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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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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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The rising importance of containment in small molecule drug development

Pharmaceutical Technology

Explaining the rise of HPAPIs, Bruno Villa, CEO, MEDELPHARM believes the trend is a consequence of the increasing pressure on pharmaceutical companies to develop drugs with improved efficiency and efficacy. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated.

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