Bioequivalence and Bioavailability Forum

nobody nothing 2017-10-25 10:40 (3171 d 08:35 ago) Posting: # 17918 Views: 7,123	FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? [Regulatives / Guidelines] Post reply
	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 (3171 d 05:09 ago) @ nobody Posting: # 17919 Views: 5,949	FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? Post reply
	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 (3170 d 00:40 ago) @ nobody Posting: # 17927 Views: 5,852	FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? Post reply
	❝ ...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 (3169 d 11:36 ago) @ Achievwin Posting: # 17931 Views: 5,817	FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? Post reply
	❝ Yes but partial areas are still there They wont get rid of that. J

jag009
★★★

NJ,
2017-10-27 07:39
(3169 d 11:36 ago)

@ nobody
Posting: # 17930
Views: 5,886

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

Post reply

❝ 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

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

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

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

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

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