Bioequivalence and Bioavailability Forum • Sample after >85% release

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

posted by Helmut – Vienna, Austria, 2018-04-22 18:56 (2555 d 19:26 ago) – Posting: # 18719
Views: 12,516

Hi Scopy,

❝ […] a situation where a test product is rapidly dissolving (>85% in 30 mins) while the comparator product is very rapidly dissolving (>85% in 15 mins) and vice versa. Is f2 calculation necessary? If it is, which time points will be used?

Tricky. ƒ₂ is generally not required if product(s!) release ≥85% in all three media. In the calculation of ƒ₂ the devil is in the details. There are different restrictions on samples after 85% release:

FDA
Only one measurement included for test product.
EMA
Not more than one mean value for each formulation.
WHO
Maximum of one time-point of the reference product.

Hence, bad luck for the EMA. For the FDA and the WHO, it depends.

BTW, what is an FFP?

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Complete thread:

f2 Calculation For Rapidly Dissolving FPPs Obinoscopy 2018-04-22 15:11 [Dissolution / BCS / IVIVC]
- Sample after >85% releaseHelmut 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% release Helmut 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