As an editor for Pharmaceutical Technology, I often hear about novel drug-delivery mechanisms. Often they’re high-tech materials such as polymers, hydrogels, or nanoparticles. But a recent Associated Press story revealed a biological-based drug carrier that I hadn’t thought of: fish. Read more »
Archive for the 'Analytics' Category
Yesterday I completed my first vidcast at the AAPS Annual Meeting in Atlanta, Georgia. I had the pleasure of discussing quality by design (QbD) as it applies to analytical methods with one of the top experts in this area: Dr. Moheb Nasr, director of FDA’s Office of New Drug Quality Assessment. Read more »
Erik Gordon, head of biomedical industry programs at Stevens Institute of Technology (Hoboken, NJ) compared Pfizer’s current crush of lawsuits to “having a thousand fleas attack a dog at the same time.” Last week, Pfizer finally decided it was time to lighten the load and the company agreed to settle a huge majority of its lawsuits over its now-withdrawn pain reliever “Bextra” and its still-marketed drug “Celebrex.” Read more »
There’s a new coalition in town and it’s doing a good job of getting FDA’s attention. Here’s the brief back story: USP General Chapter <467> “Residual Solvents” took effect July 1, replacing General Chapter <467> “Organic Volatile Impurities.” In August, FDA issued a related draft guidance, Residual Solvents in Drug Products Marketed in the United States. Since that time, industry has experienced a a number of problems and confusion regarding the draft guidance and communications received from FDA’s Office of Generic Drugs, that seem to conflict with Chapter 467. In fact, there have been so many problems that these core industry groups–IPEC Americas, IPEC Europe, GPhA, CHPA, PhRMA, and SOCMA BPTF—decided to form the Coalition for Rational Implementation of USP General Chapter <467>. Read more »
Researchers at the National Institute of Standards and Technology (NIST) have developed a method for evaluating the stability of protein-based formulations for storage at room temperature, opening the possibility of making this process quicker and less expensive. The researchers presented their findings at the American Chemistry Society’s National Meeting held in Philadelphia earlier this month. Read more »
I’m not an astrologist, but sometimes you have to wonder whether plans were hatched under a bad sign. It certainly seems that way for “Vytorin,” a cholesterol-lowering drug that combines simvastatin and “Zetia.” The drug, introduced by Merck and Schering-Plough, has suffered damaging revelations. Read more »
It’s no secret that industry pipelines are thin at the moment. But what about innovations in pharmaceutical science? Are companies keeping up with the times to develop new ways of testing, delivering, formulating, analyzing, or manufacturing drugs? Pharmaceutical Technology would like to hear from you. In fact, we launched a call for nominations for the 2008 Innovations in Pharma Science Awards earlier this summer. The awards will honor achievements in the pharmaceutical sciences, specifically in these five areas:
1) Drug delivery (solid dosage and parenteral forms)
2) Formulation development (solid dosage and parenteral forms)
3) Dosage-form manufacturing (solid dosage and parenteral forms)
4) Pharmaceutical analysis
5) API synthesis and manufacturing (small molecules and biologics).
But the deadline for nominations is here. Check out this link to nominate your company’s work in one of five areas by next week. The winners will be announced in the December issue.
Researchers and doctors continue to sound warnings about the rise in the number of cases of diabetes, which is closely linked to the increasing proportion of overweight individuals. After a period of decline, the rate of new HIV infections is increasing, reminding us of the gravity of that threat to world health. And the debate about whether cell phones cause cancer has been revived by unsettling new studies.
When we remember that Big Pharma’s pipelines are still generally weak, these troubling facts seem more disturbing. The picture is not entirely black, though. Researchers are hopeful about treatments for at least one medical condition. Read more »