Bioequivalence and Bioavailability Forum • FDA guide methylphenidate oral ER tablet

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

posted by jag009 – NJ, 2017-10-27 07:39 (2365 d 20:49 ago) – Posting: # 17930
Views: 4,468

❝ 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

Complete thread:

FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? nobody 2017-10-25 08:40 [Regulatives / Guidelines]
- FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? ElMaestro 2017-10-25 12:07
- FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? Achievwin 2017-10-26 16:35
  - FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? jag009 2017-10-27 05:40
- FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?jag009 2017-10-27 05:39