Revolutionizing Drug Discovery: The Rise Of Fashionable Models
The Federal Food, Drug, and Cosmetics Act of 1938 required animal testing for all new drug development protocols to ensure safety and efficacy prior to human trials. However, this approach is increasingly scrutinized due to ethical concerns surrounding animal welfare and doubts about its effectiveness in accurately predicting human responses.
As a result of recent research technology advancements, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. These models eliminate the need for animal testing, as they offer reliable safety and efficacy assessments for therapeutics.
The emergence of viable animal testing alternatives prompted a significant shift in legislation, culminating in the FDA Modernization Act 2.0 which was signed into law in December 2022. This act authorizes the use of non-animal testing methods for drug and biological product applications, marking the start of an ongoing transformation in drug discovery towards more ethical and innovative approaches. Continue reading to explore the potential, challenges, and future perspectives of organoid and OoC technologies.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Biosimilar Development? Subscribe today.