Drug Target Review

OCTOBER 3, 2024

These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. FDA no longer needs to require animal tests before human drug trials [Internet].

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

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 52

FDA Animal Testing Pharmacokinetics Pharmaceuticals 52

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 40

FDA Science Small Molecule Immune Response 40