Animal Testing, Pharmacokinetics and Small Molecule

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Animal Testing

Pharmacokinetics

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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

FDA

FDA Small Molecule Science Immune Response

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

The Premier Consulting Blog

APRIL 25, 2023

As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models. In this blog post, we examine several alternative approaches to animal testing and how the FDA handles the application of these methods in specific scenarios.

FDA

FDA Animal Testing Pharmacokinetics Small Molecule

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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

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