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- https://bio.libretexts.org/Bookshelves/Introductory_and_General_Biology/Biology_(Kimball)/20%3A_General_ScienceThis page discusses the need for controlled experiments to establish causation between factors A and B, highlighting the impracticalities in human studies that lead to the use of epidemiological metho...This page discusses the need for controlled experiments to establish causation between factors A and B, highlighting the impracticalities in human studies that lead to the use of epidemiological methods. It emphasizes the importance of validating new drugs and treatments through clinical studies to ensure they improve upon existing methods. Additionally, it outlines the scientific approach, which combines common sense with specific characteristics that define scientific inquiry.
- https://bio.libretexts.org/Bookshelves/Introductory_and_General_Biology/Biology_(Kimball)/20%3A_General_Science/20.02%3A_Types_of_Clinical_StudiesThis page discusses the research methods in medicine for developing new drugs and procedures, highlighting the importance of validating improvements through various study types. It contrasts retrospec...This page discusses the research methods in medicine for developing new drugs and procedures, highlighting the importance of validating improvements through various study types. It contrasts retrospective studies—which may introduce bias—with prospective studies that follow healthy populations. Clinical trials are emphasized as the gold standard due to their randomization and blinding, which help alleviate bias.
- https://bio.libretexts.org/Bookshelves/Introductory_and_General_Biology/Biology_(Kimball)/20%3A_General_Science/20.06%3A_DrugsThis page outlines the drug testing process, which starts with testing numerous chemicals on lab animals and may lead to human trials through an IND application to the FDA. The human trials consist of...This page outlines the drug testing process, which starts with testing numerous chemicals on lab animals and may lead to human trials through an IND application to the FDA. The human trials consist of three phases: Phase I focuses on safety in healthy volunteers, Phase II tests efficacy and side effects in patients, and Phase III collects comprehensive safety and effectiveness data. Upon successful completion, a NDA is submitted, and the drug is branded for market release.
