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Medicines (Safety Tests)

Volume 222: debated on Thursday 2 April 1992

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To ask the Secretary of State for Health which safety tests for potential new medicines are carried out on human cells in vitro rather than on animals.

One type of safety testing that is appropriate for most new medicines involves assaying for mutagenic potential. The purpose of the test is to discover whether a substance may cause change in the genetic material which could be inherited by future generations of cells or individuals.Three of the routine screening assays are performed in vitro with bacteria or mammalian, including human, cells as the target system. Specifically, human lymphocytes are used to ascertain whether the test substance is capable of producing chromosome breakage or other aberrations such as deletion of sections of chromosome. In second line testing, when confirmation of routine assay effects is required, procedures for measuring chromosome exchange and unscheduled DNA synthesis are employed. These may also use human cell lines in vitro to achieve their objective.The safety of, for example, monoclonal antibody carriers of toxic cancer therapy agents can be tested by determining specificity of tissue affinity, using human material in vitro.