2009, Animal Testing and Pharmacokinetics

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2009

Animal Testing

Pharmacokinetics

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. §

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

Drug repurposing: The benefits, risks and what we learned from Covid-19

Drug Discovery World

JULY 20, 2023

Pharmacokinetic and pharmacodynamic modelling in mice and allometric scaling should be used to refine dose strengths for human studies, and the available safety data may need re-evaluating considering predicted dosages. She urged that new methodologies are needed to reduce human and animal testing to establish safety and efficacy.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Trials

Drug Discovery Digest

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

Drug repurposing: The benefits, risks and what we learned from Covid-19

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