New Guidelines to Be Laid While Testing Experimental Drugs

by Medindia Content Team on  July 25, 2006 at 9:16 PM Drug News   - G J E 4
New Guidelines to Be Laid While Testing Experimental Drugs
Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) recommended new and strict guidelines which stated that researchers should proceed with extreme care and caution while testing pioneering drugs.

One such drug trial conducted on March left six volunteers in the state of coma. TGN1412, designed to treat leukemia, autoimmune and inflammatory diseases. The new drug was tested at the Parexel trial facility in Northwick Park Hospital caused organ failure and damaged the immune system of the volunteers.

The victims were given doses of the drug in turn, but by the time doctors realized its effect, all patients had been given the drug. Hence ABPI initiated a report which was mainly to make sure that such incidents do not repeat. A spokesman for the ABPI said that new guidelines are being recommended to the parliament for testing new drugs. German drug maker TeGenero AG, which produced TGN1412, filed for bankruptcy protection earlier this month.


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Very unfortunate; will delay many potentially life saving drugs to come to the market. These drugs in terminal cancers are more toxic than normal bu sometimes are the only way forward.
sunny1 Tuesday, July 25, 2006

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