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Learn the risk factors of metabolic syndrome and the role central labs play in aiding its detection - ACM Global Central Laboratory

17-Jun-2014 - Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected and treated. The key risk factors of metabolic syndrome were identified approximately 250 years ago. However, there...
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A year on, EU GDP’s affect on European Pharma Distribution - World Courier

24-Mar-2014 - World Courier welcomed the EU GDP guidelines, which created a yardstick by which logistics providers could be measured and compared.  A year on from the draft publication it is now fully in force and there has already been an update...
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SERIALISATION - Recipharm AB

17-Mar-2014 - Recipharm already has experience in serialised production. From our UK facility in Manchester over 40 batches have been delivered from a fully validated line to the Turkish market since 2010.Serialisation is a complex area and the requirements are likely to...
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Ensuring cold chain remains cold and controlled room temp remains controlled! - World Courier

24-Feb-2014 - The first of ten new vehicles have been delivered to World Courier Ground Europe, and in line with the requirements of the regulations for pharmaceutical distribution have undergone qualification testing for frozen, refrigerated and controlled room temperature conditions at extreme...
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Controlled Release and Bioavailability Enhancement -

28-Oct-2013 - Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: •    Customized Controlled Release Drug Delivery •    Bioavailability Enhancement •    Taste Masking (liquid and solid presentations)When applied appropriately, these technologies can deliver therapeutic and convenience benefits to...
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New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy - Baxter

17-Oct-2013 - Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been developed. However, in recent years it has become obvious that some of these rules need modification. In this presentation,...
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(b)(2) or not (b)(2)? That is the question. - Camargo

19-Aug-2013 - 505(b)(2) is more than a regulatory pathway - for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. So, is (b)(2) for you? To find out...
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Pharmaceutical Development for ADCs - Baxter

05-Aug-2013 - Formulation, process, and analytical development for ADCs is complex. While an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution...
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Avoid Angry Customers-Eliminate Defects - METTLER TOLEDO

12-Jun-2013 - In the pharmaceutical business, it is crucial that containers be free of contamination, formation defects and dimensional irregularities to avoid the risk of product contamination. As a result, pharmaceutical companies must have strict quality standards and robust inspection programs. Vision...
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Supply Chain Issues and Trends in Asia - Marken

02-May-2013 - Import/export of biological samples from China China: Large Pharma Reverse Logistics A Common Issue: Destruction of Drug in Taiwan J-GMP: How is GMP different in Japan? Korea: Biosimilars Hotbed India: Will Regulations Change to Allow Quicker Study Approval in 2013?
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Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI - Almac Group

21-Jan-2013 - Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac provide a real life overview of their unique inhaler blinding services which have been successfully developed and validated,...
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Alkermes successful approach to commercial-scale, final dosage manufacture of drug product containing highly potent API for a global pharmaceutical company. - Alkermes

18-Dec-2012 - As part of Alkermes plc, Alkermes Contract Pharma Services, provides solid oral dosage product development, scale–up and manufacturing services as well as sterile fill finish capabilities to the global pharmaceutical market. This case study demonstrates how a commercial manufacturing partnership...
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Lyophilized Pharmaceuticals: A Design Space Approach - Baxter

29-Oct-2012 - This presentation by Steven Nail, PhD and principal Scientist for Baxter BioPharma Solutions, discusses development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm.
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TLM Pharma – Packaging Line for Vials - Schott Relations GMBH

11-Jun-2012 - A Russian customer is currently packing 20 different packages on his new TLM pharma-machine. They are packed with various vials in packaging boxes with differing content.
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A Clinical Perspective on IV Medication Delivery - Baxter

09-Apr-2012 - Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists.  The information provided reflects research conducted assessing medication delivery practices and preferences.
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The Scientific Path to Cycle Development - Baxter

20-Feb-2012 - To optimize lyophilization cycle times and improve stability for complex injectables, Baxter’s BioPharma Solutions contract manufacturing business established the Lyophilization Center of Excellence, an industry-leading resource for development of high-quality freeze drying.
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Container Testing: Quantifying Metal Contaminants - SGS

18-Oct-2011 - Regulatory Agencies have clearly established the need to identify and control harmful chemicals which may leach from container closure systems into the final packaged drug product. But USP <661> colorimetric methods for detecting heavy metal contaminants are known to be...
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Extractables and Leachables in Pharma - Solvias AG

06-Jun-2011 - Extractables and Leachables are a hot topic in pharma. Learn more why this is of concern and how testing for leachables as well as extractables should be conducted.
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The 10 Essential Don’ts for Manufacturers to combat Main Street’s ‘New Normal’ and win - CDC Software

10-Sep-2010 - Many factories are currently engaged in many cost reduction initiatives that are stumbling or have dramatically slowed down. In many cases they continue because received wisdom supposes that they must deliver a benefit otherwise we would not be doing them....
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Beyond Plant Visibility to Business Improvement - CDC Software

17-Aug-2010 - Increasing evidence is pointing to the realization that many plant-wide intelligence initiatives do not lead to the dramatic improvements that the business wants and needs. This Cambashi Analyst White Paper discusses five major factors that producers must incorporate into their...

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