Pharmacokinetic metrics CL, Vd and F [Regulatives / Guidelines]
Hi MMW,
This one (page 17)?
If you have a Phoenix/WinNonlin license, please RTFM.
To calculate ƒ (absolute bioavailability after an extravascular dose) you need a crossover study with EV vs. IV doses. Better is simultaneous administration of EV and stable isotope labeled IV – which requires cGMP of the IV dose (that’s a big obstacle). Then
CL and Vd are only accessible after an intravenous dose, where
❝ As per the Guideline, for CFDA submissions, …
This one (page 17)?
F = 100×AUCT/AUCR.
If the drug exhibits linear PK and different doses are administered a correction is suggestedF = 100×(AUCT×DR)/(AUCR×DT).
❝ … pharmacokinetic parameters CL, Vd and F needs to be submitted.
<nitpicking>
pharmacokinetic modeling → PK parameters
noncompartmental analysis → PK metrics
</nitpicking>
❝ Can we calculate these parameters in Phoenix software?
If you have a Phoenix/WinNonlin license, please RTFM.

To calculate ƒ (absolute bioavailability after an extravascular dose) you need a crossover study with EV vs. IV doses. Better is simultaneous administration of EV and stable isotope labeled IV – which requires cGMP of the IV dose (that’s a big obstacle). Then
ƒ = (AUC∞,EV×DIV)/(AUC∞,IV×DEV) and
F (%) = 100ƒ.
CL and Vd are only accessible after an intravenous dose, where
CL = D/AUC∞ and
Vd = D/C0.
- If the study is sufficiently large, ƒ might still be usable though the subjects show extreme variability in PK.
—
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Pharmacokinetic parameters CL, Vd and F mmw 2017-05-06 11:07 [Regulatives / Guidelines]
- Pharmacokinetic metrics CL, Vd and FHelmut 2017-05-06 12:14
- Pharmacokinetic metrics CL, Vd and F Shuanghe 2017-05-08 16:16
- CFDA 2016 BE-GL Helmut 2017-05-09 13:52
- CFDA 2016 BE-GL Shuanghe 2017-05-10 13:03
- nonlinear PK: highest dose ⇔ strength Helmut 2017-05-10 15:17
- highest dose ⇔ strength for dummies d_labes 2017-05-10 15:41
- highest dose ⇔ strength for dummies Helmut 2017-05-10 15:45
- highest dose ⇔ strength for dummies d_labes 2017-05-10 16:20
- highest dose ⇔ strength for dummies Helmut 2017-05-10 16:28
- highest dose ⇔ strength for dummies d_labes 2017-05-11 16:31
- highest dose ⇔ strength for dummies mmw 2017-05-15 06:53
- highest dose ⇔ strength for dummies Helmut 2017-05-10 16:28
- highest dose ⇔ strength for dummies d_labes 2017-05-10 16:20
- highest dose ⇔ strength for dummies Helmut 2017-05-10 15:45
- highest dose ⇔ strength for dummies d_labes 2017-05-10 15:41
- nonlinear PK: highest dose ⇔ strength Helmut 2017-05-10 15:17
- CFDA 2016 BE-GL Shuanghe 2017-05-10 13:03
- CFDA 2016 BE-GL Helmut 2017-05-09 13:52
- Pharmacokinetic metrics CL, Vd and F Shuanghe 2017-05-08 16:16
- Pharmacokinetic metrics CL, Vd and FHelmut 2017-05-06 12:14