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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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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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Mounjaro generic availability, cost, and more

The Checkup by Singlecare

In the case of Mounjaro , the pharmaceutical company Eli Lilly holds a patent for both the medication and its injection delivery device. Dosage Mounjaro is FDA approved as a weekly injection from a prefilled autoinjector pen. Dosages are standardized, with a starting dose of 2.5 When will a generic Mounjaro be available?

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Rising demand for pediatric dosage forms requires reformulation, expertise, and to-scale manufacturing capabilities

Pharmaceutical Technology

Pharmaceutical companies are looking to paediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. Various modifications to adult dosage forms (ADFs) are often needed to make a drug easier for children to take and easier for parents to administer. Innovative solutions to complex challenges.

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Examining the 505(b)(2) Pathway and Implementation into EHR

Pharmacy Times

A panelist discusses how the 505(b)(2) regulatory pathway provides a streamlined approval process for modified versions of previously approved drugs, allowing pharmaceutical companies to rely partly on existing safety/efficacy data while still requiring new clinical data, commonly used across various therapeutic areas including reformulations, new (..)

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Sustainability continues to steer pharmaceutical packaging market

European Pharmaceutical Review

[Analysis from the study reported Europe to be] the “dominant” region in the pharmaceutical container market” Europe was described as the “dominant” region in the pharmaceutical container market, and a “preferred choice” for sustainable packaging because of the region’s “established recycling infrastructure”.

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Flomax generic availability, cost, and dosage

The Checkup by Singlecare

Sanofi manufactures brand-name Flomax capsules, while various pharmaceutical companies, including Sun Pharmaceuticals, Impax Laboratories, and Teva Pharmaceuticals, manufacture generic Flomax capsules. Flomax ( tamsulosin ) Uses Treatment of enlarged prostate (BPH) symptoms Standard dosage 0.4

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What to know about semaglutide weight loss

The Checkup by Singlecare

Novo Nordisk is the only pharmaceutical company that makes FDA-approved medications containing semaglutide. Regardless of dosage, it takes time for the medication to reach a steady state in the body. Ozempic and Wegovy dosage can be increased after four weeks on the starting dose.