of administration. The dispersed tablet will not be completely dissolved at the time of patient intake. Kindly do not conclude it as an effervescent tablet and there is no reference product available in market with similar features to be selected as a comparator for this ANDA filing.

Having said that, will it be acceptable to select an "oral solution" from the market as a reference and opt for "Solution based waiver" approach?
Will the regulatory agencies accept this idea? If yes, what can be the maximum volume (250mL is the best to consider) and maximum duration of time to consider for generating in-vitro data to establish sameness between Test and Reference?

Thanks in advance
Yuva
dshah
★★  

India/United Kingdom,
2023-08-01 14:36
(292 d 02:41 ago)

(edited by on 2023-08-01 15:43)
@ yuva
Posting: # 23691
Views: 1,529
 

 BCS class I (dispersible tablet): selection of reference product

Hi Yuva!

❝ Having said that, will it be acceptable to select an "oral solution" from the market as a reference and opt for "Solution based waiver" approach?


Mostly this is 505(b)(2) approach and bridging study is required IMHO.

❝ Will the regulatory agencies accept this idea? If yes, what can be the maximum volume (250mL is the best to consider) and maximum duration of time to consider for generating in-vitro data to establish sameness between Test and Reference?


Mostly solution vs dispersible tablet study might be required.

Regards,
Divyen
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