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Orthotopic Brain Tumor Models Improved with Imaging - Molecular Imaging Inc.

14-Apr-2014 - Know more: enhance in vivo pharmacology with imaging. Recent tumor model development and informative imaging technologies have enabled the efficient and robust use of orthotopic models. These models have proven to be the most clinically relevant and predictive cancer models....
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High Potency Manufacturing - Key selection criteria when evaluating an outsourcing partner - Alkermes

08-Apr-2014 - Many companies are choosing to outsource the manufacture of their highly potent compounds.  A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines elements that should be considered  when outsourcing secondary processing (i.e. dosage form...
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Forecasting strategies to optimize clinical trials - Almac Group

03-Mar-2014 - In a market that is constantly evolving, where rising complexities and costs associated with product development and clinical trial conduct present new clinical supply chain challenges, conventional forecasting methods may not provide an adequate solution.  Add to this the increasing...
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Clinical Document distribution - Secure and Automated - PharmaSOL

08-Jan-2014 - psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user specific escalation paths, with full receipt tracking. Recipients don't have to learn a new system, and your internal overhead is dramatically reduced.psiXchange...
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Joint Risk Assessment During Technical Transfer – A Framework for Donor and Recipient Companies - Alkermes

11-Dec-2013 - Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However all...
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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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HEPATITS C VIRUS – RACE FOR TREATMENT - SGS

23-Sep-2013 - To understand why there is so much buzz in the pharmaceutical world for a better HCV treat­ment, as with most things, you have to start with history. This article will highlight the history, why there is a growing need for...
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Patient Reminders: Improve Retention & Compliance - Cenduit

02-Sep-2013 - The average cost of a patient lost to follow-up is $5,000.  Read on to learn how to incorporate patient reminders into your protocol to reduce cost and resource wastage associated with patient noncompliance and early withdrawal. 
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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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Antibody Drug Conjugate Development and Manufacture - Piramal

03-May-2013 - With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs)are a rapidly growing area in oncology with great potential. Development and manufacture of ADCs can be a challenge with the requirement to handle both biologics...
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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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New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers - World Courier

11-Feb-2013 - World Courier’s newly-expanded international network − now numbering 152 office locations in 52 countries − brings expertise, personnel and infrastructure closer to key customers in Switzerland and Austria with the recent opening of offices in Basel and Innsbruck.At the same...
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The Best of Both Worlds: Swiss Quality, Made in China -

05-Feb-2013 - Lonza brings you the best of both worlds with Swiss quality manufacturing of APIs available at our FDA approved facility in Nansha, China.  From backward integration to tailored production concepts for efficient manufacturing, Lonza offers sustainable solutions for regionally important...
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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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Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain - World Courier

01-Jan-2013 - WORLD COURIER is the market leader in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens in Africa and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge of the local regulatory environment,...
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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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Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho

15-Oct-2012 - The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools...
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Connecting Perfectly At Every Stage - Parexel

30-Jul-2012 - We believe in one bond that's more important than all others. Download our brochure to see how PAREXEL can help to optimize your product value.
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The new product development reality - Parexel

25-Jun-2012 - While winning FDA or other regulatory approval is a formidable hurdle, it is no longer the end game when it comes to defining if the development of a product is truly successful. In today's health care reality, the new finish...

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