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SGS-Clinical-Influenza Clinical Trials… - SGS

02-Apr-2012 - Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview of challenges faced when conducting an influenza treatment study based on two recently managed clinical trials. 
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Sample Prep Proposed USP<233> Elemental Impurities - SGS

27-Feb-2012 - Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the test article may not be the primary factor when choosing a sample preparation method.
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How to Approach Identification of Anomalous Peaks - SGS

22-Feb-2012 - The sudden appearance of an unknown peak during an HPLC analysis of a pharmaceutical product can be a critical finding causing delays and requiring considerable resources to resolve. The unknown peak can be caused by many things ranging from simple...
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New Challenges in Early Clinical Development - SGS

24-Jan-2012 - With many new challenges in early clinical development there is pressure to change how early phase clinical trials are conducted where the final goal is to shorten the time to go-no-go decisions and decrease cost. It is increasingly important to...
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Glycosylation of Proteins: Structure & Analysis - SGS

06-Dec-2011 - Glycosylation is one of the most widely observed, and structurally diverse, forms of post-translational modification of proteins and glycans have been shown to have a range of specific biological roles. Mass spectrometry-based techniques provide an extremely powerful tool for glycan...
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Improving Signal Detection in Drug Safety - SGS

07-Nov-2011 - Early identification and management of emerging drug safety issues are a major concern of industry stakeholders. Electronic capture systems for AE reporting now allow for faster accumulation of data and the ability to perform complex analysis.
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White Paper: Vaccine-Based Clinical Trials - SGS

26-Sep-2011 - Download this paper to read two case studies which illustrate strategies for planning and implanting a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
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Protein & Glycoprotein Characterization by MS - SGS

30-May-2011 - This paper gives the essential background to understanding biopharmaceutical characterization by mass spectrometry and its importance in accelerating the processes leading to the approval of new drug products, including mAb’s, hormones, cytokines
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Are you getting the right bioavailability and bioequivalence data for inhalation products you’re developing? - DPT

15-May-2011 - Consider the risk to your development program of not accounting for patient variation in device handling. In this webinar DPT Labs and Proveris Scientific team up to demonstrate how the Ergo system can help you develop the right actuation parameters...
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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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Exploristics supports the Design and Validation of Clinical Rating Scales, Patient Reported Outcomes, Composite Endpoints and Quality of Life Data - Exploristics

25-Aug-2010 - Quality of Life, Patient Reported Outcomes, Composite Endpoints and Clinical Ratings Scales have important applications in clinical research and practice. These instruments provide vital measures of the effectiveness of treatment as well as the general well-being and physical and psychological...
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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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Generate Sales Leads: Free White Paper - William Reed Business Media

02-Aug-2010 - White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and establish your company’s reputation as a thought leader. Want to know how to create an effective white paper? Download William...
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Are you Asking the Right Questions? - William Reed Business Media

02-Aug-2010 - Want to evaluate your company’s brand image or the opinion of the Outsourcing-Pharma readers on a certain topic? Want to perform a market research analysis without the hassle? Download William Reed Business Media’s survey brochure to find out how you...
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Method Development and Validation of Caffeine and Paraxanthine in Human Plasma - BASi

10-May-2010 - BASi’s expanded European facility provides contract research services — preclinical, toxicology, bioanalytical, method development and pharmaceutical analysis — as well as, specialized instrumentation for electrochemistry and in vivo sampling products. BASi focuses on developing innovative services and instrumentation that increases...
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Generate sales leads with a good white paper - William Reed Business Media

24-Mar-2010 - White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and improve your company’s reputation as an expert. Want to know how to create effective white papers? Download this guide now....
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Understanding The 505(b)(2) Approval Pathway - Camargo

27-Jan-2010 - By the time he founded Camargo Pharmaceutical Services in 2003, Ken Phelps had already amassed more than 30 years of experience in the health science and services industry. With a broad background in drug development, specifically the 505(b)(2) regulatory approval...
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Camargo Pharmaceutical Services – 505(b)(2) Used for the Approval of New Drugs - Camargo

23-Sep-2009 - Historically, the 505(b)(2) pathway is used for modifications of approved drugs. Yet, regulations state that a new chemical entity can also be approved under this FDA approval pathway. Camargo experts will discuss this process at the CHI: Drug Repositioning Summit,...
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Webinar - Meeting the Challenges of Biosimilars Characterization - Solvias AG

16-Jul-2009 - Generic biologics offer the prospect of cheaper medicines, however exact copies of innovator biological drugs are not possible. A review of analytical requirements, challenges, and the lessons learned will be presented.
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Shoot for share: from vial to pre-filled syringe - Baxter

08-Jul-2009 - Pre-filled syringes are a growing alternative to vials for many of today’s parenteral products. According to recent estimates, the market for pre-filled systems is expected to top 2.4 billion by 2010. The increased interest in pre-filled syringes is in large...
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Increase your webinar performance with expert tips and advice - William Reed Business Media

24-Jun-2009 - Learn how to maximize registrations and retain viewer attention for your webinars. Get expert advice and tips from the online marketing solutions team at William Reed Business Media. After you attend this free web seminar, you will know how to...
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Publish your Technical Paper on this Website - William Reed Business Media

09-Jun-2009 - Promote your company’s technical expertise towards decision makersPublish your Technical Paper on this website.
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Second sourcing: A strategy to mitigate supply chain risk - Baxter

28-May-2009 - Supply chain risks are growing: Less inventory slack Longer supply lines Greater exposure to global political and financial events Industry experts Jim Miller of PharmSource and David Shuey of Willis HRH lead a discussion of pharma business risk and its’ management in order to...
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Harmonized Pharmaceutical Microbiology: SGS Technical Bulletin - SGS

01-Jul-2008 - For many years now, microbiologists in Europe, Japan, and the US have been separately assuring the purity of pharmaceutical products and raw materials with specific techniques accepted in their respective compendia. The results generated from these differing procedures are generally...