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Driving Dosage Form Developments

PharmaTech

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

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With little FDA oversight, melatonin supplements vary widely in actual dosage, study finds

STAT

WASHINGTON — Consumers turning to melatonin gummies to get some help falling asleep might be getting a lot more help than they bargained for, according to a new study published Tuesday in the Journal of the American Medical Association.

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STAT+: Lawmaker accuses Amgen of placing profits above patients with dosing for a cancer drug

STAT

At the time, the Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval. Continue to STAT+ to read the full story…

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Reshaping Dosage Forms

PharmaTech

Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

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STAT+: Oral ketamine tablets effective for treating depression, new study finds

STAT

In the Phase 2 trial, the results of which were detailed in Nature Medicine , patients who took extended release ketamine tablets at an 180mg dosage twice weekly showed a “statistically significant and clinically meaningful improvement in depressive symptoms” compared to a placebo. Other dosages saw less of an impact.

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Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes

PharmaTech

The full tolerance coverage method is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

Dosage 98
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STAT+: Pharmalittle: We’re reading about copycat weight loss drugs, ADHD prescriptions spiking, and more

STAT

Telehealth firms and pharmacies instead intend to sell versions of the obesity drugs tailored for specific patients whose doctors say they need a different dosage than one of the original drugs or a version with extra vitamins added.