This forum will be used to initiate discussions related to the handling of data and supportive programming for Pharmacokinetic (PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) or Pharmacometric analysis. We welcome discussions on programming issues, tips, best practices, and standardization across industry and academics.
Objectives:
• Establish a forum for pharmacometric and pharmacokinetic programming across industry and academics
• Collect and share best practices, ideas, challenges and examples for providing programming to support pharmacometric and PK analysis
• Share ideas of training new PKPD programmers (standard curriculum)
In Scope:
• Programing to support NCA and pharmacometric analysis:
• NCA datasets
• Population PK and exposure-response datasets
• TFL for reporting
• CDISC standards (including ADPC and ADPP)
• E-submission
• Simulation
• Quality control
Out of Scope:
• Conducting NCA and pharmacometric analysis.