Archive for the 'Analytics' Category

Is Your Lab Ready for New Metal-Limits Tests?

Angie Drakulich PharmTech editorEver since USP released its stimuli article last fall regarding the new, pending General Chapter <231> on Heavy Metals, industry has been up in arms about the proposed changes. Pharmaceutical manufacturers are uncertain of how they are going to move from purely wet-chemistry methods to more complicated, not to mention more expensive, methods such as inductively coupled plasma-mass spectrometry (ICP-MS), graphite furnace-atomic absorption spectrometry (GF-AAS), and cold vapor AAS to test their products for metal impurities. Read more »

Are Facility Inspections a Zero-Sum Game?

Erik Greb PharmTech editorPerhaps out of embarrassment at the stream of incidents involving contaminated products, the US Food and Drug Administration has requested the largest budget increase in its history. The agency intends to use part of the funds for its proposed Safer Medical Products initiative, which will scrutinize domestic and imported drugs. Will it use the money wisely? Read more »

Hope for Bipolar Fish

Erik Greb PharmTech editorAs 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 »

PharmTech’s Vidcasts from INTERPHEX 2009, Part II

Pharmaceutical Technology magazine presents part two of its vidcast program, recorded at INTERPHEX 2009. Click the links below to watch the vidcasts. (Click here to see day one of the vidcast program.) Read more »

AAPS 2008 Coverage :: QbD for Analytics: The How is Now

Maribel Rios PharmTech editorYesterday 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 »

Kids’ Use of Meds Rising

Angie Drakulich PharmTech editorI’ve written about this topic before and I’ll probably continue to do so because it’s a subject close to my heart. The topic has to do with children, health, and medication. Read more »

When Fleas Attack: Pfizer Settles for $894 M

Maribel Rios PharmTech editorErik 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 »

Residual Solvent Concerns Lead to Coalition

Angie Drakulich PharmTech editorThere’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 »

Methods to Evaluate Protein Stability Take a Leap Forward

Patricia Van Arnum PharmTech editor 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 »

Born under a Bad Sign

Erik Greb PharmTech editor

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 »

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