Drug Development and Ethical Principles

This lecture covers the historical aspects of drug development, regulatory agencies, and ethical principles in the field of pharmacology. It delves into the milestones in US food and drug law history, the Nuremberg code, the Declaration of Helsinki, and the Belmont report. The presentation also includes discussions on drug discovery paradigms, the role of serendipity in drug discovery, and the phases of clinical development. Furthermore, it explores the ethical guidelines for biomedical research with human subjects and the principles of bioethics. The lecture concludes with insights into the evaluation of clinical studies, the importance of informed consent, and the protection of human subjects in research.