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