ProPharma’s Post

Discover the FDA's Animal Rule, enabling life-saving drug development through animal studies. Learn how ProPharma guides sponsors through regulatory requirements for success. #DrugDevelopment #FDA #AnimalRule

Discover the FDA's Animal Rule, enabling life-saving drug development through animal studies. Learn how ProPharma guides sponsors through regulatory requirements for success. #DrugDevelopment #FDA #AnimalRule

Discover the FDA's Animal Rule, enabling life-saving drug development through animal studies. Learn how ProPharma guides sponsors through regulatory requirements for success. #DrugDevelopment #FDA #AnimalRule

Discover the FDA's Animal Rule, enabling life-saving drug development through animal studies. Learn how ProPharma guides sponsors through regulatory requirements for success. #DrugDevelopment #FDA #AnimalRule

Discover the FDA's Animal Rule, enabling life-saving drug development through animal studies. Learn how ProPharma guides sponsors through regulatory requirements for success. #DrugDevelopment #FDA #AnimalRule

Discover the FDA's Animal Rule, enabling life-saving drug development through animal studies. Learn how ProPharma guides sponsors through regulatory requirements for success. #DrugDevelopment #FDA #AnimalRule

Did you know that the FDA authorized alternatives for animal testing in drug discovery in december 2022? This was the first step in the pursuit of a more ethical and safe research. And what better way to produce test models for R&D than 3D bioprinting using human cells? Check this article from Science to understand the context around this new legislation and what the future might have in store for us (we definitely have something in store... soon!) 👀

Do not miss this article on the misleading role of animal models in drug development. This article highlights the increasing use of Integrated Approaches to Testing and Assessment (IATAs) as a more ethical and scientifically sound alternative to traditional animal testing in drug development. IATAs strategically combine results from multiple new approach methodologies (NAMs), such as computer models, cell cultures, organ chips, and lower animal species, to replace or reduce animal use. However, despite the advancements in these alternative methods, animal studies are still required in certain areas of research. This is because cell cultures and computer models cannot replicate the full complex biology of a living organism. Animal testing provides invaluable data about real-world efficacy and safety that often cannot be obtained by other means. The use of animal models can be minimized through the intelligent combination of advanced models with computational approaches, which offers a path to enhanced predictivity of human outcomes. IATAs do not necessarily avoid animal tests completely, but they do strategically combine new methods to significantly reduce and refine animal use. The challenges for IATAs include determining the best test combinations, assessing predictivity, validating integrated approaches, and obtaining regulatory acceptance. Despite these challenges, IATAs represent a pragmatic approach to transition from an animal-centered paradigm to more human-relevant 21st century toxicology, thereby making research more ethical and potentially more accurate in predicting human outcomes. #toxicology #NAMs #3Rs #testing #invivo #invitro #alternativemethods

This article highlights the need of safety testing and the complexity of it, the risks with putting too much trust in animal testing despite the differences to humans. “a balanced approach that acknowledges both the value and the limitations of animal studies will be essential in advancing drug development.” As lifted up, there are fantastic new methods under development with potential of both reducing animal testing and increase safety.

📢 Great news: EVI-led project #VAC2VAC contributes to reducing #AnimalTesting! The European Pharmacopoeia is discontinuing the rabbit pyrogen testing. 🐰🚫 The EVI-led VAC2VAC project (www.vac2vac.eu) was key in replacing it with an in vitro alternative for vaccine against tick-borne encephalitis virus (TBEV). This development not only highlights the importance innovative approaches in pharmaceutical testing, but also strengthens our commitment to ethical #vaccine development and quality control, ensuring safe and effective vaccines for everyone. 🌍🔬 Read more ➡ https://lnkd.in/d8-jVVS7 --- VAC2VAC is IMI funded project. Innovative Health Initiative (IHI) #VaccineDevelopment #SustainableScience #3Rs European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe