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Industry Events

Clinical Trials Europe | Partnerships, Outsourcing, Operations & Technology

27 August - 21 November 2019, Barcelona, Spain

On 19-21 November 2019, the clinical trial community's most influential stakeholders will be meeting in Barcelona to discuss the evolving landscape, honing in on what it takes to harness true value from partnerships, outsourcing, operations, technology and early clinical development, for a faster, more efficient route to market.
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News and Press Releases

MedPharm Expands Relationship With Novan On Formulation Science

MedPharm Ltd, a leader in topical and transdermal drug delivery, has expanded its relationship with the NASDAQ listed biopharmaceutical company Novan Inc. MedPharm has previously supported Novan by testing the companyís unique formulations using its proprietary in vitro models to optimise Novanís formulations and de-risk product development.
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White Papers

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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