Bioequivalence and Bioavailability Forum

"FDA acceptable" software or code to calculate bootstrap F2? [Dissolution / BCS / IVIVC]

posted by sameep – India, 2015-01-07 07:08 (3756 d 04:29 ago) – Posting: # 14233
Views: 25,712

❝ 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.

Dear Friends,
There is an option in DDSolver to calculate bootstrap F2. The results obtained using DDSolver and PhEq_Bootstrap are coming different.

Sample DDSolver results:
Observed f2 - 41.690
Number of bootstrap - 10000
Bootstrap mean - 40.393
Bootstrap median - 40.416
5% percentile - 34.344
95% percentile - 46.290
Is 5% percentile > 50 - No
Similarity of R and T - Reject

Sample PhEq_Bootstrap results:
Number of bootstrap - 10000
Average F2 - 40.34
F2 unbiased value - 42.46
Expected F2 - 38.62
Lower confidence interval for expected f2 - 33.42
Upper confidence interval for expected f2 - 43.62
Similarity NOT confirmed: Lower CI is below the limit (f2 = 50)

Now the question is, which one of the two software's perform "FDA acceptable" calculation?
Here, i am assuming that "Shah VP, Tsong Y, Sathe P, Liu JP. In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2. Pharm Res. 1998 Jun;15(6):889-96." method is "FDA acceptable".

OR is there any other method to calculate the bootstrap F2 (I am no SAS brainer )?
If SAS can be used, does any one have the code for it?

Thanks in advance,
Sameep

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 method yjlee168 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