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RegisterNew Guidance - Methylphenidate [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2016-02-03 15:10 (3798 d 16:36 ago) – Posting: # 15923
Views: 6,849
Hi John,
Duno. Citizen petition (aka straw men of the innovator)? Do you remember this one? The FDA received five comments. Most interesting the one by the two Lászlós about the S×F interaction and the one by Mallinckrodt about the clincial relevance of the new cut-off times.
❝ Those guys really confuse me now 
Why AUC7-t and AUC8-t instead of AUC7-12 and AUC8-12 for Metadate CD?
Duno. Citizen petition (aka straw men of the innovator)? Do you remember this one? The FDA received five comments. Most interesting the one by the two Lászlós about the S×F interaction and the one by Mallinckrodt about the clincial relevance of the new cut-off times.
—
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!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- New Guidance - Methylphenidate jag009 2016-02-02 20:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- New Guidance - MethylphenidateHelmut 2016-02-03 14:10
- New Guidance - Methylphenidate jag009 2016-02-03 22:53
- Probably based on PK/PD modelling mittyri 2016-02-04 23:35
- Probably based on PK/PD modelling jag009 2016-02-05 23:00
- New Guidance - MethylphenidateHelmut 2016-02-03 14:10
Ing. Helmut Schütz