Pharmacokinetics and Biostatistics

Our Pharmacokinetics (PK) and Biostatistics division transforms raw bioanalytical and clinical data into clear, submission-ready evidence. Operating in strict adherence to ICH E9, US FDA, EMA, PPB and CDSCO statistical guidelines, our experienced pharmacokineticists and biostatisticians design robust study models and perform rigorous computational analyses to support Bioavailability/Bioequivalence (BA/BE) studies

By using validated, industry-standard software platforms, we deliver end-to-end bioanalytical solutions. Our services cover sample size estimation, power calculations, randomization schedule generation and complex PK modelling. For bioequivalence evaluations, we perform comprehensive parametric (ANOVA) and non-parametric statistical testing, calculating geometric mean ratios and 90% confidence intervals for primary PK parameters (Cmax, AUC0-t, AUC 0-∞) across 2×2 crossover, parallel, and replicate designs

Data integrity and regulatory transparency anchor every project. Operating under strict regulatory compliant workflows, we generate integrated pharmacokinetic-pharmacodynamic (PK/PD) reports, and audit-ready statistical analysis reports for inclusion in the final Clinical Study Report (CSR), ensuring seamless review by global regulatory authorities