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On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically-based pharmacokinetic (PBPK) analysis.  The “first-of-its-kind” guideline, published earlier on July 21, 2016, proposes...[read more]
  • 6 January 2017
  • Author: Ping Zhao, PhD
  • Number of views: 631
  • Comments: 0
Do time-to-tumor-growth (TTG) metrics need to be corrected for time-dependent bias in pharmacometric oncology models?
A main objective of the application of pharmacometrics in oncology is to develop drug-independent models to link tumor-growth-inhibition (TGI) metrics, such as...[read more]
This month, PSP features a contribution from Pelligrand et al.1, the topic of which is unusual for PSP in the sense that the paper does not relate (directly or indirectly) to human pharmacology, but is concerned with a population pharmacokinetic analysis of robenacoxib in...[read more]
A Six Step Workflow to Demystify Systems Pharmacology Model Development and Application

Quantitative Systems Pharmacology (QSP) is a rapidly developing and evolving field that has relatively recently emerged from the confluence of systems biology and quantitative pharmacology. This natural emergence has sprung from...[read more]

Great Tools are Available for Communication and Education
I recently read "A Tutorial on Target-Mediated Drug Disposition (TMDD) Models" by Dua, Hawkins, and van der Graaf, published in CPT: Pharmacometrics & Systems Pharmacology. Not being myself a pharmacometrician, with very limited knowledge of these models, I was happy to see...[read more]
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