Bioequivalence and Bioavailability Forum

EMA Dose proportionality [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2015-07-13 10:19 (4000 d 20:34 ago) – Posting: # 15074
Views: 3,972

Dear Pandu,

from your quote of the EMA guideline dose proportionality assessment in the EMA sense is much simpler than struggling with "power model" or other sophisticated analyses:

• Calculate the dose normalised PK metric AUC
• Calculate the mean ratio of dose normalised AUC's comparing the studied strength (or strength in the planned bioequivalence study) and the strength(s) for which a waiver is considered
• Decide dose linearity if the ratio is within 75 ... 125%

That is it. Simple enough IMHO .
No statistics beside calculating means.

Complete thread:

• Dose proportionality using Power Model Pandu 2015-07-12 12:55 
  • EMA Dose proportionalityd_labes 2015-07-13 08:19