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PCI Pharma Services Announces Further Expansion in San Diego to Maintain Industry-Leading Quality, Service and Flexibility

Philadelphia, PA – June 4, 2019 PCI Pharma Services (PCI), a leading biopharmaceutical outsourcing services provider, has announced the growth of its West Coast Clinical operations with expansion into its third facility in San Diego.
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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Clinical Innovation Partnerships

11-12 September 2019, Hotel Palace, Berlin

Clinical Innovation Partnerships is the only event for senior clinical operations and procurement professionals driving innovation in their clinical trials. It is where the pharma, CRO and vendor clinical trials ecosystem meet to drive innovation in digitalisation, tech and partnering to improve patient experience and reduce trial cost and time.
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