N-Nitrosamine impurity findings in marketed formulations of rifampin have disrupted drug development. As a strong cytochrome P450 3A4 (CYP3A4) inducer, rifampin was regularly co-administered with investigational products
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Compounds that are poorly soluble in water are still prevalent in the pharmaceutical industry drug development pipeline.
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In this webinar, Anders Högdin, Senior Sales Director at Recipharm discusses the common challenges companies encounter during upscaling. He also outlines the key considerations during the medicinal and process chemistry planning phases, the regulatory requirements and the steps companies can take to streamline the process.
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Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products.
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