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The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

The 1938 law effectively changed the focus of the Food and Drug Administration (FDA) from a policing agency to a regulatory agency tasked with overseeing the safety evaluation of new drug products. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. percent or 1,000 ppm.

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Dr B raises $8m for telehealth service to deliver COVID antivirals

pharmaphorum

It will provide a low-cost online consultation and prescription medicine service to patients, starting with the two oral COVID-19 antivirals – Pfizer’s Paxlovid (nirmatrelvir/ritonavir) and Merck & Co’s Lagevrio (molnupiravir) – which are authorised for at-home use by the FDA.

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

NMR relaxation methods distinguish between components (phases or compounds) that have different molecular mobilities For monoclonal antibodies, identification methodologies can employ chromatography, spectroscopy, isoelectric focusing, capillary electrophoresis and peptide mapping techniques. 2007; 66(11-12): 963–8. Cited 2023Feb].

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Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

pharmaphorum

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. And all are predominantly prevented or treated with medicines that are decades old. Innovation will power the market.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

You may be familiar with naltrexone, which is an FDA-approved medication that has been used since the 1980s for opioid withdrawal. The first article was published in 2007, and it showed LDN as an effective and safe therapy for Crohn’s disease. [4] It needs to be compounded into lower doses by a professional compounding pharmacy.

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Can you use metronidazole for cats?

The Checkup by Singlecare

In humans, metronidazole is FDA-approved for treating certain bacterial infections. Although not FDA-approved for animals, metronidazole is used off-label in cats when prescribed in veterinary medicine. A compounded medication is excellent for cats who refuse to eat food mixed with the medicine or become uncooperative.

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Contamination Trends & Proposed Solutions

ISPE

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.