A Comprehensive Guide on Permitted Daily Exposure (PDE) Calculation, The Evaluation of Toxicity Data for Potential Elemental Impurities and Toxicological Concerns in The Manufacturing of Pharmaceutical Products.
The derivation of a threshold value (permitted daily exposure (PDE) or threshold of toxicological concern (TTC) should be the result of a structured scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data. Risk evaluation and safety certification of chemical contaminants in a drug substance is the responsibility of toxicologists. PDE values play a vital role in the risk assessment process. Toxicologists use those values for the safety qualification of various types of impurities found in a drug substance.
This white paper primarily focuses on providing comprehensive insight to pharmaceutical companies for understanding PDE report requirements and the steps involved in PDE calculation as per the EMA and FDA Q3D(R1) Elemental Impurities Guidelines.