An integrated approach to first-in-human trials

Many factors can result in a drug candidate failing at a phase I trial from problems with the actual medicine, such as unforeseen toxicity, or simple logistics and supply chain issues.

Regulators encourage developers to adopt a quality-by-design (QbD) mind-set that places the emphasis on planning and metrics.

Taking a compound from the laboratory to the clinic is a complex process that involves coordinating active pharmaceutical ingredient (API) production with formulation development and trial planning. To make this easier, regulators encourage developers to adopt a quality-by-design (QbD) system where potential challenges are considered from the early stages.

In this Q&A Torkel Gren, Senior Director, Science & Technology Officer at Recipharm discusses the complexities of first in human trials. He explains why an integrated approach that links API production to formulation development, trial management and execution can result in a more effective journey to market.

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