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 ...
The FDA has announced a nationwide recall of more than 11,000 bottles of chlorthalidone, a medication commonly prescribed to ...
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 ...
The alternative text for this image may have been generated using AI. The absorption of a drug substance after oral administration of a solid dosage form depends primarily on its release from the drug ...
Many months after Phathom Pharmaceuticals won FDA approval for vonoprazan as part of two combinations to treat Helicobacter pylori infection, the drugmaker is still unable to launch the product. Back ...
Understanding antibodies’ structure-function relationship, whether because of sequence modifications or changes in solution conditions, is crucial to understanding how functional changes occur.
DDL, a third-party testing laboratory, is pleased to welcome Jennifer Riter as Vice President of Analytical Testing to spearhead GMP testing and drug-device combination products consulting services.
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