OUR PERMITTED DAILY EXPOSURE (PDE) MONOGRAPHS

Permitted Dosage Exposure ("PDE") is the amount of a substance that a human or animal can take in daily over a lifetime without appreciable health risk.

For a given substance the PDE value depends on the target population and the route of administration. If not specified, the PDE is that of a 50 kg adult human.

Human PDEs

• The value of a PDE (adult, 50 kg) is expressed in mg/day
• The PDEs for pediatric products are expressed in mg/kg/day

As the guideline does not give a specific indication for ophthalmic specialties, the value used as a starting point for the calculation of our PDE ocular is based on an ocular value.

Veterinary PDEs

For pragmatic reasons, the cross-contamination guideline allows, for veterinary drugs, to determine the level of contamination from the human PDE. Thus, Socosur Veterinary PDEs are expressed in mg/kg/day.

Socosur Tox developed the method to include in each Veterinary PDE monograph, the full list of species sensitive to such molecule.

Any PDE monograph can be developed on demand

Our monograph rates are based on various factors such as development status, route of administration, specificities of veterinary or ophthalmological drugs, ... and are volume degressive.

More than one thousand PDE monographs have already been developed internally by Socosur Tox experts team,

please do not hesitate to consult our Developped PDE database.

Otherwise please simply on this link to place directly a prefilled quotation by email scs@socosur.eu

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