Nitrosamine Impurities in Rifampin – What Does it Mean for Your Drug-Drug Interaction (DDI) Study?

Nitrosamine Impurities
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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Challenges and Successes of ICH Q12 Related Submissions

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, is a transformative document that will shape global regulatory submissions and practices.
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Challenges & Advances in Cleaning Ultrafiltration Membranes

Concentration/Ultra-filtration (CUF) membranes are used extensively in biopharmaceutical operations. A typical purification platform may incorporate two to six CUF steps though out the downstream process.
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cDPI: Line extension with capsule-based inhalation drug delivery

Drug delivery via the inhalation route is currently in demand for treatment of various diseases including asthma and chronic obstructive pulmonary disorders.
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Various ways to implement continuous manufacturing in pharmaceutical development and production

Various ways to implement continuous manufacturing in pharmaceutical development and production
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