The primary role of toxicology in the drug development process is to screen new drug candidates for potentially adverse effects. Promising compounds must demonstrate that their therapeutic advantages outweigh any risks associated with their use. Researchers must determine at what exposure level a compound becomes harmful and whether it is efficacious below that level. This risk-benefit analysis is performed utilizing relevant in vitro technologies as well as in vivo animal models.
Regulatory authorities require all pharmaceutical companies to perform rigorous safety and risk assessments on any compounds considered for use in humans. Copious amounts of data from these tests must be submitted before any
compound passes into the clinical stage. Drug Safety departments, as they are often called, are responsible for carrying out relevant tests and coordinating the collection of this data for regulatory submission. Key areas of study are potential carcinogenicity, genetic toxicity, and systemic exposure.
The law requires that all drug candidates must be tested in animals before they can be used in humans. However, since the use of animals in pharmaceutical research has many ethical considerations and is extremely controversial, most companies prefer to utilize in vitro assays to predict toxic outcomes before a compound is ever used on an animal. These assays allow researchers to eliminate the most harmful compounds very early on. Many promising drug candidates never make it beyond this stage. The use and treatment of laboratory animals is subject to regulation in the United States and around the world. A research center in the U.S. wishing to utilize laboratory animals is required by law to maintain an ethical oversight committee, called an Institutional Animal Care and Use Committee (IACUC), whose purpose is to ensure the proper treatment and welfare of the animals. Committee members perform regular inspections of facilities and must give approval before any experiments can be carried out. An information specialist may be invited to participate on such a committee, and the library is often required to perform literature searches on animal models and alternative testing.
The Food and Drug Aministration (FDA) is very specific as to the types of assays and testing procedures that are required when submitting an investigational new drug (IND) or new drug application (NDA). The agency issues numerous regulatory guidances to help industry comply with these regulations. These documents ensure that researchers collect the appropriate data in the appropriate format for government review. An information specialist supporting this function must provide ready access to these documents and keep track of changes and updates.
There is a considerable amount of overlap among the traditional chemistry/pharmacology resources and those used to support toxicology. Many of the traditional medical and clinical databases cover this area either through actual subsets of data [National Library of Medicine's (NLM's) Tox-line®] or via specialized indexing terms. Drug and chemical references usually provide toxicologic data, and relevant articles are often published in journals devoted to other topics. The resources included on the following list are those that focus primarily on toxicology and closely related topics. Many of these resources are available in electronic format and may be offered through a variety of vendors.
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