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American Pharmaceutical News In Review
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March 19, 2020
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  How Modern Informatics Technologies Improve Pharmaceutical Stress Testing

The goal of pharmaceutical stress testing, or forced degradation, is to compile degradation pathways so that all relevant degradation products are detectable. This field has experienced significant recent advancement, fueled in part by the development of informatics systems to support stress testing approaches.

This whitepaper outlines several notable examples of such platforms, including ACD/Labs’ Luminata™, which represents a powerful tool to enable complete analytical data management and decision support for various chemistry, manufacturing, and controls (CMC) applications, including forced degradation. Get more info and read white paper.


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» Industry News
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  FDA Issues Guidance for Conducting COVID-19 Clinical Trials
The FDA issued a guidance for industry, investigators and institutional review boards conducting ... read more »
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  Provention Announces Positive Data from Lupus Treatment Study
Provention Bio announced positive top-line results from the Phase 1b portion of the PREVAIL study ... read more »
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  Biohaven's Verdiperstat Receives Fast Track Designation for Multiple System Atrophy Treatment
Biohaven announced verdiperstat received Fast Track designation from the FDA for the treatment of ... read more »
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  Diatherix Eurofins Launches SARS-CoV-2 Virus Identification for COVID-19
Diatherix Eurofins has developed a test for the SARS-CoV-2 virus, the cause of the COVID-19 ... read more »
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  AcelRx to Acquire Tetraphase
AcelRx announced a definitive merger agreement to acquire Tetraphase in a stock for stock deal. read more »
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  Contec Launches Virtual Training Tool Sensitive to Social Distancing
Contec has accelerated the launch of its online learning and training tool, VAL™. read more »

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» Featured Articles
Nitrosamines in Pharmaceuticals: Toxicity, Risk Analysis, Chemistry, and Test Methods
Nitrosamines are a well-known group of highly potent, mutagenic impurities formed by the reaction of... read more »
The CDMO’s Challenges for Developing Oral Suspensions for Children
Since the Pediatrics Regulation enforcement in Europe in 2007, and in 2003 in the U.S., it is now ... read more »
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» Featured Video
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  Watch Video: Introducing the SKANFOG SPECTRA
Watch Video: Introducing the SKANFOG SPECTRA watch »
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  Watch Poster Video: Validation of design features and method reducing risk of false positives during bioburden filtration testing
In this poster, Zahira Perez discusses the validation of design features and method reducing risk of false positives during bioburden filtration ... watch »

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» Featured Products
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  Facility Monitoring System
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  CHIRALPAK ZWIX - Immobilized Zwitterionic CSPs
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» Featured Whitepaper
Solutions to Today’s Biomanufacturing Challenges
With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new ... read more »
eBook: Implementing Microbial Analysis Technologies for World-Class Production
This eBook covers microbial testing, analysis, and monitoring technologies and strategies to ensure world-class pharmaceutical production. Article cover topics such as data integrity issues, ... read more »

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| Events
EVENT
  INTERPHEX 2020
New York, NY –  07/15/2020
For 41 years, INTERPHEX has proven to be the place to find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture ...
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EVENT
  CPhI North America
Philadelphia, PA –  04/20/2021
Over the last three years, CPhI North America has brought together more than 15,000 industry professionals across the entire pharmaceutical supply ...
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