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External control arms and debunking real-world data myths

pharmaphorum

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. This can require new processes, technologies and an organisation mind shift.”. In both situations, ECAs provide the foundation of comparison between an active treatment population and a control cohort.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. Luckily, even without insurance coverage, this medication is available in generic form and is very affordable, usually costing between $15 to $40 per month. It’s a process and a journey, but it’s definitely worth it.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients.