Pharmacokinetic analysis and clinical trial services

XenoBiotic Laboratories (XBL) provides pharmacokinetic evaluation based on validated software packages including WinNonLin® software. Additional PK related services are available through collaboraton with highly qualified consultants that are strategically allied with XBL to provide services such as:

• Design, data analysis and report preparation of Phase I through Phase IV PK and PK/PD related studies
• - Population PK/PD analysis
• - Analysis of limited PK samples
• - Analysis of pediatric PK and PD data
• - In vitro - in vivo correlations (IVIVC) of sustained-release formulations
• - Non-compartmental PK analysis of Phase I PK studies, including bioequivalence, food effect, drug interaction and special population PK
• Clinical trial simulations to optimize clinical success and reduce time to market
• - Use of existing information from prior studies and literature
• - Better quantification of uncertainty parameters
• - Power analysis
• - Use of "what if" scenarios for clinical outcome analysis
• - Rehearsed analysis planning
• Preparation of pharmacokinetic and clinical pharmacology technical summaries for all regulatory submissions
• Development of innovative PK and PD modeling for trial simulation and facilitating new drug product development