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Compendial Globalization: Achieving Harmonization through Standardized Practices and Collaboration
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| By
J. Mark Wiggins
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Howard D. Schneider, Jr.
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The authors discuss a new approach to address globally harmonized compendial standards.
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Managing Product Supply Risks
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| By
Sushil Abraham
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How to use geographic diversification and legacy technology transfers to avoid product shortages.
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Costs of Failure in Product Quality
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| By
Satish Asotra
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Alexander Cossin
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Avraham Yacobi
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The authors detail the possible consequences of noncompliance and a lack of quality control.
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Product Quality Lifecycle Implementation
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Bruce Davis
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Ranjit Deshmukh
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John Lepore
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Line Lundsberg-Nielsen
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Roger Nosal
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Stephen Tyler
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Chris Potter
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The authors provide an overview of the new ISPE Guide Series on Product Quality Lifecycle Implementation and how the guides can be used in a complementary way with existing guidance from FDA and the International Conference on Harmonization.
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Gaining a Pulse on Formulation and Drug Delivery Challenges and Technologies
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Patricia Van Arnum
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A recent survey examines the industry's views on the chief challenges and technologies in drug delivery and formulation development.
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Inside INFORMEX: Evaluating the Market for Contract API Manufacturing
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Patricia Van Arnum
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Contract API manufacturers and fine-chemical producers roll out capacity and service expansions.
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Evaluating Impurities in Drugs (Part III of III)
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| By
Kashyap R. Wadekar
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Ponnaiah Ravi
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Mitali Bhalme
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S. Srinivasa Rao
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K. Vigneshwar Reddy
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L. Sampath Kumar
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E. Balasubrahmanyam
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In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.
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Report from China
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Jane Wan
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China's drug-distribution network has been a mess for years, but government reforms and industry focus are unveiling new opportunities for market order and growth.
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Regulation and Compliance: Deviation Investigations
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Q&A with Peter Smith and David Elder, Strategic Compliance Consulting, PAREXEL International, on acceptable deviation investigations. Smith and Elder are both former senior officials with FDA.
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Loose Lips Sink Ships
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| By
Control, a senior compliance officer
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Failure to disclose info may work sometimes, but eventually every question will be answered.
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A Sustainable Biotech Path
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Glen Giovannetti
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With financing constrained, biotechnology firms must find ways to sustain innovation.
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Scoping out INTERPHEX
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| By
Hallie Forcinio
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Visitors will see many packaging innovations at the annual industry exhibition.
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Representative Sampling
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| By
Lynn D. Torbeck
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Understanding the differences between convenience, target, and self-selected samples.
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Know the Regulations
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| By
Susan J. Schniepp
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The contract provider needs to know as much as the NDA holder.
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