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

posted by dshah  – India/United Kingdom, 2023-08-01 14:36 (61 d 16:04 ago) – Posting: # 23691
Views: 616

(edited by on 2023-08-01 15:43)

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.


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