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Hi HS,
And that too in fasting condition.
I am now more worried about the variability in fed condition where there will be more variables (different gastric pHs, different gastric emptying rate, different gastric moment). Innovator has not done the fed study but FDA want generics company to do both the studies (here)
With this variability, does it really makes a sense to run a pilot study using 18-24 volunteer?? As there will be no gurantee that a product formula comfortable in pilot will pass again in pivotal studies.
Or one shall simplay go ahead with the exhibit batches and take a rist with higher number of volunteers?
Tough times ahead.
❝ Absolutely. These are the highest numbers I ever have seen. BTW, AUC > Cmax…
And that too in fasting condition.
I am now more worried about the variability in fed condition where there will be more variables (different gastric pHs, different gastric emptying rate, different gastric moment). Innovator has not done the fed study but FDA want generics company to do both the studies (here)
With this variability, does it really makes a sense to run a pilot study using 18-24 volunteer?? As there will be no gurantee that a product formula comfortable in pilot will pass again in pivotal studies.Or one shall simplay go ahead with the exhibit batches and take a rist with higher number of volunteers?
Tough times ahead.
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Case Study (FDA) Helmut 2014-09-30 13:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Case Study (FDA) jag009 2014-09-30 17:25
- Case Study (FDA) Helmut 2014-09-30 20:09
- Case Study (FDA)luvblooms 2014-10-01 06:24
- Case Study (FDA) Helmut 2014-10-01 14:32
- Case Study (FDA)luvblooms 2014-10-01 06:24
- Case Study (FDA) luvblooms 2014-10-01 06:15
- Case Study (FDA) jag009 2014-10-01 20:41
- Case Study (FDA) Helmut 2014-09-30 20:09
- Case Study (FDA) jag009 2014-09-30 17:25
Ing. Helmut Schütz