2022 - Risk Assessment: Traditional and Novel Approaches to Assess and Manage Risks

Risk assessment is a complex process intended to protect human health by identifying drug-related hazards; determining dose-response relations for a product within relevant biological systems; and assessing exposure levels to characterize potential risks. These assessments may be conducted via traditional frameworks using data from in vitro and in vivo studies, as well as novel frameworks using pharmacokinetic and pharmacodynamic model-based prediction. Data used to assess risks are typically collected under conditions that mimic, as closely as possible, the clinical context in which a given product is intended for use. Across the mentioned frameworks, risk assessment must be based on clinically relevant information and include exposure data.
Risks may be characterized by evaluating the mechanism/mode of action, onset and offset and incidence of clinically relevant hazards. Traditional frameworks put risks into perspective based on the target organs of toxicity identified and the exposure levels at which hazards occurred. The exposure levels at which hazards occurred are used to identify the most sensitive species, which is typically deemed the most relevant species, unless proved otherwise.
Modeling approaches enable extrapolation of data from preclinical species to humans using established physiological differences. These approaches also allow prediction of hazard and exposure in scenarios not explicitly measured in preclinical studies. Modeling frameworks can be incorporated at a very early stage in the development pipeline and can also assist in determining which set of preclinical studies would be most clinically relevant.
Although these frameworks are intended for characterizing and putting potential risks into perspective, each is critical in managing potential clinical risks within relevant contexts to ensure patient safety.
Join the discussion on traditional and novel risk assessment frameworks, the advantages and disadvantages of these frameworks and explore case studies and perspectives on current and future challenges related to them.