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The Pros and Cons of Using Animal Models in Nonclinical Safety Assessments

When performing a nonclinical evaluation of new chemical entities (NCEs) to assess any potential safety risks to humans, conventional healthy animals (CHAs) are used more often than not. But, in reality, animal models of diseases (AMDs) can play a critical role in the understanding of the health risks to humans regarding NCEs. This is especially true when there’s a need to evaluate how someone might respond after exposure to a particular NCE based on whether or not that person has a specific disease. So, does that mean we should see greater widespread use of AMDs in nonclinical safety assessments? Not necessarily. While AMDs offer potential benefits in evaluating health risks, they also have their own limitations that warrant consideration. What matters more isn’t an increased usage of AMDs across the board; rather, knowing when to observe any and all AMDs of interest regarding a specific NCE is crucial to gaining a deeper understanding of the potential health risks that NCE holds. Optimizing the use of AMDs in nonclinical safety assessments starts with building a greater understanding of their pros and cons. This recent article, Opinion on the Use of Animal Models in Nonclinical Safety Assessment: Pros and Cons, by Radhakrishna Sura, Julie Hutt, and Sherry Morgan, offers an in-depth breakdown of the major pros and cons of using AMDs. You can also get a broad overview of both the advantages and limitations of AMDs right here in this blog post. Keep reading to learn when you should consider using AMDs in your safety assessments, and then read this article for additional insights. Pro: AMDs are potentially more predictive of adverse events Traditionally, AMDs are used to better understand the pathogenesis of a disease, and to establish a nonclinical proof-of-concept regarding the target validation and efficacy in potential drug treatments. On the other hand, AMDs have largely been relegated for use in nonclinical safety assessments that explore specific hypothesis-driven studies. The tide, however, appears to be turning. Regulatory agencies have gone so far as to actually encourage the use of AMDs in support of drug development programs. If a target or substrate is only present in the disease state, then conducting a toxicity study in AMDs as an alternative to CHAs makes sense. In these situations, AMDs may be more predictive of potential adverse events in humans than CHAs. Con: A greater potential for confounding effects resulting from heterogenous expression of a disease Naturally occurring hereditary diseases may have variable degrees of expression in a population. Conversely, environmental factors and chemically or surgically induced diseases can also impact disease expression in a nonuniform manner. To offset these confounding factors, scientists often have to use a large number of animals and pay close attention to randomization prior to the initiation of therapeutic administration. Having to acquire and categorize so many animals based on the demands of a given study can require a substantial investment of both time and money. The high costs that result may force the study to be staggered and conducted over a longer period, which can ultimately prevent a delay in understanding a compound’s impact on human beings. Pro: AMDs may be better suited to evaluate the safety of compounds that are intended to alter or ameliorate abnormal physiology The use of CHAs to investigate the potential toxicity or therapeutic benefit of a compound can be problematic. This is due to the realities that:

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