Linearity [Regulatives / Guidelines]
Hi John,
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) ?
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) ?
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
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- biowaiver for higher strength jag009 2022-01-24 15:09
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- biowaiver for higher strength jag009 2022-01-24 15:09
- LinearityOhlbe 2022-01-24 12:16
- Linearity jag009 2022-01-24 15:06
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- biowaiver for higher strength dshah 2022-01-24 11:01