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Weight of Evidence: Is an Animal Study Warranted? Assessments for Carcinogenicity, Drug Abuse Liability, and Pediatric Safety. | LitMetric

AI Article Synopsis

  • * The course aimed to teach participants how to write regulatory documents using the weight of evidence (WOE) approach for specific safety assessments like carcinogenicity and pediatric safety.
  • * The manuscript covers important data elements, strategic options, and real case studies, along with insights from the US FDA regarding dossiers that include WOE arguments.

Article Abstract

Nonclinical safety studies are typically conducted to establish a toxicity profile of a new pharmaceutical in clinical development. Such a profile may encompass multiple differing types of animal studies, or not! Some types of animal studies may not be warranted for a specific program or may only require a limited evaluation if scientifically justified. The goal of this course was to provide a practical perspective on regulatory writing of a dossier(s) using the weight of evidence (WOE) approach for carcinogenicity, drug abuse liability and pediatric safety assessments. These assessments are typically done after some clinical data are available and are highly bespoke to the pharmaceutical being developed. This manuscript will discuss key data elements to consider and strategy options with some case studies and examples. Additionally, US FDA experience with dossier(s) including WOE arguments is discussed.

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Source
http://dx.doi.org/10.1177/10915818241259794DOI Listing

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