Newsletter | December 10, 2024

12.10.24 -- Should We Explore Suicidality In Animals During Preclinical Drug Development?

FEATURED EDITORIAL

Should We Explore Suicidality In Animals During Preclinical Drug Development?

An adverse side effect for some drugs is suicidal ideation and behavior (SIB). Investigating SIB in animal studies represents the closest approximation to human SIB, yet the FDA Modernization Act 3.0 obligates us to reduce unnecessary animal testing. Let's examine this with data-driven research.

Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies

The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.

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