Linearity [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-01-24 16:06 (309 d 17:07 ago) – Posting: # 22752
Views: 1,254

Hi Ohlbe,

❝ Does your drug show linear PK ? If not: does it show more-than-proportional increase (then the highest strength would be more sensitive to show differences in BA) or less-than-proportional increase (lowest strength would be more sensitive, giving you good arguments) ?

Yes its linear PK. I read the FDA guidance about Guidance, for NDA it seeems "possible" as long as one can provide safety and efficacy data.


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