PHARMA

REACH mastery offer assistance in drug development from discovery to registration. We can assist in the following fields:

A. Review of Toxicological in new drug discovery (New Chemical Entities)

B. Contracting and monitoring of new tests

C. Human health risk assessment

D. Dossier strategy evaluation

E. Authorisation process and dossier

Daily exposure of workers in the pharmaceutical industry to the active pharmaceutical ingredients can represent a risk.

The challenge to toxicologists and other health professionals is to determine a value that has an adequate margin between a level that produces undesired health effects and one that does not.

Protection of the worker requires the determination of occupational exposure limits (OEL).

The residual presence of pharmacologically active substances should be limited to a level scientifically / toxicologically considered safe for all those who will be exposed (operators / end users). Thus a threshold value, which allowed daily exposure (PDE) should result from a thorough and structured evaluation of toxicological and pharmacological including both non-clinical and clinical.

The determination of the PDE (Permitted Daily exposure) following the guideline http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/11/WC500177735.pdf
It includes:

A. Review of all the pharmacological and toxicological data for hazard identification
B. Identification of the critical effects and toxicological evaluation
C. Analysis and use of correction factors in order to allow the most realistic extrapolation of the values of non effect in humans
D. Calculation of its PDE (permitted daily exposure)