Animal studies, preclinical drug testing

To determine whether human testing for a new drug or new drug product is reasonable, it is first necessary to conduct preclinical studies and to submit the IND. The necessary information needed to prepare the IND is outlined in Table 1. The IND is to contain information on appropriate prior animal studies for safety evaluation, any available clinical data, adequate drug identification and manufacturing instructions, and a detailed outline of the proposed clinical study, routs of administration, approximate number of patients to be used, and an estimate of the length of treatment and an environmental impact statement. 

Preclinical drug development also involves animal testing [61]. Data from one rodent species and one nonrodent species are usually collected to determine the absorption, metabolism, and toxicity characteristics of the compound. Both short-term (2 weeks to 3 months) and long-term (up to several years) studies are done. The long-term studies are particularly useful for... 

The development of a new drug involves extensive preclinical (animal) and clinical (human) studies.19,21 The basic procedure for testing a new drug is outlined here and is summarized in Table 1-2. Details about the phases of drug testing can also be found on the FDA website (http //www.fda.gov/cder/handbook). 

Animal pharmacology and toxicology studies—preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use). 

Drug discovery requires a host of inputs, new ideas, design and synthesis of substances, evaluation of preclinical toxicity tests in animals, clinical studies in human volunteers, permission to market the drug, postmarketing studies of safety, and comparison with other medicines. Drug development is highly technical and enormously expensive, with a success rate of 1 in 10,000 compounds. 

Preclinical studies Studies that test a drug on animals and other nonhuman test systems. They must comply with the FDA s good laboratory practices. Data about a drug s activities and effects in animals help to establish boundaries for... 

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