The Evaluation of Animal Models in the Development of Anticancer Agents: From Preclinical to Clinical Tests
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Updated: Feb 6, 2026

Kidney Procurement in a Preclinical Large Animal Model
Published on: May 2, 2025
Jie Wang1, Haiyan Dong2, Jian Liu1
1Cancer Metastasis Alert and Prevention Center, and Biopharmaceutical Photocatalysis, State Key Laboratory of Photocatalysis on Energy and Environment, Fujian Provincial Key Laboratory of Cancer Metastasis Chemoprevention and Chemotherapy, Fuzhou University, Fuzhou 350002, China.
Background:
One of the main reasons for most of the anticancer drugs to fail in the late preclinical testing and early clinical trials is the differences in drug effects observed from animals and patients, and the challenge has been to find a balance to reduce the inherent differences from species.
Objective:
Predicting safe starting doses and dosing schedules for human clinical trials is the main purpose of toxicological studies of anticancer drugs.
Methods:
Relevant information and data were assimilated from manuscripts, congress publications, and online sources.
Results:
We systematically overview the cons and pros of animal models and briefed the ways to determine human clinical starting doses derived from animal toxicological studies for anticancer drugs.
Conclusion:
This information helps smart select the suitable predictive model for anti-cancer drugs with the different mechanisms and emphasized the pharmaceutical challenges behind and ahead.
Insights
Selecting appropriate animal models is crucial for anticancer drug development. This review overviews animal model limitations and methods for determining safe human clinical starting doses from toxicological studies.
Area of Science:
- Pharmacology
- Toxicology
- Drug Development
Background:
- Anticancer drug development often fails due to interspecies differences in drug effects between animals and humans.
- A significant challenge is balancing these species-specific variations to improve predictive accuracy.
Purpose of the Study:
- To predict safe starting doses and dosing schedules for human clinical trials of anticancer drugs.
- To guide the selection of appropriate animal models for preclinical anticancer drug testing.
Main Methods:
- Systematic review of existing literature, including manuscripts, congress publications, and online data sources.
- Assimilation and analysis of relevant toxicological data from various preclinical studies.
Main Results:
- Comprehensive overview of the advantages and disadvantages of different animal models used in anticancer drug research.
- Detailed explanation of methodologies for deriving human clinical starting doses from animal toxicological data.
Conclusions:
- Informed selection of predictive models for anticancer drugs with diverse mechanisms of action.
- Highlights key pharmaceutical challenges and future directions in preclinical anticancer drug development.
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