Preclinical studies

In order to gain approval for general medical use, the quality, safety and efficacy of any product must be demonstrated. Demonstration of conformance to these requirements, particularly safety and efficacy, is largely attained by undertaking clinical trials. However, preliminary data, especially safety data, must be obtained prior to the drug's administration to human volunteers. Regulatory authority approval to commence clinical trials is based largely upon preclinical pharmacological and toxicological assessment of the potential new drug in animals. Such preclinical studies can take up to 3 years to complete, and at a cost of anywhere between US$10 million and US$30 million. On average, approximately 10 per cent of potential new drugs survive preclinical trials.

In many instances, there is no strict set of rules governing the range of tests that must be undertaken during preclinical studies. However, guidelines are usually provided by regulatory authorities. The range of studies generally undertaken with regard to traditional chemical-based pharmaceuticals is summarized in Table 4.2. Most of these tests are equally applicable to biop-harmaceutical products.

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