Our PDES

Permitted Daily Exposure (PDE) Monographs

 

More than 1 000 APIs substances PDEs reports have already been developed by Azierta.

 

New monographs are regularly developed.


Any PDE monograph can be developed upon request.


Our rates of Azierta PDE monographs are based on the status of development of the monograph, and discounts can be granted upon scale up quantities.

List of PDES

A B C D E F G H I K L M N O P Q R S T U V W X Z

QUOTATION REQUEST

 

Evaluation of cross-contamination risk and calculation of the pde

 

The cross-contamination risk in the manufacture of different medicinal products in shared facilities has recently been included at the core of new European regulation with the revision of Chapters 3 and 5 and Annex 15 of the EU GMP Guide and the implementation of EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA/CHMP/ CVMP/ SWP/169430/2012)”. This new regulatory environment encourages pharmaceutical-industry actors to establish limit values for the validation of cleaning processes.

 

In compliance with this regulation, the determination of health based exposure limits for a residual active substance is based on the calculation of the Permitted Daily Exposure (PDE).

PDE are based on all available pharmacological and toxicological data including both non-clinical and clinical data.

 

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.

Alpha list of PDES

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