Archive for the 'Analytics' Category

Better Quality Could Mean Fewer Drug Shortages

Erik Greb PharmTech editor

Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. Read more »

Could Wild Gudgeon Be Canaries in a Coal Mine?

Erik Greb PharmTech editor

Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »

QbD in Theory and Practice

Erik Greb PharmTech editorThe pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

FDA Follows EMA toward Follow-On Biologics

Erik Greb PharmTech editorDuring this cost-conscious time, many patients and other healthcare payors are opting for generic versions of branded pharmaceuticals. Biopharmaceuticals have claimed a place in the spotlight, but the US currently has no regulatory pathway for biosimilars. That could change after FDA releases its final guidance on follow-on biologics later this year. Read more »

Requirements for Extractables & Leachables Can be Confusing, to Say the Least

Angie Drakulich PharmTech editorIt’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.

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Heavy Metals Contamination a Problem for McDonalds, Pharma

Alexis Brekke Pellek PharmTech editorLast week’s McDonalds glassware recall is another example of the problem of heavy metals appearing in consumer products. The fast-food giant, in cooperation with the Consumer Product Safety Commission (CPSC), recalled its promotional Shrek glassware because of the elevated level of cadmium found in the glasses. Read more »

The US Treasury Shows R&D Scientists Some Love

Erik Greb PharmTech editorResearch and development (R&D) scientists may have been feeling down in the dumps lately. Many of them have lost their jobs in the last few months as a result of mergers and cost-cutting projects. But these sometimes underappreciated workers may soon get more respect, thanks to a US government initiative. Read more »

Swine-Flu Vaccine Recall Only Adds to Panic

Angie Drakulich PharmTech editorAs if the US community isn’t already paranoid enough about the H1N1 swine flu virus and its vaccine, this week, Sanofi Pasteur, the vaccines division of the sanofi-aventis Group in France, recalled 800,000 prefilled vaccines.

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Dark Horse or Albatross?

Erik Greb PharmTech editorReading the news sometimes gives me a disorienting sense of déjà vu. I felt it again when I read that Ranbaxy (Gurgaon, Haryana, India) had recalled a batch of its acne drug isotretinoin after the US Food and Drug Administration found that the product’s dissolution-test results were out of specification. Didn’t this happen once before? Read more »

USP Makes More Decisions on Heavy Metals Proposals

Angie Drakulich PharmTech editorIn the latest news regarding the US Pharmacopeia’s proposed limits and test changes for heavy metals, the organization is expected to post new information on its website regarding its plans to revise General Chapter <231> based on its June 2–3 USP PNP stakeholders meeting. Read more »

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