Bioequivalence and Bioavailability Forum • Sample size calculation for Ophthamal Drug

MGR
★

India,
2014-10-09 15:07
(4273 d 06:49 ago)

Posting: # 13678
Views: 6,215

Sample size calculation for Ophthamal Drug [Power / Sample Size]

Dear All,

We are trying to do a BE Study with Clinical Endpoint for an Suspension/Drops, Ophthalmic.

Could anybody please suggest what are the parameters to be taken to calculate a sample size for this type of study?

For example please find the below link for a drug name and the type of study:

BE study with clinical end point

Moreover, Please give reference if any guideline on Ophthalmic drugs for USFDA or EMEA regulatory.

Thanks in advance.

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Regards,
MGR

ElMaestro
★★★

Denmark,
2014-10-09 15:31
(4273 d 06:26 ago)

@ MGR
Posting: # 13679
Views: 4,973

Sample size calculation for Ophthamal Drug

Post reply

Hi MGR,

❝ Could anybody please suggest what are the parameters to be taken to calculate a sample size for this type of study?

❝

❝ For example please find the below link for a drug name and the type of study:

❝

❝ BE study with clinical end point

You are going to need intra-ocular pressure as your endpoint. To get a sample size, first define your statistical model. Then perhaps find some actual values to use here.

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Pass or fail!
ElMaestro