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Initial PK quality Tiers and publications

Initial PK quality Tiers and publications

Owned by Dave Fairman (Deactivated)

Initial proposal of tiering for PK quality and example publications for each tier.

  File Modified

Microsoft Word Document Mab PK Tiers.docx Draft tier description

Dec 19, 2018 by Dave Fairman (Deactivated)

mAb PK Tiers:

In all cases PK analysis means PK/PD analysis where appropriate

Tier 1 quality criteria (link to Tier 1 publications):

  • Population PK analysis performed, including IV data (highest priority)
  • Reliable estimate of non-linear systemic CL and its variability is available (highest priority)
  • Human data
  • Confidence in data is such that it would be used in a PK/PD model as 'real' data

Tier 2 quality criteria (link to Tier 2 publications):

  • Population PK analysis performed, without IV data (only sub-cut)
  • Good estimate of CL/F and terminal half-life; potential scenario(s) = not good estimate of F but perhaps good understanding of half-life
  • Target-mediated effects or non-linearity highlighted  
  • Any non-compartmental analysis (NCA) data which includes figures showing PK profile over time (provide the option to extract further data if needed)
  • Human data

Tier 3 quality criteria (link to Tier 3 publications):

  • NCA parameters without figures showing PK profile over time (certain degree of uncertainty around parameters)
  • Only summary data such as AUC, half-life, Cmax or F.
  • Human data
  • Confidence in data is such that it would not be used in a PK/PD model

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