Bioequivalence and Bioavailability Forum • FDA prefer bootstrap f2 to MSD method

FDA prefer bootstrap f2 to MSD method [Dissolution / BCS / IVIVC]

posted by yjlee168 – Kaohsiung, Taiwan, 2013-06-16 00:17 (4406 d 08:29 ago) – Posting: # 10803
Views: 29,343

Dear all,

Helmut recently introduced a free open-source program called "PhEq_bootstrap". Please see this thread. I don't know if this program fits your needs or not.

Program description from SOURCEFORGE:

This program was developed as a help in establishing pharmaceutical equivalence by use of FDA f2 coefficient. It was designed to help with f2 computation in cases when intra- and inter-batch variability is large, namely RSD>10%. The use of statistical bootstrap technique allows to implement confidence interval (CI) into the f2 coefficients resulting in overcoming of their major drawback in the original metrics. The algorithm provides possible “worst case scenario” of f2 values, thus supporting claim about pharmaceutical equivalence. The target users are researchers from industry and academia dealing with pharmaceutical equivalence problem....

—
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

Complete thread:

FDA prefer bootstrap f2 to MSD method Shuanghe 2013-06-14 10:55
- bootstrap f2 in R d_labes 2013-06-14 13:48
  - Off-topic Helmut 2013-06-14 14:30
  - bootstrap f2 in R Shuanghe 2013-06-14 15:13
    - bootstrap f2 in SAS d_labes 2013-06-14 15:55
- FDA prefer bootstrap f2 to MSD methodyjlee168 2013-06-15 22:17
  - "FDA acceptable" software or code to calculate bootstrap F2? sameep 2015-01-07 06:08
- FDA prefer bootstrap f2 to MSD method AngusMcLean 2013-06-18 16:06
  - R-package for bootstrapping f2? d_labes 2013-06-19 08:20
    - R-package for bootstrapping f2? AngusMcLean 2013-06-19 21:51
      - Bootstrapping f2 in Pascal d_labes 2013-06-20 08:18
        
        source code is available? ElMaestro 2013-06-20 12:45
        
        Yes, source code is available yjlee168 2013-06-20 13:21
        
        Bootstrapping f2 in Pascal AngusMcLean 2013-06-20 15:29
        Bootstrapping f2 in Pascal AngusMcLean 2013-06-22 00:47
        
        OT Helmut 2013-06-22 02:57
        
        OT AngusMcLean 2013-06-22 15:57