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Journal of Development in Bioengineering and Biosciences

Published

Preclinical Drug Development: Application Of Advanced Models And Predictive Methods In Safety Assessment

Published in (April-June 2026) (Vol. 1, Issue 1, 2026)

Preclinical Drug Development: Application Of Advanced Models And Predictive Methods In Safety Assessment - Issue cover

Abstract

Preclinical drug development faces inherent limitations associated with conventional models, such as two-dimensional cell cultures and animal models, which exhibit limited physiological relevance and contribute to high attrition rates in clinical phases. NAMs, including human organoids, organ-on-chip systems, microphysiological platforms, physiologically based pharmacokinetic modeling, omics technologies, and artificial intelligence, provide an integrated and predictive framework for the assessment of organ-specific toxicities, mechanistic characterization, and human extrapolation. These tools enable dose optimization, improved risk monitoring, and reduction in animal use. Nevertheless, challenges remain regarding functional maturation, experimental reproducibility, regulatory validation, and population representativeness. The strategic and combined application of NAMs constitutes an advanced preclinical ecosystem that complements traditional approaches and holds significant potential to enhance the safety and efficacy of drug candidates in development.

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Authors (1)

Victoria Montes Gimeno

Universitat de Lleida

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Article Information

JDBB110001

JDBB-01-000001

1-17

2026-04-27

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How to Cite

Montes, V., (2026). Preclinical Drug Development: Application Of Advanced Models And Predictive Methods In Safety Assessment. Journal of Development in Bioengineering and Biosciences, 1(1), 1-17. https://jdbb.technomedjournals.com/articles/JDBB110001

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