Initial PK 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 PKPD analysis where appropriate

Tier 1:

• Population PK analysis (appropriate parameters considered to obtain non-linear Cl) including IV data (highest priority)
• Human data

Tier 2:

• Population PK analysis without IV data (obatin good estimate of CL/F and half-life)
• Any non-compartmental analysis data which includes figures showing PK profile over time
• Human data

Tier 3:

• Non-compartmental analysis parameters without figures showing PK profile over time
• Only summary data such as half-life, Cmax or F.
• Human data