Toxicology Monographs

In biopharmaceutical/pharmaceutical development, it is necessary to characterize the safety of the components of a drug product. Such assessments are important to ensure the health and safety of manufacturers, health care providers, and patients. ToxStrategies scientists, including board-certified toxicologists, are experts in preparing toxicology monographs. Such monographs are tailored to the needs of the client and evaluate the potential health hazards of product- and process-related impurities, degradants, solvents, and novel excipients in drug substances and drug products.

Selected examples of our experience include:

  • Assessment of impurities, degradants, novel excipients, and solvents including growth factors and other biological components
  • Compilation of data (e.g., physical, chemical, metabolism and kinetics data; mechanism of action)
  • Extensive and critical in-depth review of data, including primary literature, proprietary data, and regulatory information and guidelines
  • Nonclinical safety evaluation (in vitro and in vivo) of pharmacokinetics/ADME, pharmacology, safety pharmacology, general toxicology, reproductive toxicology, and carcinogenicity data
  • Identification of data gaps and recommendations for additional toxicity testing
  • Derivation of health-based exposure values (e.g., PDE) for specific populations and routes of exposure based on regulatory expectations (FDA, EMA, OSHA, EPA, AIHA, CalEPA Proposition 65, etc.)
  • Preparation of regulatory briefing packages to support exposure limits
  • Impact assessment of potential safety and regulatory implications
  • Monograph updating services to review literature on a regular basis

Impurity or excipient monographs can be written to support a specific product (e.g., biologic, cell therapy, or small molecule) or more broadly for general use. Several factors need to be considered, including the physicochemical characteristics of the compound of interest, potential routes of exposure, and the disease indication. After identifying the key health hazards, ToxStrategies determines risk-based limits such as permissible daily exposures (PDEs), as well as occupational exposure limits (OELs), or occupational hazard bands (OHBs). Assessments may include identification of data gaps and recommended toxicology testing (also supported by ToxStrategies).

For more information about our services, please contact us.

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