This webinar will introduce the concepts of OELs and PDEs and discuss applying risk assessment methodologies to the non-clinical and clinical data on active pharmaceutical ingredients to arrive at scientifically defensible values to develop containment performance targets for the quantitative monitoring of workers’ exposure and to establish acceptable limits for patient safety, respectively. 

The synthesis, formulation, and overall production of drug substances and drug products involves the handling of numerous chemicals that have the potential to create occupational and product safety concerns.

Quantitative hazard assessment is required to establish scientifically defensible limits of exposure in the workplace as well as levels of a drug substance that are acceptable as a contaminant in another drug product. 

• A Permitted Daily Exposure (PDE), as defined in guidance by the European Medicines Agency (EMA), is a health-based limit and represents a dose (either oral, IV, or otherwise specified) that is unlikely to cause an adverse effect if an individual is exposed, by that route, at or below this dose every day for a lifetime. 

  
  

• An Occupational Exposure Limit (OEL) is an acceptable limit for worker exposure over an 8-hour day, 40-hour week for a worker’s lifetime and is used as a basis for establishing exposure control measures.

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