Regulatory Aspects of PK/PD – (modelling). Karolina Törneke Senior expert, member of the CVMP. Part 1A-C Administrative data and product information. Part 2 Pharmaceutical documentation. PK/PD!. Part 3A-B Pharmaco/toxicological and residue documentation.
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Senior expert, member of the CVMP
Administrative data and product information
Pharmaco/toxicological and residue documentation
Part 4.1 Clinical pharmacology and toxicology
Part 4.2 Clinical trials
Even if the guidelines don’t talk about PK/PD as mandatory, integration of PK and PD data could be very informative and helpful
50 mg/kg: all experienced serious adverse reactions.
30 mg/kg: 4/5
20 mg/kg: 1/8
0-15 mg/kg: zero events
Can 5-20 mg/kg be regarded as safe?
The ”Painkill” example
How to find the dose for a new species
when several species are approved already with different doses?
So before Painkill can be approved for a new species new clinical documentation on dose finding must be presented. Then PK/PD might be a valuable shortcut.
Sp 1: 1 (standardized unit/kg bw)
Sp 2: 5
The dose differed accordingly and the systemic exposure was similar!
New species: 5
Knowledge about the PK/PD relationships for efficacy and safety is important for the development of appropriate dosing recommendations. The pharmacodynamics could be altered in renal impairment, which could lead to altered PK/PD relationships.
(EU NfG Renal impairment studies (2004))
The best and most advanced of all study designs might give results that are useless for assessors!
If both those questions could be answered and the
answer is “yes” to both then the rest is “nice to know”!