Pilot Results and Pivotal Design [Study Assessment]
Dear All,
Kindly find the brief summary of below mentioned results for one of the pilot studies conducted. n=16, 2 way 2 period 2 treatment single dose crossover.
As per the literature the molecule does not have iscv above 30% and therefore we need to design our pivotal study accordingly.
Can you let us know your feedback on the below mentioned:
unique_one.
Edit: Category changed. [Helmut]
Kindly find the brief summary of below mentioned results for one of the pilot studies conducted. n=16, 2 way 2 period 2 treatment single dose crossover.
Parameter Ratios CI 90_L CI 90_U Power IS CV (%)
Ln(Cmax) 98.58 77.47 128.41 0.4194 43.13
Ln(AUC last) 93.86 82.05 110.32 0.8307 22.51
Ln(AUC INF) 89.75 72.47 111.56 0.5223 33.65
As per the literature the molecule does not have iscv above 30% and therefore we need to design our pivotal study accordingly.
Can you let us know your feedback on the below mentioned:
- Can we proceed with the pivotal study by considering the above results of pilot study?
- Cmax and AUC inf are showing ISCV above 30%. Therefore what could be the conclusion for same?
- As per the ratios of test/reference, are their any evaluations required with respect to formulation.
- There are 2 subjects data out of 14 in which the concentration data is quite anomalous and not matching with the rest of the 14 subjects data. Would this be the reason for higher ISCV of Cmax and AUC Inf?
- If we go by considering the above results for pivotal, what could be the design and an approximate sample size?
unique_one.
Edit: Category changed. [Helmut]
Complete thread:
- Pilot Results and Pivotal Designunique_one 2015-10-09 06:44 [Study Assessment]
- Pilot Results and Pivotal Design Anand 2015-10-09 09:04
- Pilot Results and Pivotal Design pjs 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