Initial PK quality Tiers and publications

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

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