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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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White Paper: Is My Method Still Valid? - SGS

26-Mar-2013 - The goal of method validation is to pro­vide proof that data from each individual sample is indicative of the actual batch content with little deviation. This paper outlines the importance of validation as well as the official requirements, including characteristics...
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Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing - SGS

03-Dec-2012 - Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtain results that accurately represent the sterility status of a batch. Download this article for the best practices
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INFLUENZA TREATMENT CLINICAL TRIALS: CLINICAL CASE STUDIES - SGS

19-Nov-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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Extractables & Leachables Risk Assessment - SGS

22-Oct-2012 - An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European manufacturing plant for 40 finished products, resulting in a global testing plan.
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Biosafety Testing: In Vitro Virus Detection - SGS

09-Oct-2012 - Regulatory authorities (US FDA and the EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines and vaccines.One area of concern is that the cell substrates used in the production of...
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New Early Phase Concepts: Practical Implementation - SGS

03-Sep-2012 - There is an urgent need to use innovative techniques in early development. This paper will discuss several case studies in which new clinical trial methods were employed during the early phase clinical development of therapeutic compounds.
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Enhanced Rheumatoid Arthritis CIA and CAIA Studies - Molecular Imaging Inc.

23-Jul-2012 - Detect disease modification with biomarker imaging using PET, FMT & CT to assess treatment response. Enhance decision making with complementary end points minimized histopathology Improve your next RA Study–contact us at marketing@molecularimaging.com
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Vaccine-Based Clinical Trials - SGS

09-Jul-2012 - Download this paper to read two case studies which illustrate strategies for planning and implementing a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
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Implementing LEAN Techniques in Quality Control - Baxter

17-Apr-2012 - Applying LEAN techniques can result in improved productivity, workflow efficiency and cost savings. The Quality Control Laboratory at Baxter’s contract manufacturing facility in Halle/Westfalen, Germany, has been applying LEAN techniques since 2007 with the goal of reducing release lead times....
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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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Ensuring Quality & Regulatory Compliance w/ Service Providers - DPT Labs

25-Jan-2012 - In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure...
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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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Characterisation of Biopharmaceutical Proteins -

14-Nov-2011 - Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. This paper describes the array of the more common techniques used in...
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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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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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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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Opportunities in Oncology Clinical Trials in Latin America - Intrials Pesquisa Clinica LTDA

27-Jul-2011 - Clinical trial in Oncology involves one of the most expensive and complex protocols in a research environment. For the past few years, Latin America has been included in the scenario of this study area due to its patient’s recruitment potential,...