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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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Footprint-Free™ Cell Line Engineering Services at Transposagen -

13-Feb-2014 - Altering the genome of cells is a powerful and increasingly necessary tool for drug discovery and research. Transposagen utilizes its expertise and a diverse portfolio of gene editing tools including XTN™ TALENs, CRISPR nickases, as well as piggyBac™ transposons, for...
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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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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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Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials - Marken

07-Aug-2013 - Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider a DTP solution. Included in the discussion are concerns with the traditional distribution channels, advantages and challenges...
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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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ePathology Improves Data Accuracy & Study Productivity! – Amicus Study Confirms - Aperio

20-Mar-2013 - With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization or site, meant that slides had to be packed, shipped and tracked. Often the reading pathologist was required to...
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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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Analytical Method Development and Validation — A CDMO Perspective - DPT Labs

28-Nov-2012 - Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug...
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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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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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Targeted Product Development: Personalized Medicine versus Orphan Product Development - Rho

31-Jul-2012 - The development of therapeutics for personalized medicine leverages many of the advantages of the legislation conferred upon orphan products. New products must be positioned intelligently to take advantage of this legislation. Join David Shoemaker, Ph.D. as he discusses the benefits...
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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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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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