Lecture

Drug Development and Ethical Principles

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Description

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.

Official source

Ontological neighbourhood

Philosophy

Ethics: Topics in ethics

Related concepts (30)

Clinical trial

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought.

Belmont Report

The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report summarizes ethical principles and guidelines for human subject research.

Drug development

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.

Bioethics

Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine, and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health.

Informed consent

Informed consent is a principle in medical ethics and medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed.

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