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Protecting the Public
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| By
Hallie Forcinio
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Overt and covert packaging technologies evolve to authenticate drugs and fight counterfeits.
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Optimizing Early-Stage Drug Development
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Patricia Van Arnum
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Pharmaceutical companies and contract service providers adapt strategies and capabilities to reduce costs and accelerate drug-development timelines.
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AAPS Workshop Summary
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| By
Dilip R. Choudhury
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Ramesh K. Sood
,
John Bobiak
,
Mark Alasandro
,
Steven W. Baertschi
,
Bekki Komas
,
M. J. Skibic
,
Brian W. Pack
,
Saji Thomas
,
Robert H. Seevers
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Kim Huynh-Ba
,
Stephen Colgan
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A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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EU Sets Guidelines for Biosimilar Monoclonal Antibodies
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| By
Sean Milmo
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The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).
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Examining the Growing Challenge of Extractables and Leachables
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Stephanie Sutton
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Experts share insight into extractables and leachables testing, including high-risk products, analytical testing, and regulatory requirements from FDA and EMA.
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Knowledge is Power
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Angie Drakulich
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Global tactics that incorporate online technologies and social media are reshaping disease response.
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ISPE Annual Meeting Seeks to Foster Global Change
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Nancy Berg
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At the inaugural joint FDA/ISPE conference on CGMP earlier this year, CDER Dirctor Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt QbD principles must be a top priority.
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Frozen Assets
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| By
Control, a senior compliance officer
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Even when all is well at the facility, one must expect the worst while braving the elements.
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Q&A with Yves de Montcheuil of Talend
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A Q&A with Yves de Montcheuil, vice-president of marketing at Talend, a provider of open-source integration software.
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Report from Turkey
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Sean Milmo
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The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.
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A New Risk-based GMP Inspection Planning Tool
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| By
Kevin O'Donnell
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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has finalized a risk-based inspection planning tool for inspectorates to use in applying science- and risk-based principles to planning GMP inspections.
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