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India,
2019-01-30 12:06

Posting: # 19827
Views: 780
 

 Sample Size calculation for ophthalmic PK endpoint study [Power / Sample Size]

How to calculate sample size for pivotal ophthalmic PK endpoint study (having Only one single sample of aqueous humor is collected from one eye of each patient) which bootstrapping techniques are utilized for final BE conclusion...??? :confused:
mittyri
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Russia,
2019-01-31 23:28

@ CBB
Posting: # 19836
Views: 631
 

 Simulations?

Hi,

if you don't have analytical solution - look for simulations approach :-D
Simulate the data using known distribution parameters, desired sample size and then use bootstrap technique for evaluation. Repeat it ad-hoc (until the success/failure ratio stabilizes). Then change the sample size and repeat until desired power is reached. Don't forget about SciAdv.

Kind regards,
Mittyri
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