PDE values are based on the toxicological properties and  pharmacology of  the specific active  pharmaceutical ingredient (API).

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 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

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 Reports are prepared by an scientific expert team and reports will be  approved by  DATB  certified  toxicologist

 

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 REFERENCE TEXTS

 

• 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)