Bioequivalence and Bioavailability Forum • Theoretical carry-over

Theoretical carry-over [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-01-23 20:57 (4537 d 22:54 ago) – Posting: # 12250
Views: 23,817

Hi rezowan,

❝ Why …

Every regulatory agency is free in their decision to state what in their opinion is “sufficient”. HPFB/TGD wants 10×t_½ (<0.1% of theoretical carry-over), ANVISA 7×t_½ (<1% CO), whereas EMA, FDA, and many others are happy with just 5×t_½ (~3% CO).

❝ … washout period is 10 of half life????

Amount remaining = 2^–x and
amount eliminated = 1 – 2^–x,

where x = multiple of half lives passed.

┌────┬──────────────┬─────────────┐

│  x │ remain. (%)  │ elimin. (%) │

├────┼──────────────┼─────────────┤

│  0 │ 100          │  0          │

│  1 │  50          │ 50          │

│  2 │  25          │ 75          │

│  3 │  12.5        │ 87.5        │

│  4 │   6.25       │ 93.75       │

│  5 │   3.125      │ 96.875      │

│  6 │   1.5625     │ 98.4375     │

│  7 │   0.78125    │ 99.21875    │

│  8 │   0.390625   │ 99.609375   │

│  9 │   0.1953125  │ 99.8046875  │

│ 10 │   0.09765625 │ 99.90234375 │

└────┴──────────────┴─────────────┘

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

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Complete thread:

calculation of Washout period bharathnadh.pharma 2014-01-17 09:48
- calculation of Washout period Dr_Dan 2014-01-17 11:48
  - calculation of Washout period Mahesh M 2014-01-17 12:26
    - calculation of Washout period jag009 2014-01-17 17:41
    - calculation of Washout period drgunasakaran1 2014-01-17 17:59
      - calculation of Washout period Mahesh M 2014-01-20 10:46
      - calculation of Washout period rezowan 2014-01-23 19:13
        
        Theoretical carry-overHelmut 2014-01-23 19:57
        
        Theoretical carry-over bharathnadh.pharma 2014-01-25 17:33
  - calculation of Washout period bharathnadh.pharma 2014-01-18 09:45
    - calculation of Washout period drgunasakaran1 2014-01-18 15:37
      - calculation of Washout period bharathnadh.pharma 2014-01-20 05:44
        
        calculation of Washout period Ohlbe 2014-01-20 06:37