highest dose ⇔ strength for dummies [Regulatives / Guidelines]
Dear Detlew,
Not easy. First of all, what is the reference? For the EMA it is the product which was approved based on a complete dossier (acc. to article 8(3), 10a, 10b or 10c of 2001/83/EC). Say the highest strength was 100 mg and up to 300 mg were used in phase III. Hence, the innovator can develop a new 300 mg strength and get it approved in a line extension (only BE studies 300 mg vs. 3×100 mg).
Tricky for a 300 mg strength not developed by the originator:
❝ ❝ 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 .
Not easy. First of all, what is the reference? For the EMA it is the product which was approved based on a complete dossier (acc. to article 8(3), 10a, 10b or 10c of 2001/83/EC). Say the highest strength was 100 mg and up to 300 mg were used in phase III. Hence, the innovator can develop a new 300 mg strength and get it approved in a line extension (only BE studies 300 mg vs. 3×100 mg).
Tricky for a 300 mg strength not developed by the originator:
- Highest strength of the innovator still 100 mg. Hybrid application (acc. to 8(3) of 2001/83/EC): Comparative BA 300 mg vs. 3×100 mg plus clinical studies.
- Highest strength of the innovator already 300 mg. Strictly speaking this product was not approved based on a complete dossier (but a line extension). IMHO, you cannot apply for a purely generic application (300 mg vs. 300 mg). Is case (a) applicable? Duno. Ask a lawyer and go for a
scientificregulatory advice.
—
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
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 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 dummies d_labes 2017-05-10 16:20
- highest dose ⇔ strength for dummiesHelmut 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 dummiesHelmut 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 F Helmut 2017-05-06 12:14