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Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic Measurements
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| By
John P. Jasper
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Larry E. Weaner
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John M. Hayes
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The authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.
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The Advantages of Restricted-Access Barrier Systems
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Johannes Rauschnabel
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Filling machines often are installed in sterile rooms and separated by isolators to prevent contamination. These methods have certain drawbacks, including making interventions more difficult. Restricted-access barrier systems are an alternative that ensures sterility and facilitates interventions.
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Shifting Patterns in Sourcing
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Patricia Van Arnum
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The pharmaceutical supply chain lengthens as generic drug manufacturers build production platforms offshore and CMOs position in India and China to meet demand for lower-cost production.
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Big Shot: Developments in Prefilled Syringes
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Brianne Harrison
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Maribel Rios
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Many companies are coming up with innovative materials and manufacturing methods to feed the growing demand for prefilled syringes.
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Pfizer Restructuring a Boon to CMOs and CROs
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Jim Miller
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As big pharmaceutical companies restructure and reevaluate the way they do business, contract research and manufacturing organizations could reap greater financial rewards.
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Maintain Your Moving Parts
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| By
Control, a senior compliance officer
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Just because the wheels are turning doesn't mean they're going forward.
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Accelerating Drug Development
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Jill Wechsler
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FDA's new safety program, Critical Path Initiative, and user-fee proposal seek to reinvigorate pharmaceutical R&D.
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Packaging Trends
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Hallie Forcinio
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Security, the environment, aging populations, the bio-boom, and cost control are just a few of the drivers that will influence pharmaceutical packaging for the remainder of this decade.
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What Will It Mean to the Patient?
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Douglas McCormick
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Before we can intelligently set the limits of process variation, we need to know what the clinical impact of that variation will be.
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Pursuits of Business
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Maribel Rios
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The Parenteral Drug Association recently held its first global conference on emerging manufacturing technologies. Among the presentations were those discussing the latest in disposable technologies, aseptic filling and closing, and barrier systems. Clearly, technology vendors have stepped up efforts to streamline processes and better handle complex drug products.
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March 2007
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The proposed rule would impose new record-keeping requirements on some 1200 manufacturing establishments.
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