Categorization and placement of active pharmaceutical ingredients into control bands is an important step in the drug development process and a necessary part of any potent compound safety program. In addition, the European Medicines Agency (EMA) has recently required the development of acceptable daily exposure (ADE) values—also known as permissible daily exposure (PDE) values—for active pharmaceutical ingredients. In most cases a preliminary assignment of a potent compound should occur shortly after the decision to pursue development has been determined. Affygility Solutions' experienced industrial hygiene and toxicology professionals can determine the proper control band assignment, occupational exposure limit, and acceptable daily exposure value for your APIs.
Our OEL Fastrac catalog contains monographs with OEL and ADE/PDE values for many existing generic compounds.
Our prices are very competitive and turn around is rapid. We can assign your potent compound to either your own internal control banding scheme or to the 4- or 5-band systems common to many potent compound safety programs. Contact us for a custom occupational exposure limit (OEL) or visit our OEL Fastrac page for a list of existing OEL monographs available for immediate download.
As the trend towards more potent pharmaceuticals continues, environmental health and safety professionals (EHS) in the industry must respond by taking measures to prevent and control exposures. These measures include:
The EHS and toxicology professionals at Affygility Solutions have performed thousands of potent compound categorizations and development of occupational exposure limits for active pharmaceutical ingredients. Contact us today to discuss how we can assist you in categorization or classification of your active pharmaceutical ingredient (API).
Contact us to find out about our availability and rates for conducting audits of your EHS program or facility.