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Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery
Published on: March 4, 2021
Toxicology in the drug discovery and development process
Michael A Dorato1, Lorrene A Buckley
1Lilly Research Laboratories, Greenfield, Indiana, USA.
Current Protocols in Pharmacology
|February 2, 2012
Summary
Drug development relies on toxicology studies to assess candidate safety using animal models. Understanding these studies is crucial for predicting human risk and ensuring drug safety.
Area of Science:
- Drug Development
- Toxicology
- Preclinical Safety Assessment
Background:
- Toxicology studies are essential for evaluating the safety of new drug candidates.
- Animal models and validated procedures are used to assess potential risks.
- Translating animal data to human risk assessment is a key challenge.
Purpose of the Study:
- To outline the objectives and scope of toxicology studies in drug development.
- To highlight the importance of understanding international guidelines and various toxicology models.
- To detail the components of a typical toxicology profile.
Main Methods:
- Utilizing relevant animal models and validated procedures.
- Adhering to international guidelines for safety evaluation.
- Employing traditional and nontraditional toxicology models.
Main Results:
- A comprehensive toxicology profile includes safety pharmacology, genetic toxicology, and various exposure studies (acute, subchronic, chronic).
- Studies encompass absorption, distribution, metabolism, and excretion (ADME), reproductive/developmental toxicology, and carcinogenicity assessment.
- The process aims to establish a safety profile for potential drug candidates.
Conclusions:
- Toxicology studies are fundamental to ensuring drug safety before human trials.
- A thorough understanding of diverse toxicology methodologies is vital for accurate risk assessment.
- The integrated approach provides a robust evaluation of a drug candidate's safety profile.
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