highest dose ⇔ strength for dummies [Regulatives / Guidelines]
Dear Helmut,
If somebody creates a 300 mg tablet / capsule ... whatever, then highest strength is 300 mg
. Or what?
❝ Example phenytoin: Nonlinear PK (greater than proportional increase in AUC), NTID. Highest strength 100 mg (studies for the EMA). Highest approved therapeutic dose 3×100 mg (studies for the FDA).
If somebody creates a 300 mg tablet / capsule ... whatever, then highest strength is 300 mg

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Regards,
Detlew
Regards,
Detlew
Complete thread:
- Pharmacokinetic parameters CL, Vd and F mmw 2017-05-06 11:07 [Regulatives / Guidelines]
- Pharmacokinetic metrics CL, Vd and F Helmut 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 dummiesd_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 dummiesd_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 F Helmut 2017-05-06 12:14