CALIDAD

Permitted Daily Exposure (PDE)

In this course you will learn about the European Regulation, the PDE definition and the PDE derivation strategy.
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Difficulty

Expert

Duration

1 hour

Course Description

The Health Based Exposure Limits, also called Permitted Daily Exposure (PDE) represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime. This value is used to monitor the cross-contamination during the final drug manufacturing process.

This is what you are going to learn!

In this course we will explain the European Regulation, the PDE definition and the PDE derivation strategy as well as what the toxicological report must contain.
The course is addressed to Quality Assurance department, and workers associated to the manufacturing process.

Main Objetives

The following are the most important objectives to be achieved with the progress of the course:
  • Understanding the GMP requirements in relation to cross-contamination.
  • Knowing the EMA regulations in relation to the derivation of PDE limit values.
  • Learning the definition of a PDE.
  • Identifying the different PDE value derivation strategies.
  • Understanding and developing the different toxicological concepts and end-points.
  • Learning how to select the most appropriate starting points.
  • Knowing the criteria for assigning values to the adjustment factors.

Course contents