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