Enabling novel paradigms: a biological questions-based approach to human chemical hazard and drug safety assessment

• DOI: 10.1093/toxsci/kfad124
• Publication Date: 2023-12-22T21:47:20Z
• Authors: Brian R Berridge; John R Bucher; Frank Sistare; James L Stevens; Grace A Chappell; Meredith Clemons; Samantha Snow; Jessica Wignall; Kelly A Shipkowski
• Keywords: Scope (computer science)

Abstract Throughput needs, costs of time and resources, concerns about the use animals in hazard safety assessment studies are fueling a growing interest adopting new approach methodologies for product development risk assessment. However, current efforts to define “next-generation assessment” vary considerably across commercial regulatory sectors, an priori definition biological scope data needed assess hazards is generally lacking. We propose that absence clearly defined questions can be answered during primary barrier generation paradigm flexible enough used varying approval decision contexts. Herein, we questions-based (BQBA) facilitate fit-for-purpose method selection more efficient evidence-based decision-making. The key pillars this novel bioavailability, bioactivity, adversity, susceptibility. This BQBA compared with approaches applied scenarios pathobiological understanding and/or testing requirements. To further allow better prediction characterization human health hazard, multidisciplinary collaboration among stakeholder groups should initiated.