Maximizing drug formulation for first-in-human trials

May 22, 2024

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The primary goal of first-in-human (FIH) trials is to establish the initial dosage of a new drug, ensuring it is low enough to minimize safety and toxicity risks while allowing for the highest effective dosage for the trial. The production of the drug for clinical trials is crucial, as the formulation, manufacturing, and evaluation during FIH trials can significantly influence the drug's safe dosage and eventual regulatory approval. Early phase development decisions in a clinical research setting yield valuable insights for later phases. Integration is essential—efficiently incorporating clinical data into the manufacturing process significantly aids in achieving marketing approval.

An integrated approach, combining formulation development, GMP manufacturing and release testing, and clinical testing workflows, has been shown to shorten timelines and enhance decision-making. This method allows initial drug batches to be produced, tested, released, shipped to the clinical site, and administered to subjects within days. This real-time, adaptive manufacturing strategy is applied throughout the early drug development cycle, enabling live clinical data to guide decision-making.