505(b)(2): It’s A Different Animal
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Technical / white paper
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
Technical / white paper
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.
Case study
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.
Technical / white paper
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.
Technical / white paper
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.
Technical / white paper
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.
Technical / white paper
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...
Technical / white paper
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.
Technical / white paper
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.
On-Demand Supplier Webinar
Diversity for catalysts – assuring speedy and versatile solutions for scale up success - DSM Pharmaceutical Products
03-Feb-2011 -
Wondering how DSM’s unique collection of thousands of catalysts leads to speedy and versatile solutions for scale up success? We will show you how broad chemical and biological diversity increases the chance to successfully identify catalysts
Technical / white paper
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...
Survey
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...
Technical / white paper
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....
On-Demand Supplier Webinar
Micro Reactors - The Future for Cost-Effective Manufacturing - DSM Pharmaceutical Products
26-Aug-2009 -
Leading scientists from DSM speak about micro reactor technology for the sustainable production of API’s to “go green” while introducing cost-effective technologies for process intensification.
On-Demand Supplier Webinar
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...
Technical / white paper
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.
Technical / white paper
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...
