I was happy to see last week’s FDA column by Dr. Murray Lumpkin on children’s medications. Lumpkin, FDA’s Deputy Commissioner for International and Special Programs, was filling in for Commissioner “Andy” von Eschenbach, who has been writing weekly on the FDA website about current issues. Lumpkin pointed out that, until recently, nearly 75% of medicines used in children did not have prescribing information on how to safely administer or dose medicines for children. Read more »

When process analytical technology was first whispered among pharmaceutical scientists, true visionaries warned manufacturers not to quickly equate PAT principles exclusively with near-infrared spectroscopy. At the time, it was an easy mistake to make. NIR was already poised to be one of analysts’ favorite tools: It’s fast, cost-effective, and provided the clear-cut data quality labs needed. Applications to unit processes such as blending and mixing were already showing up on the exhibit floors; and as a noninvasive technique, NIR seemed ideal. Read more »

As an animal lover—and especially a dog lover—I can understand where PETA, People for the Ethical Treatment of Animals, is coming from when they condemn FDA for not putting an end to toxicity testing on animals. But as a consumer of medication, I also understand the need to test certain things on animals before subjecting humans to potential serious adverse effects. And here lies the challenge that has been around for decades, if not longer, sparking disputes between scientists and those who back ethical treatment across the board. Read more »

It has been a while since the mainstream media has reported on the developments in the fight against avian flu. The facts remain of course that people around the world are still being infected and dying as a result. It is also a fact that the H5N1 virus strains are becoming increasingly pathogenic. The Centers for Disease Control reports “research suggests that currently circulating strains of H5N1 are becoming more capable of causing disease in animals than were earlier H5N1 viruses.” Fortunately, research into new ways to fight the disease continues, most recently as DNA vaccines, which are showing promise. Read more »

To all recent grads: Don’t throw out your calculus books just yet. It turns out that there may be a link between mathematics and curing leukemia. Researchers from the University of Maryland (College Park) and Ecole Superieure d’Electricite (Gif-sur-Yvette, France) have created a mathematical model that uses patients’ individually measured parameters to determine when a dose of a booster “cancer vaccine” should be administered. Read more »

FDA has disqualified more than 130 clinical trial investigators since 1964 for failing to follow certain regulations regarding data integrity and patient safety. Twenty-five of those investigators have been disqualified since 2001, and 7 of them were disqualified in the first half of this year. That doesn’t say much for 2008 as we still have six months to go. Read more »

Various groups have questioned the efficacy and safety of generics lately. That this topic is now being widely debated serves as a reminder that a drug is more than an API. Read more »

Optimizing a method for detecting contaminants in a drug product is critical, and Joe Gecsey, business development manager of life sciences for Hach Ultra Analytics, discussed an approach taken for an inhaled drug product at his presentation, “Analysis of Particle Size and Distribution in a CFC-Free Aerosol Based Pharmaceutical Preparation,” at Interphex. Read more »

As a law in my state, drivers are not “allowed” to pump their own gas. I suppose it has helped the Oregon economy with providing additional (read: low wage) jobs. In turn, our gas taxes may be a little higher than the rest of the country’s. Last week, however, as I pulled up to take another hit to the family budget with another fill-up, I noticed a sign at the station declaring “diesel customers: you are responsible for making sure the right gas is pumped into your vehicle.” Read more »

When I heard on the radio that tests had revealed trace levels of pharmaceuticals in New York City’s drinking water, I was alarmed. I drink a lot of water, and I take it for granted that it’s safe. I assume it’s been filtered, sterilized, treated, and tested so that it’s healthy and innocuous. Read more »