Bioequivalence and Bioavailability Forum

Sample after >85% release [Dissolution / BCS / IVIVC]

posted by Helmut  – Vienna, Austria, 2018-04-29 15:53 (2182 d 20:32 ago) – Posting: # 18740
Views: 10,424

Hi Scopy,

I’m not sure which approach is the ‘correct’ one.

Your last example’s data:

 t      R      T   
 5     32     23   
10     63     44   
14.40  85     51.04
15     88     52   
20     91     65   
25     95     76   
28.46  95.69  85   
30     96     89   
45     97     92   

Highlighted rows at linear interpolated times for 85% release of R and T, respectively.

FDA (1^st time >85% for T at 30 min, one sample after at 45 min): ƒ₁ 21.53, ƒ₂ 34.73
FDA (1^st time >85% for T at 28.46 min, one sample after at 30 min): ƒ₁ 24.95, ƒ₂ 33.16
WHO (1^st time >85% for R at 15 min, one sample after at 20 min): ƒ₁ 32.85, ƒ₂ 30.47
WHO (1^st time >85% for R at 14.40 min, one sample after at 15 min): ƒ₁ 34.97, ƒ₂ 30.19

Quoting the FDA’s guidance:

For curves to be considered similar, ƒ₁ values should be close to 0, and ƒ₂ values should be close to 100. Generally, ƒ₁ values up to 15 (0–15) and ƒ₂ values greater than 50 (50–100) ensure sameness or equivalence of the two curves […]

Can you elaborate how you arrived in this post at an ƒ₂ of 99.5? Just by looking at the curves such a high ƒ₂ does not seem to be possible.

 R   T   Δ    Δ2
32  23   9    81
63  44  19   361
88  52  36  1296
91  65  26   676
95  76  19   361
96  89   7    49
97  92   5    25
         Σ  2849
         n     7

My calculation by including all data showing intermediate results. Note that I simplified the original equa­tion to get rid of the stupid nested brackets:

\(\small{\\
f_2=50\cdot \log_{10}\left \{ \left [ 1+1/n\sum_{i=1}^{i=n}(R_i-T_i)^2\right ]^{-0.5}\cdot 100\right \}=\\
=50\cdot \log_{10}\left ( 100 / \sqrt{1+\sum_{i=1}^{i=n}(R_i-T_i)^2 / n}\right )=\\
=50\cdot \log_{10}\left ( 100 / \sqrt{1+2849 / 7}\right )=50\cdot \log_{10} \left (100/\sqrt {408} \right)=\\
=50\cdot \log_{10} (100/20.199)=50\cdot \log_{10} 4.9507=\\
=50\cdot 0.69467=34.73\; \; \; \; \blacksquare}\)

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• f2 Calculation For Rapidly Dissolving FPPs Obinoscopy 2018-04-22 15:11 
  • Sample after >85% release Helmut 2018-04-22 16:56
    • Sample after >85% release wienui 2018-04-22 21:39
    • Sample after >85% release Obinoscopy 2018-04-23 00:53
      • Sample after >85% release wienui 2018-04-23 03:32
        • Sample after >85% release Obinoscopy 2018-04-24 13:00
          • Sample after >85% release wienui 2018-04-25 18:46
            • Sample after >85% release Obinoscopy 2018-04-27 02:51
              • Sample after >85% release wienui 2018-04-27 03:23
                • Sample after >85% release Obinoscopy 2018-04-28 20:30
                  • Sample after >85% releaseHelmut 2018-04-29 13:53
                    • Sample after >85% release Obinoscopy 2018-04-29 22:08
    • FPP Ohlbe 2018-04-23 11:10
      • FPP Helmut 2018-04-24 00:24
        • FPP JMCardot 2018-05-19 10:12