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

» 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.

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 [NCA / SHAM]
- 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

- what about recyclers? mittyri 2021-10-04 14:22

- AUC * k d_labes 2021-10-02 10:55

- AUC * k Helmut 2021-10-01 17:01
- Changing the regulations: Hope dies last.PharmCat 2021-10-01 18:48

- AUC * k d_labes 2021-10-01 13:52

- Changing the regulations: Hope dies last. Helmut 2021-10-01 11:18

- AUC · k for variable inter-occasion CL PharmCat 2021-10-01 00:15