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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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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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Novel nanoemulsion-based delivery of antimycobacterial drug

European Pharmaceutical Review

A paper has a described the first reported use of nanoemulsions as a novel delivery vehicle for the oral drug bedaquline (BDQ) “with high loading efficiency as a liquid dosage form”, according to the authors. Notably, the “highly lipophilic” properties of BDQ make it “an ideal candidate for formation into a lipid-based drug delivery system”.

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. 

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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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Training Centers and eCommerce: A Look Into Federal Equipment Company’s Pharma Innovations

PharmTech

How the trade tariffs are fueling the shift back to oral solid dosage (OSD) products like tablets and capsules. Learn more about: Techceuticals and PharmParts, value-add businesses that focus on novel technologies, comprehensive training, and simplicity for CDMOs.

Dosage 52
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Blister material as a source of nitrosamine impurities

European Pharmaceutical Review

The investigation was launched after NDMA and NDEA were detected in a finished dosage form, though neither were identified in the bulk drug product. With blister packaging among the most commonly used packaging type for pharmaceutical products worldwide, the findings could have significant implications for industry.

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Gabapentin dosage for dogs by weight

The Checkup by Singlecare

The standard gabapentin dosage for dogs is 5-30 mg/kg up to three times daily. However, the dosage can vary by condition. Below is a chart of gabapentin dosage for dogs by weight. Gabapentin dosage by weight for dogs Weight Starting dosage Max dosage 5-10 lbs. How often can I give my dog gabapentin?

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