XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec
Friday, April 20, 2018

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