Pharmacokinetics and Statistics

• 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 guidelines.
• 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 calculations using SAS® software, design and analysis of the study data. R software with the PowerTOST package is used for sample size estimation. 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 conducted according to FDA and EMA guidelines.