Bioequivalence and Bioavailability Forum

New Guidance - Methylphenidate [Regulatives / Guidelines]

posted by jag009  – NJ, 2016-02-02 21:16 (3802 d 02:27 ago) – Posting: # 15919
Views: 8,189

Hi all,

New guidances were posted for Methylphenidate ER last week from FDA: Metadate CD, Aptensio XR

Those guys really confuse me now Why AUC7-t and AUC8-t instead of AUC7-12 and AUC8-12 for Metadate CD?

John

Complete thread:

• New Guidance - Methylphenidatejag009 2016-02-02 20:16 
  • New Guidance - Methylphenidate Helmut 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