Cleaning validatin based on PDE concept

(Mitesh Patel) #1

Respected all,
Please guide me for below content mentioned for finding of MACO value as per PDE concept.
Acutely I could not understand it for how to find out below value and from where. Any references for finding the value of UFc, MF, PK and F1-F5.

UFc
Composite Uncertainty Factor: combination of factors which reflects the inter- individual variability, interspecies differences, sub-chronic-to-chronic extrapolation, LOEL-to-NOEL extrapolation, database completeness.

MF
Modifying Factor: a factor to address uncertainties not covered by the other factors

PK
Pharmacokinetic Adjustments

F1-F5 .
Adjustment factors to account for uncertainties. Refer to EMA Guidance 2 for further explanation.Preformatted text

(Md.Asif Hussain) #2

These values are basically derived on toxicology basis.

PDE values/monographs/reports are provided by the certified toxicologists.
(You can refer organization-Azierta, Affigility, vanguard etc.)

Thanks

(Dr. Ahmed Mohamed Awad) #3

EMA Q & A on EMA guideline on setting limits.pdf (147.7 KB)