Pharmacokinetics & Statistics:

QPS Bioserve has a dedicated and experienced Pharmacokinetics and Statistics team with expertise in the application and presentation of Pharmacokinetics and Statistical principles critical for successful approval of product submissions.

Our services include:

• Bioequivalence analysis
• PK and PK/PD analysis
• InVitro InVivo Correlation (IVIVC)
• PK and Statistical reports for Regulatory submissions (using WinNonlin and SAS)

The PK group also independently manages an access and temperature controlled pharmacy for the Receipt, Storage, Handling and Archival of Study Drug Products.

Infrastructure

• Pharmacokinetic analysis on WinNonlin 5.0.1 and Statistical analysis on SAS 9.1.3
• Access and Temperature Controlled Pharmacy