Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and ...

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

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 ...

The introduction of biologicals into our drug armamentarium is complicating stability testing. For these complex molecules neither physicochemical data nor bioassays alone provide the complete picture ...

Qalitex Labs releases industry advisory urging supplement brands to adopt proactive stability testing as global regulations and marketplace standards tighten. Stability testing is no longer optional.

Qalitex warns brands not to rely solely on accelerated stability data, emphasizing need for real-time studies to validate shelf-life and product performance. Accelerated testing gives you a head start ...

Maintaining the required solubility, stability, efficacy and potency of an engineered biotherapeutic protein is critical after its expression in a recombinant system. Analysis and optimization of the ...

Qalitex urges brands to use real-time stability data in post-market checks, warning accelerated studies alone may not reflect true shelf-life. Post-launch, your product's story isn't over. Real-time ...