highest dose ⇔ strength for dummies [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2017-05-10 18:20 (2514 d 19:26 ago) – Posting: # 17347
Views: 9,530

Dear Helmut,

❝ Example phenytoin: Nonlinear PK (greater than proportional increase in AUC), NTID. Highest strength 100 mg (studies for the EMA). Highest approved therapeutic dose 3×100 mg (studies for the FDA).


If somebody creates a 300 mg tablet / capsule ... whatever, then highest strength is 300 mg :confused:. Or what?

Regards,

Detlew

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