Pilot Results and Pivotal Design [Study Assessment]
Dear unique_one,
I will slightly disagree with Mr. Anand.
As the published literature suggest cv less than 30% and anomalous data are found in your study for 2 subjects. Try evaluating the data excluding this two subjects.
For which regulatory the submission is intended. If it is for USFDA you should consider AUCinf for the sample size estimation based on your presented data (required n=102). Do a literature search if your drug undergo enterohepatic circulation or not? Is the drug product IR formulation and truncation is possible? Is OGD available? Are you talking about deviating from OGD and intend to conduct RASBE study from the data of pilot study?
Based on the presented data GMR of Cmax is close to unity and AUCt is about 93. I don’t think your formulation team may consider reformulating the drug product.
Kindly provide data excluding two subject and reported intraCV in literature for further consideration.
Hope this helps.
Regards,
pjs
I will slightly disagree with Mr. Anand.
As the published literature suggest cv less than 30% and anomalous data are found in your study for 2 subjects. Try evaluating the data excluding this two subjects.
For which regulatory the submission is intended. If it is for USFDA you should consider AUCinf for the sample size estimation based on your presented data (required n=102). Do a literature search if your drug undergo enterohepatic circulation or not? Is the drug product IR formulation and truncation is possible? Is OGD available? Are you talking about deviating from OGD and intend to conduct RASBE study from the data of pilot study?
Based on the presented data GMR of Cmax is close to unity and AUCt is about 93. I don’t think your formulation team may consider reformulating the drug product.
Kindly provide data excluding two subject and reported intraCV in literature for further consideration.
Hope this helps.
Regards,
pjs
Complete thread:
- Pilot Results and Pivotal Design unique_one 2015-10-09 06:44 [Study Assessment]
- Pilot Results and Pivotal Design Anand 2015-10-09 09:04
- Pilot Results and Pivotal Designpjs 2015-10-09 09:57
- HVD sample size d_labes 2015-10-09 13:19
- Pilot Results and Pivotal Design Anand 2015-10-09 09:04