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RegisterNTI drug with high CV? [Power / Sample Size]
posted by Helmut 
– Vienna, Austria, 2019-12-14 16:11 – Posting: # 20976
Views: 295
Hi Mikalai,
» What would be a sample size for a BE study when the CV of the drug is 30% but bioequivalence should be in range 90_110%?
Unless the drug belongs to the last generation anticoagulants (dabigatran, rivaroxaban) that's a contradiction. NTIDs show low variability. Otherwise, there would have been serious problems in phase III: toxicity, lacking efficacy – no approval – end of story.
BTW, the acceptance limits for NTIDs in the EEA are 90.00–111.11%.
» Our assumption is around 400 subject if the design is standard, and 200 if the design is replicative
» What would be a sample size for a BE study when the CV of the drug is 30% but bioequivalence should be in range 90_110%?
Unless the drug belongs to the last generation anticoagulants (dabigatran, rivaroxaban) that's a contradiction. NTIDs show low variability. Otherwise, there would have been serious problems in phase III: toxicity, lacking efficacy – no approval – end of story.
BTW, the acceptance limits for NTIDs in the EEA are 90.00–111.11%.
» Our assumption is around 400 subject if the design is standard, and 200 if the design is replicative
library(PowerTOST)
sampleN.TOST(CV = 0.3, theta1 = 0.9, design = "2x2x2")
sampleN.TOST(CV = 0.3, theta1 = 0.9, design = "2x2x4")—
Cheers,
Helmut Schütz
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Cheers,
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- NTI drug but with high CV Mikalai 2019-12-14 15:39 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- NTI drug with high CV?Helmut 2019-12-14 16:11
Ing. Helmut Schütz