On average, it takes 10-15 years and 1-2 billion dollars to approve a new pharmaceutical for clinical use. Since approximately 90% of new drug candidates fail in clinical development, the ability to make early, informed and accurate decisions on the safety and efficacy of new hits and leads is key to increasing the chances of success.
How do I set up my processing method to calculate the RRT of the main peak to 10kD in karat 32 software?
The pharmaceutical industry is facing an ongoing issue with genotoxic impurities (GTIs). Over the past year, we have witnessed genotoxic impurities affect several drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. Angiotensin II...
In our previous blogs we discussed the need for a more comprehensive approach for monitoring contaminants in finished drug products.1,2 Here we cover a generalized approach for the targeted, quantitative LC-MS/MS analysis of several commonly encountered nitrosamines in pharmaceuticals and ways to address specific challenges with their analysis.
In my previous blog, I spoke about the FDA recall of angiotensin II receptor blockers like losartan. This recall was due to the presence of genotoxic nitrosamines. Is a proactive approach the way to mitigate risk? Recently, the FDA has re-issued the 2018 guidance to...