Bioequivalence and Bioavailability Forum • Changing the regulations: Hope dies last.

Changing the regulations: Hope dies last. [NCA / SHAM]

posted by PharmCat – Russia, 2021-10-01 20:48 (1303 d 12:55 ago) – Posting: # 22613
Views: 4,480

❝ Hhm, can you elaborate?

these are my thoughts, I did not support them with any deep search ...
$$C = C_0 * e^{-k_e * t}$$ => $$C = \frac{D}{V_d} * e^{-k_e * t}$$
Model:
$$C = \frac{aX + \epsilon_2}{V_d} * e^{-bZ * t} * \epsilon_1 $$
$$ \epsilon_1 \sim N(0, \sigma_1^2); \epsilon_2 \sim N(0, \sigma_2^2)$$
It can be solved for $a, V_d, b, \sigma_1^2, \sigma_2^2$ and modified for extravascular model.

Something described here: Korkmaz, Selcuk & Orman, Mehmet. (2012). The Use of Nonlinear Mixed Effects Models in Bioequivalence Studies: A Real Data Application. Open Access Scientific Reports. 1-11

However, I think terminal-phase adjusted area under the concentration curve method is something between the classic and NLME approaches. And both of them make corrections for variation from elimination.

Complete thread:

AUC · k for variable inter-occasion CL Helmut 2021-09-30 23:31
- AUC · k for variable inter-occasion CL PharmCat 2021-10-01 00:15
  - Changing the regulations: Hope dies last. Helmut 2021-10-01 11:18
    - AUC * k d_labes 2021-10-01 13:52
      - AUC * k Helmut 2021-10-01 17:01
        
        AUC * k d_labes 2021-10-02 10:55
        
        Ratio/product of two lognormals Helmut 2021-10-03 20:29
        Not for HVDPs? Helmut 2021-10-04 12:05
        
        what about recyclers? mittyri 2021-10-04 14:22
        
        Oh dear! Helmut 2021-10-04 16:10
    - Changing the regulations: Hope dies last.PharmCat 2021-10-01 18:48