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4 ways ex vivo models offer Pharma better alternatives to animal testing

Reprocell

Pharma companies are legally required to test novel drugs in animal models before beginning human trials. And while animal testing has progressed thousands of therapeutics that we use today, it is not without its experimental and ethical downfalls.

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Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects

FDA Law Blog: Biosimilars

using phantoms, ex vivo animal tissue models, and/or in vivo animal testing), computationally, and/or clinically. When in vivo animal testing is needed, tests should follow good laboratory practices and the animal model should be representative of the intended clinical application.

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Advanced 3D cell-based technologies

Drug Target Review

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0.,

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A therapy candidate for fatal prion diseases turns off disease-causing gene

Broad Institute

However, with a strong therapy design and promising laboratory results in hand, the researchers have good reason to be hopeful. They continue to work at full throttle, intent on developing their technology so that it can save patients’ lives not someday, but as soon as possible.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Most notably, preclinical research can be distinguished by their need for a series of extensive laboratory testing performed on non-human models, such as cell cultures and animals. Conclusion In conclusion, the roles of preclinical and clinical CROs are distinct but equally important in the drug development process.

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The essential role of recombinant phage display antibody libraries

Drug Target Review

Moreover, ethical considerations regarding the use of laboratory animals further complicate the use of primate polyclonal serum, and successful immunisation is not always guaranteed. FDA no longer needs to require animal tests before human drug trials [Internet]. 1975 Aug;256(5517):495–7. Antibodies to watch in 2024.

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Raising Welfare for Lab Rodents

Codon

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

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