cGMP and the Role of Pharmacy in Early Phase Clinical Trials

This research article explores the essential functions of pharmacy within Clinical Pharmacology Units (CPUs) during early phase clinical trials. It highlights the importance of adhering to Current Good Manufacturing Practice (cGMP) guidelines, detailing processes such as investigational drug product compounding, dose management, and blinding. The article emphasizes the pharmacist's role in ensuring trial safety, data integrity, and compliance with FDA regulations, showcasing the complexities inv