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3D printing’s breakthrough in the life science market

March 24, 2016 Leave a comment

16661915478_b89cf8096e_qA new item is being introduced into the life science market and it’s getting wide recognition for being the first of its kind: 3D printing. There has been much talk regarding the world of 3D printing but it has not been previously connected with the life science industry. The FDA has approved the first 3D printing drug, produced by Aprecia Pharmaceuticals and its being made to treat seizures and epilepsy.

The 3D pill hit the market earlier this year and questions as to whether the same guidelines apply to the production are arising. When a new drug is introduced, there are several markers that the company must follow, what companies are wondering now is if the same rules apply for a drug that is being 3D printed. Will there be similar guidelines for equipment use and quality control? Quality assurance has been one of the biggest questions surrounding 3D printing in terms of products; with the product now being of a medical background the quality control guidelines are going to be strictly followed and monitored to be sure the product comes out the same as it would under a mechanically generated pill. Read more…

One dead after Phase 1 drug trial in France

January 18, 2016 Leave a comment

er_testtubeA phase 1 drug trial is under scrutiny after one person has died and 5 others are in critical condition following ingestion of the drug. The private laboratory in France, Biotrial, has been testing a pain and mood disorder medication for Bial a Portuguese pharmaceutical company. The drug was a FAAH inhibitor and was supposed to act on the body’s pain, enocannabinoid, system. It had been tested on chimpanzees and just moved to the human phase earlier this month.

A multitude of media outlets have been reporting on the incident and additional details are becoming available to the public.  There are now reports of French prosecutors launching a manslaughter investigation into the unusual case, which shined a spotlight on the practice of testing drugs on paid, healthy human volunteers.
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Steps to reduce the risk of nutraceuticals

October 23, 2015 Leave a comment

pills3Dietary supplements, such as amino acids, vitamins, minerals, and other complementary nutrition products, send approximately 23,000 people in the U.S. to the emergency room each year. A new study published in the New England Journal of Medicine reports that there is legitimate risk associated with taking these supplements.

At the hospitals analyzed in the study, researchers connected 3,667 emergency room visits to supplements. Based on these numbers, the study infers that 23,005 adverse events occur each year across the U.S and adults ages 20 to 34 made up 28 percent of hospitalizations. Weight-loss products were attributed to most emergency room visits per year by women, while visits for men were contributed to body building products or sexual enhancement products. Read more…

The inherent risk surrounding nutraceuticals

May 20, 2015 Leave a comment

pills2Nutraceuticals, a $30 billion industry in the United States, come in the form of capsules, bars, drinks, lotions, pills, and powders. The medical and therapeutic benefits they claim to offer vary from renewed sexual drive, to enhanced athletic performance, to fewer wrinkles. Many are nutritional supplements which, according to JAMA Internal Medicine, were taken by 45 percent of people to “improve” and 33 percent of people to “maintain” overall health. However, only 23 percent of products were recommended by a healthcare provider.

When taking dietary supplements, bear in mind that they are not required to be tested or registered with the United States Food and Drug Administration (FDA). The FDA’s job in oversight is primarily registering facilities, confirming those facilities are operating within proper manufacturing practices, and investigating products after they hit the shelves. Nutraceutical companies may assert that their product has been Read more…