Bioequivalence and Bioavailability Forum

highest dose ⇔ strength for dummies [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2017-05-10 17:45 (3328 d 08:07 ago) – Posting: # 17346
Views: 11,976

Dear Detlew,

❝ what I always wondering about and didn't dare to ask such silly question:

Dare To Be Stupid

❝ What is highest dose ⇔ strength?

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).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Pharmacokinetic parameters CL, Vd and F mmw 2017-05-06 11:07 
  • Pharmacokinetic metrics CL, Vd and F Helmut 2017-05-06 12:14
    • Pharmacokinetic metrics CL, Vd and F Shuanghe 2017-05-08 16:16
      • CFDA 2016 BE-GL Helmut 2017-05-09 13:52
        • CFDA 2016 BE-GL Shuanghe 2017-05-10 13:03
          • nonlinear PK: highest dose ⇔ strength Helmut 2017-05-10 15:17
            • highest dose ⇔ strength for dummies d_labes 2017-05-10 15:41
              • highest dose ⇔ strength for dummiesHelmut 2017-05-10 15:45
                • highest dose ⇔ strength for dummies d_labes 2017-05-10 16:20
                  • highest dose ⇔ strength for dummies Helmut 2017-05-10 16:28
                    • highest dose ⇔ strength for dummies d_labes 2017-05-11 16:31
                    • highest dose ⇔ strength for dummies mmw 2017-05-15 06:53