Episode notes
This episode introduces the crucial first stage of clinical trials where a new drug is administered to humans for the very first time. We explore the primary objectives of Phase 1 trials, which are to assess safety, determine safe dosage ranges, and understand how the drug is processed in the human body (pharmacokinetics). The discussion also covers the importance of ethical considerations, particularly informed consent, and the selection of participants, often healthy volunteers. Real-world protocols and case studies are referenced to illustrate how these principles are applied in practice, emphasizing the meticulous planning and monitoring involved in these initial studies. The episode aims to demystify this critical step in drug development, highlighting its importance in laying the foundation for all subsequent research.
Beyond safety, ...