ICH Stability Testing Requirements for Pharmaceutical and Supplement Products Explained

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA ...
GEN

Stable Ground—The Importance of Stability Testing for Custom GMP Reagents

Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...
FierceBiotech

ADC's accelerated review troubles signal FDA's tough new stance on confirmatory studies

ADC Therapeutics seems to have run headlong into the FDA’s new strict policy on accelerated reviews: Get your confirmatory study in line before filing, or wait. The biotech’s biologics license ...
ksn.com

Qalitex Highlights Importance of Real-Time Stability Testing in Post-Market Surveillance

IRVINE, CA, UNITED STATES, June 20, 2025 /EINPresswire.com/ -- Qalitex Laboratories, a provider of scientific testing and regulatory support services, is advising ...
BioTechniques

Don’t let the case go cold: enabling studies into the protection of aging DNA samples

A new study uses accelerated aging as a method to reduce the duration of studies examining the stability of DNA in forensically relevant biological samples on swabs. A new study from researchers at ...