CBB
☆    

India,
2019-01-30 13:06
(1706 d 06:50 ago)

Posting: # 19827
Views: 2,459
 

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

Post reply
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
★★  

Russia,
2019-02-01 00:28
(1704 d 19:28 ago)

@ CBB
Posting: # 19836
Views: 2,027
 

 Simulations?

Post reply
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
 
UA Flag
Activity
 Admin contact
22,764 posts in 4,776 threads, 1,628 registered users;
16 visitors (0 registered, 16 guests [including 9 identified bots]).
Forum time: 20:56 CEST (Europe/Vienna)

The object of statistics is information.
The objective of statistics is the understanding of information
contained in data.    Irwin and Marylees Miller

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5