Lecture

Preclinical Animal Models: Selection & Rationale

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In course

CH-332: Medicinal chemistry

Sitting at the crossroad of organic chemistry and medicine, this course outlines how an initial hit compound transitions into a lead candidate, and ultimately a drug, in the modern drug discovery world. Note: the course is held only during 2nd half of spr ...

Description

This lecture covers the selection and rationale behind preclinical animal models in drug development, focusing on the 10 to 15-year path to a marketed small-molecule drug. It discusses the timeline of preclinical studies, clinical trials, and FDA approval, emphasizing the importance of the 3Rs principle in animal research. The lecture explores the complexity of species used in preclinical models, the validity scoring systems, and the practical application of different models at various stages of drug discovery. It also delves into the challenges of reproducibility in preclinical research and the need for improved methodologies to predict human toxicities. Case studies involving zebrafish and fruit fly models are presented to illustrate the potential of these models in drug discovery.

Instructor

Yimon Aye

Official source

Ontological neighbourhood

Health sciences

Pharmacology: Pharmacokinetics

Related concepts (32)

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.

Food and Drug Administration

The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

New Drug Application

The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug.

Approved drug

An approved drug is a medicinal preparation that has been validated for a therapeutic use by a ruling authority of a government. This process is usually specific by country, unless specified otherwise. In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition.

Invasive species

An invasive or alien species is an introduced species to an environment that becomes overpopulated and harms its new environment. Invasive species adversely affect habitats and bioregions, causing ecological, environmental, and/or economic damage. The term can also be used for native species that become harmful to their native environment after human alterations to its food web - for example, the purple sea urchin (Strongylocentrotus purpuratus) which has decimated kelp forests along the northern California coast due to overharvesting of its natural predator, the California sea otter (Enhydra lutris).

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