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Highlights
Seeking Chemocatalytic and Biocatalytic Solutions
Advances in palladium-catalyzed hydrogenation, visible-light photocatalysis, and chemocatalyisis for heterocycles are some recent developments.
Facilitating Efficient Equipment Cleaning
Equipment design and cleaning procedures both play a role in thorough sterilization and cleaning.
A More Rational Approach for Sterile Product Manufacturing
The authors assert that the current gulf between aseptic processing and terminal sterilization can be bridged by re-examining fundamental regulatory philosophies for sterile-product manufacturing.
Using Closed-Vial Technology in Aseptic Filling
Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.
Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector
This paper examines the process of gamma irradiation of plastic materials used as part of single-use disposable systems in the pharmaceutical and biotechnology sectors, with a focus on validation requirements.
Suppliers eDirectory
See who's showing at 2011 industry exhibitions
pharmtech corporate capabilities 2012
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Parallel Trade Fuels UK Drug Shortages
Single-use Systems Proliferate
Report on Recent and Upcoming Single-Use Meetings
ICH Q11 Reaches Harmonization, Implementation is Next
Digital Signatures Growing as a Result of Part 11

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Industry Leaders: Q+A
Q&A with Erik van den Berg, AM-Pharma
A Q&A with Erik van den Berg, CEO of AM-Pharma, on recent industry trends.
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Regulatory Corner
Standards & Regulations
FDA Perspectives: Scientific Considerations of Forced Degradation Studies in ANDA Submissions
The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions.
Regulation and Compliance
Q&A with David Elder of Strategic Compliance Consulting, PAREXEL International. Elder is a former senior official with FDA.
FDA Explores Options to Expand Access to Non-Rx Drugs
Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.
FDA Details Strategies for Addressing Globalization
A new report by FDA details the strategies, programs, and other activities the agency is using to address the rise of imported pharmaceutical products and APIs.
Jim MillerOutsourcing OutlookJim Miller Channeling Steve Jobs
Patricia Van ArnumIngredients InsiderPatricia Van ArnumSeeking Chemocatalytic and Biocatalytic Solutions
Nathan JessopIndustry InsiderNathan Jessop Taxing Times for French Pharma
Lynn D. TorbeckStatistical Solutions Lynn D. TorbeckRepresentative Sampling
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