Dissolution profile comparision-Pharmaceutical industry

Hi Please include the options for the calculation of the following for dissolution profile comparison(requirement of  regulatory agencies)

a. F2

b. boot strap F2

c.Multivariate model dependent

d. Multivariate model independent 

 

This should help the people in pharma domain to use JMP more effectively.

 

 

 

Tracking Number:

Defect ID: S1570317

2 Comments
Staff

Yes! this would be great.

 

Would you mind posting some links to this thread.

-a link to the Guidance for Industry

-a link to one of the FDA talk slide decks where the basic concepts are explained

 

 

Level II

Hi,

Please consider the formulas reported on page 8 of the following oficial guidance document.

https://www.fda.gov/media/70936/download

and scientific paper: https://link.springer.com/article/10.1023/A:1011976615750

 

There is a lot of scientific paper on this subject.