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Monthly Archives: March 2020

Drug Scale Up: Planning for Clinical Success

Posted on March 30, 2020 by

Consistent – Yet Still Low – Clinical Success Rates The number of drug candidates which are approved, get to market and subsequently become profitable for industry is pretty low. And…

Posted in API synthesis, APIs, Chemistry, CMC, scale-up | Tagged , , | Comments Off on Drug Scale Up: Planning for Clinical Success

2020 & Beyond – Focus on Pharma Supply Chain (In)Security

Posted on March 15, 2020 by

Over the last four decades, supply chains have gone from being measured in meters to miles – and ultimately to continents & hemispheres. Without a doubt, drug industry globalization has…

Posted in Contract Manufacturing, outsourcing, supply chain | Tagged , | Comments Off on 2020 & Beyond – Focus on Pharma Supply Chain (In)Security

Nitrosamine Impurities and How Companies are Addressing the Crisis

Posted on March 2, 2020 by

We’ve recently written extensively about nitrosamine impurities, including this in-depth analysis of what transpired with Valsartan, and some follow-up material, here and here. Nitrosamine impurities have been receiving a great…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, genotoxic impurities, Quality, Valsartan | Tagged , , , , , | Comments Off on Nitrosamine Impurities and How Companies are Addressing the Crisis