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RegisterCFDA 2016 BE-GL [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2017-05-09 15:52 (2978 d 23:11 ago) – Posting: # 17334
Views: 10,805
Hi Shuanghe,
THX for the update!
If I trust in Google-translate:
AUC0–72 only for drugs with a long half-life. What does the last sentence mean?
Seemingly no reference-scaling.
Multiple strengths of drugs with nonlinear PK (grater than proportional increase in AUC)?
The latest one (as you did)…
❝ […] in 2016, they also published another BE guideline (3rd attachment, in Chinese), which is basically a copy from FDA's BE guidance.
THX for the update!
❝ So it's a bit of mess now as you can imagine. e.g., FDA and EMA has quite different opinion about fasting and/or fed study for solid oral immediate-release dosage forms (depending on SPC's recommended administration method), in addition to many other aspects.
If I trust in Google-translate:
AUC0–72 only for drugs with a long half-life. What does the last sentence mean?
Seemingly no reference-scaling.
Multiple strengths of drugs with nonlinear PK (grater than proportional increase in AUC)?
EMA: highest strength.
FDA: highest therapeutic dose.
CFDA?
❝ Which guideline should one follow?
The latest one (as you did)…
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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-GLHelmut 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-GLHelmut 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
Ing. Helmut Schütz