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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…
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…
The International Council for Harmonisation (ICH) is an organization which brings together the pharmaceutical industry and regulatory authorities to improve the synchronization of industry regulations. The organization’s ultimate goal is…
Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…
2020 is here and we’re starting the New Year off right. We’re listening closer to – and learning more from – you, our customers. Last November’s CPhI Frankfurt provided valuable…
At just about the same time we were going to write on the state of peptides (key takeaways: yes – still growing, lots of promise, more drugs in the pipeline),…
Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…
In July, the United States and European Union finalized a Mutual Recognition Agreement (MRA) for drug manufacturing inspections. Both parties have now fully implemented the MRA for specific therapeutics in…
Why is there a growing preoccupation with particle size? It’s because particle size can alter the efficacy (e.g., bioavailability) and safety profile (e.g., toxicity) of a compound. Complex particle sizing…
Soluble drug APIs are now the exception, not the rule. An article at PharmTech by Felicity Thomas (Looking Beyond the Solubility Horizon) caught my eye recently as it discussed a…
