Permitted Daily Exposure catalog

OUR PERMITTED DAILY EXPOSURE (PDE) MONOGRAPHS

Any PDE monograph can be developed on demand

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

• Development status
• Route of administration
• Specificities such as veterinary or ophthalmological indications, etc.

...and all PDEs are sliding scale

Permitted Daily Exposure ("PDE") is the amount of a substance that a human or animal can take 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

Since EU guidelines do not indicate a specific PDE threshold for ophthalmic specialties, the value we use as a starting point for the calculation of our PDEs is based on an ocular value.

Veterinary PDEs

For veterinary drugs, the cross-contamination guideline allows us to determine the level of contamination from the human PDE. So, Veterinary PDEs are also expressed in mg/kg/day.

Tox By Design has developed a method to include a full list of species sensitive to each molecule for each Veterinary PDE monograph.

More than 1,500 PDE monographs have already been developed internally by the Tox By Design experts team. You can access our database that is updated weekly below: