PDE/ADE calculation

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?


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