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Meeting the challenges of complex drug substances - Vetter Pharma International GmbH

15-Apr-2014 - Realizing the full potential of an injectable drug compound is no small task. In the months and years that lead from the discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can slow development...
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Preparation of Pharmaceutical Samples for Metals Analysis -

28-Nov-2013 - With proposed changes to elemental impurities requirements for pharmaceutical products currently being reviewed, spectroscopic techniques for metals analysis are being widely discussed. The preparation of the samples is often overlooked,  this is a  critical step in producing good quality analytical...
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METHOD VALIDATION – USP PROPOSED <233> - SGS

05-Nov-2013 - The USP is continuing to modify a proposal for using inductively coupled plasma (ICP) and ICP-mass spectroscopy (ICP-MS) to detect contaminating heavy metals in drug products. The new USP <233> describes testing methods to detect elements of interest specifically, accurately...
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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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Nucleic Acid Amplification Technique for Biosafety - SGS Life Science Services

23-Sep-2013 - Use of cutting-edge NATs reduces the amount of time needed for development and safety testing of novel biotech products. This white paper describes specific NAT applications including the detection of contaminating viruses, mycoplasma & mycobacteria.
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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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Endpoint Based Protocol Development: A Central Laboratory Perspective - ACM Global Central Laboratory

20-Jun-2013 - The ability to ensure that relevant and accurate laboratory testing is performed, which will meet the primary and secondary endpoints in a clinical trial, is the basic expectation for any central laboratory. Pharmaceutical and biotech organizations, along with CROs continually...
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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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