No Pharmacokinetic or Bioequivalence data available on Primidone to asses exact sample size for pivotal biostudy.
Pivotal protocol with sample size re-estimation approach, interim analysis, group effect, statistical calculations, BE approaches; application of certain statistical tests was designed.
Designing the study protocol with provision or strategies which allow to re- estimate the sample size and continue the study especially when Primidone belongs to an NTI category.
A third party biostatistician (a part from sponsor and CRO) was appointed to perform the interim analysis of rate and extent of absorption, who based on the reported intra subject variability results provided the final sample size on which study was to be extended in groups.
Special statistical calculation are required other than normal BE sequential approaches to avoid bias of investigator.
Our in house expert team of biostatistics, deployed stringent and accepatable statistical approaches while interpreting the results of study based on which the bioequivalence was proved maintain the regulatory compliance.
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