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PERMITTE DAILY EXPOSURE (PDE)/OEL MONOGRAPHS:
PDE values are based on the toxicological properties and pharmacology of the specific active pharmaceutical ingredient (API).
Determination of a PDE involves:
Hazard Identification by reviewing all relevant data.
Identification of 'critical effects'.
Determination of the no-observed-adverse-effect level ( NOAEL ) of the findings that are considered to be critical effects.
Use of several adjustment factors to account for various uncertainties.
PDE (mg/day)= NOAEL (mg/kg/day) X body weight (kg)
F1X F2 X F3 X F4 X F5
Reports are prepared by an scientific expert team and reports will be approved by DATB certified toxicologist
ICH Topic Q3C (R4). Impurities: Guideline for Residual Solvents (CPMP/ICH/283/95)
VICH GL18 (R): Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/99-Rev.1).
ICH Q3D. Elemental Impurities. (Sept.2015)
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