Archive for the 'Analytics' Category

Time is Running out for Innovation Awards

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.

 

 

Comfort for the Afflicted

Erik Greb PharmTech editorResearchers 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 »

More Pediatric Research a Must

Angie Drakulich PharmTech editorI 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 »

Raman Breakthrough without Breaking Through

Maribel Rios PharmTech editorWhen 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 »

Animal Testing for Drug Safety: A Necessary Evil?

Angie Drakulich PharmTech editorAs 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 »

Fighting Avian Flu with DNA

Maribel Rios PharmTech editorIt 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 »

Math Therapy

Maribel Rios PharmTech editorTo 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 »

Researchers Disqualified, But Still Working on Drugs

Angie Drakulich PharmTech editorFDA 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 »

More Than Meets the API

Erik Greb editor PharmTechVarious 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 »

Particle-Size Analysis for Inhaled Drug Products

Patricia Van Arnum Pharmtech editorOptimizing 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 »

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