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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+: 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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Reshaping Dosage Forms

PharmaTech

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

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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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STAT+: Airway disease drug from Insmed succeeds in one of the year’s most anticipated trials

STAT

The trial, called the ASPEN study, tested two dosages of the drug, and the company said both significantly cut rates of pulmonary exacerbations.     The drug, brensocatib, reduced so-called pulmonary exacerbations by roughly 20% versus placebo in patients with bronchiectasis, hitting the trial’s primary endpoint.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

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