Quality by Design (QbD) principles are now fast migrating to the analytical laboratory and the generic pharma community offered up some excellent real-life examples last week at the IFPAC annual meeting in Baltimore, MD.
The session was chaired by Lawrence Yu, FDA which helped give this session the attention it deserved.
A senior Director at Teva, described how statistically rigorous QbD principles can be put into practice in order to provide more robust method development, validation and transfer.
Also, both Amneal Pharmaceuticals and Prinston Pharmaceuticals continued the theme with very comprehensive case studies …

Welcome to the second blog in the“Molecules of Note” series on Malvern’s Materials Talks blog site. Last time we extolled the importance of (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid, better known as Lipitor.
This month’s molecule of note is Galanthamine, a drug used to treat Alzheimer’s with an unusual derivation, being synthesized from the snowdrop flower. According to one historical account, a Bulgarian pharmacologist was visiting a rural area, on the outskirts of Sofia, around 1950 when he saw people rubbing snowdrops on their foreheads to ease headaches, and his curiosity was aroused.  It is …

Despite the fanfare, guidance documents from ICH and the world’s regulatory agencies, a plethora of conferences, much discussion on various social media sites and a good number of examples for QbD implementation, there is little published about where industry really stands with regards to adopting and implementing QbD.
So, it was very interesting to read the FDA’s more robust stance for full implementation of QbD, by the generic pharmaceutical industry, when filing an abbreviated new drug application (ANDA).  As the much anticipated January 2013 deadline looms, is the generic pharmaceutical industry …

A few friends and I are planning a “learn to cook” vacation in Italy next spring. Being competitive by nature and to ensure I don’t appear a complete novice, I have become obsessed with cooking the perfect pasta. From Agnolotti to Zitoni, it feels like I have made and cooked them all.
So, what is my definition of perfect pasta? The perfect pasta should be slightly al dente, not soft or gummy. It will be sticky enough to hold sauce, but not so sticky that it sticks to itself. It set …

The first three years of life are extremely influential when it comes to a child’s development. Research has shown that there are “critical windows” for different mental abilities, many of which occur during that early developmental period. Once a given brain region has passed that window, the opportunity to “rewire” it is significantly limited.
Nurturing a new drug product through discovery, development and finally to manufacturing is very much the same.  There are “critical windows” during the development process that are important to the evolution of a pharmaceutical with the desired …

Welcome to a new series on Malvern’s blog site, “Molecules of Note”. Think of this column a little bit like those articles you read in the newspaper supplements of papers such as New York Times, The Daily Telegraph, The Times of India, China Daily that effuse about great wines, cheeses or other globally revered comestibles. Whether it be through blogs, tweets or good old print media, I don’t think that truly great molecules get enough air-time. Well, all that’s about to change. Read on.
Here’s the first homage to one of …

How do you make the Lincoln Memorial, the Venus de Milo, The Taj Mahal and the Great Wall of China disappear? 
Ask a pharmaceutical formulation scientist.
It is reported that around ninety percent of new chemical entities discovered by the pharmaceutical industry today are poorly soluble compounds, as are some 40% of drugs currently on the market. Rendering the drug formulations soluble has been described to me, by some pharmaceutical scientists, as “trying to dissolve the Lincoln Memorial” or the Venus de Milo, or Taj Mahal, or the Great Wall of …