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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

However, Amgen and other pharmaceutical companies have been criticised when they opted to choose the drug’s dosage based on the MTD model, which is commonly used in dose-finding trials. In 2021, Amgen agreed to conduct a Phase II study (NCT04933695), which is supposed to complete in May 2024, according to Clinicaltrials.gov.

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