Toxicology Monographs

The thorough characterization of potential health hazards for pharmaceutical components of a drug product is a necessary practice within the pharmaceutical industry. Such assessments are important to ensure the health and safety of:

  1. Workers handling the drug during manufacturing
  2. Health-care providers administering the drug
  3. Patients receiving the drug during treatment.

ToxStrategies staff scientists, including several board-certified toxicologists, have extensive experience in the preparation of toxicology monographs in support of pharmaceutical/biopharmaceutical development. Such monographs describe and evaluate the potential health hazards of product- and process-related impurities, degradants, solvents, and novel excipients associated with pharmaceutical drug substances and drug products. The data included in these monographs are used to determine risk-based limits, such as permissible daily exposures (PDEs) in support of clinical development, as well as occupational exposure limits (OELs) or occupational hazard bands (OHBs) in support of manufacturing. In some cases, assessments identify data gaps to be addressed by subsequent nonclinical toxicology testing, which ToxStrategies also supports. The monographs are tailored specifically to meet the needs of the client. Examples of areas where our staff have extensive experience include:

  • Assessment of a variety of product- and/or process-related components, including impurities, degradants, novel excipients, and solvents.
  • Compilation of data (e.g., physical, chemical, metabolism, and kinetics data; mechanism of action)
  • Nonclinical safety evaluation (in vitro and in vivo) of pharmacokinetics/ADME, pharmacology, safety pharmacology, reproductive toxicology, and carcinogenicity data
  • Evaluation of available clinical data
  • Extensive and critical in-depth review of data, including primary literature, proprietary data, and regulatory information and guidelines
  • Identification of key data gaps and recommendations for additional toxicity testing
  • Derivation of health-based exposure values (e.g., PDEs) for populations and routes of interest based on appropriate regulatory expectations (e.g., FDA, OSHA, EPA, AIHA, CalEPA Proposition 65)
  • Preparation of regulatory briefing package to support the rationale and scientific justification for exposure limits
  • Impact assessment of potential safety and regulatory implications

For more information about our services, please contact us.

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