EMA Dose proportionality [Regulatives / Guidelines]
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:
.
No statistics beside calculating means.
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%

No statistics beside calculating means.
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Regards,
Detlew
Regards,
Detlew
Complete thread:
- Dose proportionality using Power Model Pandu 2015-07-12 12:55 [Regulatives / Guidelines]
- EMA Dose proportionalityd_labes 2015-07-13 08:19