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Back to the forum  Query: 2017-11-22 10:25 CET (UTC+1h)
 
nobody
Senior

2017-10-25 08:40

Posting: # 17918
Views: 567
 

 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
Hero

Denmark,
2017-10-25 12:07

@ nobody
Posting: # 17919
Views: 464
 

 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??

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.
Achievwin
Junior

US,
2017-10-26 16:35

@ nobody
Posting: # 17927
Views: 385
 

 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
Hero

NJ,
2017-10-27 05:40

@ Achievwin
Posting: # 17931
Views: 356
 

 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
Hero

NJ,
2017-10-27 05:39

@ nobody
Posting: # 17930
Views: 335
 

 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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