nobody
nothing

2017-10-25 10:40
(2347 d 03:53 ago)

Posting: # 17918
Views: 5,362
 

 FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? [Regulatives / Guidelines]

Hy!

Brand new FDA guideline on methylphenidate

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM581432.pdf

...apparently they skipped this "subject-by-formulation" part of the thing...

Kindest regards, nobody
ElMaestro
★★★

Denmark,
2017-10-25 14:07
(2347 d 00:27 ago)

@ nobody
Posting: # 17919
Views: 4,508
 

 FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?

Hi No-wan kenobi,

❝ ...apparently they skipped this "subject-by-formulation" part of the thing...


What??!!!??! Are you seriously saying someone applied some degree of common sense in the guidance??

Pass or fail!
ElMaestro
Achievwin
★    

US,
2017-10-26 18:35
(2345 d 19:58 ago)

@ nobody
Posting: # 17927
Views: 4,405
 

 FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?

❝ ...apparently they skipped this "subject-by-formulation" part of the thing...


Yes but partial areas are still there
jag009
★★★

NJ,
2017-10-27 07:40
(2345 d 06:54 ago)

@ Achievwin
Posting: # 17931
Views: 4,424
 

 FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?

❝ Yes but partial areas are still there


They wont get rid of that.

J
jag009
★★★

NJ,
2017-10-27 07:39
(2345 d 06:55 ago)

@ nobody
Posting: # 17930
Views: 4,441
 

 FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?

❝ Brand new FDA guideline on methylphenidate


https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM581432.pdf


❝ ...apparently they skipped this "subject-by-formulation" part of the thing...


Yes for Ritalin SR. I've said it many times to people. That Sub-by-form interaction testing part is really only applicable to Concerta! If one tried to make sense of it.

J
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