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Webcast: New Strategies for Evaluating BioPharmaceutical Stability (May 9) Sponsored by ABC Labs Webcast: New Developments in Chromatography for Improved Analytics of Biopharmaceuticals (May 14) Sponsored by Thermo Fisher Scientific Webcast: Trends in Safe Handling of Potent Compounds in Pharmaceutical Manufacturing Processes (May 15) Sponsored by Patheon Webcast: The Basics of Biosafety Testing for Biologics (May 21) Sponsored by SGS Webcast: Minimizing Out-of-Specification (OOS) Errors Using a Risk-based Gravimetric Approach (May 22) Sponsored by Mettler-Toledo More Webcasts 2013 PDA/FDA Glass Packaging Conference May 15-16, 2013 Bethesda, MD USA World Biotechnology Congress 2013 June 3-6, 2013 Boston, USA Late Stage Pharma Lifecycle Management June 4-5, 2013 Brussels, Belgium Advertisement: Avoid the 483–Unconventional Approaches to Elevate Your Quality Program Live Webcast: Thursday, May 23, 2013 at 8:00am PDT/ 11:00am EDT Click Here to Register Free Advertisement: Pharmaceutical Technology Drug Delivery Guides A three-volume set of drug delivery system handbooks. A compilation of articles on methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects.Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. Click here

May 9, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE Fine-Chemical Producers Make Targeted Investments Contract API manufacturers proceed with select investment in capacity and service additions. Advancing Flow Chemistry in API Manufacturing Continuous flow chemistry offers potential for greater control, improved safety and environmental profiles, and efficient chemical transformations. Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards The development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs is summarized. Advertisement: New Cold Chain Compliance Kit: The regulations and standards for temperature controlled supply chains are broad These four Application Notes will help you cover your bases: FDA & ICH Regulations & Standards PDA Technical Report 39 USP Guidelines ISTA Profiles & Standards Plus – bonus Webinar: "Temperature Logging for Cold Chain Operations" Download the kit... Tamiflu Leads Q1 Drug Sales Growth In the first quarter of 2013, the rankings for the top five drugs by sales shifted a bit, but exhibited positive growth for the quarter, according to a report released by Drugs.com. Pfizer Opens Online Pharmacy to Fight Counterfeit Medicine Pfizer has launched a prescription-fulfillment website for Viagra tablets in an effort to combat the online sale of counterfeited medicine. Advertisement: Live Webinar – Integrating Risk & Quality Management in Life Sciences – May 23 Join us and LNS Research as together we conduct a deep dive on the role of risk and compliance in quality management, providing benchmark research from a recent LNS Research study of over 100 life sciences companies, including the best practices for managing risk and compliance.Learn more and register now. PhRMA Dismayed by Special 301 Report PhRMA has expressed dismay that the Office of the United States Trade Representative’s (USTR) 2013 Special 301 Report did not grant an out-of-cycle review for India. Advertisement: FREE WHITEPAPER: The Key to Tableting Success Learn about common pitfalls, critical questions to ask your tooling provider, and the basics of tool steel selection. Learn More! Bayer to Acquire Conceptus for US$1.1 Billion Bayer announced that it has signed a merger agreement with US-based birth-control specialist Conceptus. Advertisement: Trends in safe handling of potent compounds in pharmaceutical manufacturing processes Live Webcast: Wednesday, May 15, 2013 at 11:00 AM EDT. Register Free at www.pharmtech.com/trends Actemra Receives FDA Approval for Polyarticular Juvenile Idiopathic Arthritis Genentech announced that FDA has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in children aged two years and older. Advertisement: A Pragmatic Application of QbD: Turning Theory into Tangible Success Register Free at www.pharmtech.com/pragmatic Pharmaco-Kinesis Corporation Develops First Nanodrug Combination for Glioma Pharmaco-Kinesis Corporation announced that it is developing the first nanodrug combination of Merck's temozolomide and Celgene's thalidomide (in a 50:50 ratio) for the treatment of gliomas and other cancers. Advertisement: Cleaning Validation: Science, Risk, and Novel Approaches to Testing Live Webcast: Tuesday, June 4, 2013 at 11:00 am EDT Register Free at www.pharmtech.com/testing Advancing QbD in the EU The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines. Read More Manufacturers Under Pressure to Manage Painkillers Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations. Read More Trends in GMP Violations FDA's Brian Hasselbalch provides an overview of trends found in FDA quality inspections over the past year. Read More Advertisement: New Strategies for Evaluating Biopharmaceutical Stability Live Webcast: Thursday, May 9, 2013 at 2:00 pm ET. Register Free at www.pharmtech.com/biostability

What has been the most significant benefit of applying quality-by-design (QbD) principles? Better process understanding: 67%   Increased efficiency or reduced waste 9%       Shorter process times 5%       Reduced expenses 4%       Improved ease of making changes 15%       This week we would like to know... How does your company apply quality-by-design (QbD) principles to manufacturing processes? Contact Us Click here to contact editorial. Click here to contact sales.

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