Case Study

Maximizing Drug Formulation for First-In-Human Trials

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Maximizing Drug Formulation for First-In-Human Trials

The manufacture of a drug product for clinical trials is of critical importance. The formulation, manufacturing, and assessment of a drug candidate during first-in-human (FIH) trials can be contributing factors in whether the drug safely provides the correct dosage and gains regulatory approval. An integrated approach, which combines formulation development, GMP manufacturing, release testing, and clinical testing, has been proven to shorten timelines, reduce costs, and improve flexibility.

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