Toxicology

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At PharmEng Technology, we understand the importance of evaluating the toxicity of biopharmaceuticals, therapeutic proteins, chemicals, active pharmaceutical ingredients, and components. 

We offer toxicology services that include the following: 

  • Determine the potential for health effects, pharmaceutical cleaning limits, personal injury litigation support, worker’s compensation assistance, product safety based on information provided by the client.
  • Acceptable Daily Exposure (ADE) – “safe” limits for product cross-contamination purposes (multipurpose manufacturing operations) under the ISPE RiskMaPP Model (ug of API/day)
  • Permitted Daily Exposure (PDE) – “safe” limits for product cross-contamination purposes (multipurpose manufacturing operations) under European Medicines Agency (EMA) Guideline (ug of API/day)
  • Occupation Exposure Limits (OEL, ug of API/m3) – established for worker safety purposes & restrict the amount & length of time a worker is exposed to airborne concentrations of hazardous biological or chemical agents
Toxicology

Toxicological Assessments:

  • Hazard identification
  • Critical effects
  • Determination of No Observed Adverse Effect Level (NOAEL)
  • Uncertainty Factors
  • Modifying Factor
  • Pharmacokinetic Adjustment (s)

In addition, PharmEng Technology will provide Employee Safety Training after the project is complete. This includes: 

  • Discuss proper Personal Protective Equipment (PPE)
  • Pharmacological mechanism of action
  • Target organ/systemic toxicity
  • Review signs and symptoms of possible exposure
  • Overview of adverse effects
  • Existence of toxic metabolites
  • Evaluation of exposure routes
  • Cited literature
  • Summary of toxicity