biowaiver for higher strength [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-01-24 15:09 (112 d 04:05 ago) – Posting: # 22753
Views: 851

HI Dshah,

» Interesting question but when we revisit guidelines, the biowaiver recommendation is mostly for lower strength formulation only. I believe that the criteria of not using higher strength due to safety/AE if justifiable, then may be used to support waiver using lower strength.

According to the guidance it seems possible.
"For an NDA, biowaivers of a higher strength will be determined to be appropriate based on (1) clinical safety and/or efficacy studies including data on the dose and the desirability of the higher strength, (2) linear elimination kinetics over the therapeutic dose range, (3) the higher strength being proportionally similar to the lower strength, and (4) the same dissolution procedures being used for both strengths and similar dissolution results obtained. A dissolution profile should be generated for all strengths."


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