• Understanding the basic PK and metabolism characteristics of the drug compound will eventually reveal the appropriate drug regimen for a patient.
• The pharmacokinetic parameters of BE/BA studies are calculated using KINETICA 2000(Version 4), a proprietary software for BE studies. The pharmacokinetic/ statistical analysis is done according to FDA guidance.
• A team of Pharmacokinetic Scientists are experts in their field, having been working with standard study designs and generated innovative study designs to generic drug equivalents programs to support drug submissions to multiple regulatory markets across the globe.

Zi Diligence has expert biostatisticians that can assist in Sample size and power calculation using SAS® software, design and analysis of the study data. R software, Package PowerTOST is used for the estimation of sample size. Validated Kinetica™ 5.1 SP1 is used for pharmacokinetic calculations; validated SAS™ analytics Pro 9.4 software is used in statistical analysis and bioequivalence testing. The pharmacokinetic/ statistical analysis is done according to FDA, EMA guidelines) at the end.