Proactive Safety Management for Established Healthcare Products

Jan 8, 2014

A recent analysis shows that more than $290 billion of prescription drug sales are at risk from patent expirations between 2011 and 2018. Chitra Lele at Sciformix discusses why patent expirations is on the rise and organizations focusing on market expansion opportunities, substantial penetration of generic medicinal products in both developed as well as emerging markets, is now a clear trend in the industry. ...

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Critical Thinking on Criticality

Jan 7, 2014

“Critical” is a widely used term in Quality by Design, relating to anything which affects the safety or efficacy of the finished product. Dr. Brian Carlin at FMC BioPolymer explains why Critical Process parameters and Critical Material Attributes must be controlled to ensure the finished product Critical Quality Attributes necessary for safety and efficacy, as prospectively summarized in the Quality Target Product Profile. ...

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Discovery Toxicology Services

Jan 7, 2014

Toxicology the study of poisons, determines whether a drug can be used on humans. Almost 30% of clinical trial attritions are attributed to the toxicological profile of a molecule. The patent cliff’s drying pipelines are driving the fail early and are failing safe practices in the drug development process. Meenakshi L at Beroe Inc., provides an overview of discovery toxicology and how this is being outsourced by the large pharma in bits and pieces owing to lack of efficiency in-house. ...

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Improving and Refining Models of Acquired Resistance for Efficient Oncology Drug Discovery

Jan 7, 2014

Conventional chemotherapy has been, for many years, the prevalent type of anti-cancer treatment. However its broad-based mechanisms, DNA alkylating agents, usually lead to severe systemic side effects.  Dr. Rajendra Kumari at Precos Ltd, looks into how today the treatments inhibiting specific molecules that have a role in tumour growth or progression have become successful.  http://ipimediaworld.com/wp-content/uploads/2014/01/Improving….pdf ...

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