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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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

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Female sexual interest drug reaches tipping point with Phase III plans

Pharmaceutical Technology

Despite the recognized need and demand for options to treat female sexual dysfunction, several safety and access issues associated with the use of available options. Overall, side effects serve as a more significant barrier in this condition than elsewhere because the condition is not life-threatening, says Ben-Zion.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

While new positive clinical data with anti-Abeta mAbs signal tremendous advancement and proof‑of-concept for the whole field, it is believed that the observed effects could still be improved and optimised in terms of greater clinical benefits, lower side effects and enhanced treatment convenience.