PK/STAT analysis in Bioequivalence studies

We have specialized Biostatisticians with ample of experience in handling all types of BA/BE studies like crossover design studies, food effect studies, dose proportionality studies etc.

Software Experience: SAS, WINONLIN

We can help you with:

Study designing i.e. type of design suitable for particular molecule depending upon its PK characteristic, variability and regulatory requirements.
Sample size Estimation.
Writing a Pharmacokinetic and statistical section in protocols for BA/BE studies with design like two way cross-over, partial/fully replicate crossover, parallel, group sequential etc.
Preparation of randomization schedule for designs mentioned in 3rd point.
Pharmacokinetic analysis of analytical concentration data as per regulatory requirements.
Statistical analysis of the pharmacokinetic data as per protocol and regulatory requirements.
Writing a PK and Statistical part of final report for regulatory submission.
Response to queries from different regulatory.

Apart from above mentioned phases in BA/BE studies, we can also assist you with:

In-vitro In-vivo correlation for modified release dosage forms of molecule using IVIVC toolkit in WINONLIN software.
Designing study and writing SAS codes for Statistical analysis of particular molecules like Orlistat, Sevelamer etc., for which regulatory has asked for analysis different from regular BA/BE analysis.