Hi,
Some guidelines state that the calculation of PDE/ADE must be carried out by ‘toxicological experts’. Is this compulsory or not?
What is the value for ‘Weight Adjustment’? I see some guidelines propose 50, 60, others propose 70. I don’t know what factors affect this variation.
Thank you.
Hi,
I’m not sure if it’s compulsory but you need someone with the appropriate expertise to determine the uncertainty factors F1-F5.
In Europe the value used for weight adjustment is 70kg (weight of average adult). I do not know of any other values used.
KR,
Claudia
Hi Claudia,
Thank you for the answer.
When it comes to F(s) values, I see EMA and PICS guidelines use F1xF2xF3xF4xF5, while APIC applies UFc x PK x MF. Is there any difference?