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].

52

52

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 100

Clinical Pharmacology Clinical Trials Drugs Trials 100

Advarra

JUNE 20, 2023

Because of this, oncology researchers may only have access to minimal existing scientific literature related to cell-based data and animal testing to predict an investigational therapy’s effect on human factors. Participants may balk at certain protocol requirements, such as extended visits for pharmacokinetic (PK) measurements.

Trials 52

Trials Clinical Trials FDA Approval Animal Testing 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