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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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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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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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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. End-to-end continuous processes flow from starting materials to finished dosage forms.

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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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A Systemwide Approach to Managing the Risks of Continuous Manufacturing

ISPE

Advanced technologies such as CM have the potential to greatly transform pharmaceutical production processes by improving drug quality and supply continuity for consumers worldwide while benefiting the company’s bottom line. Supply Chains of Quality Pharmaceuticals.” Office of Pharmaceutical Quality (OPQ) White Paper.