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
• route of administration

If not specified, the PDE is that of a 50 kg adult human.

Human PDEs

• Value of a PDE (adult, 50 kg) is expressed in mg/day
• 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, Toxby.design Veterinary PDEs are expressed in mg/kg/day.

Nevertheless Toxby.design developed a method to include for each Veterinary PDE monograph

a full list of species sensitive to such molecule.

Any PDE monograph can be developed on demand

Our PDE monographs pricing rates are based on various factors such as 

• development status
• route of administration
• specificities such as veterinary or ophthalmological indications, etc

...and are volume degressive

More than one thousand PDE monographs have already been developed internally by Toxby.design experts team,

and below database is updated weekly