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| | Welcome to the new Drug Delivery Leader newsletter, delivering weekly updates on the latest developments in drug formulation and delivery. Based on your professional interests, we believe you’ll find it useful for staying up to date on regulations, discovering new technologies, learning best practices, and identifying supplier partners. If not, you can unsubscribe at any time. |
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By Fran L. DeGrazio, Strategic Parenteral Solutions LLS | The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches. |
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| Developmental Testing Of IV Solutions | Article | By Ryan Memmer, Singota Solutions | As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration. |
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| Inspection Of Injectable Products For Visible Particulates | White Paper | By John Rech and Ravi Patel, West Pharmaceutical Services, Inc. | Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables. |
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