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

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

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...

Before their approval, pharmaceuticals not only have to be tested for their effectiveness and safety, but also for their stability, since they are usually stored in pharmacies and private households ...

Biologics stability testing in pharmaceutical R&D typically requires weeks of waiting between processes. Formulation scientists must develop, assess, and then wait to discover if a formulation remains ...

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 ...

Some medications are unsuitable for one-dose packaging due to issues such as moisture absorption. A survey of community pharmacists was conducted to understand the status of one-dose packaging and ...

Before taking our survey, 16% of respondents were not aware of the CMS regulation and interpretive guidelines that require pharmacists to store drugs and biologicals in accordance with the ...

Understanding antibodies’ structure-function relationship, whether because of sequence modifications or changes in solution conditions, is crucial to understanding how functional changes occur.

Several analytical methods have been reported for the estimation of IMG, including direct UV spectrophotometry 9,10 and chromatographic methods 7,8,11,12,13,14,15. The reported HPLC methods include ...

MilliporeSigma, the U.S. and Canada life science business of Merck KGaA, Germany, says it has launched the first all-in-one, validated genetic stability assay of its kind. The Aptegra™ CHO genetic ...