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In today’s pharmaceutical industry, Quality by Design (QbD) has become an essential – instead of optional – tool. In fact, the phrase, “essential instead of optional” reminds me of the…
In the pharmaceutical discovery space, many promising analytical trends have emerged and are now on the rise – and they will see increasing use in drug discovery in coming years….
A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…
In a recent issue of PharmTech, Agnes Shanley wrote an article on the specialty markets and services driving the growth of APIs in which we were featured. For me, the…
With everything involved in bringing a drug to market, enlisting the services of an experienced CMO can prove to be a very worthy investment. Ideally, the relationship between a pharma…
7 ways to boost profits and reduce pharma synthesis waste At Neuland, we’re advocates of green chemistry. Not only is it better for the environment, but it’s also just logistically…
Sometimes I feel like I come across as a bit too “QA crazy,” but quality in the pharma sense isn’t really something of which you can have too much. From…
Impurities and the ICH Limits for Impurities Impurities are unwanted chemicals produced during normal manufacturing of Active Pharmaceutical Ingredients, or APIs. As you well know, impurities have no therapeutic value…
