Bioequivalence and Bioavailability Forum

highest dose ⇔ strength for dummies [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2017-05-10 18:20 (3336 d 06:07 ago) – Posting: # 17347
Views: 12,127

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 . Or what?

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 dummies Helmut 2017-05-10 15:45
                • highest dose ⇔ strength for dummiesd_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