Читать книгу Demystifying Research for Medical and Healthcare Students - John L. Anderson - Страница 59

Before it was trialled on human subjects, Fialuridine was tested on animals, including mice, rats, dogs, monkeys, and woodchucks. Those tests found that animals could survive doses which were a hundred times more than those given to humans without any toxic reactions. A Phase II trial on human subjects was conducted. In week 13 one of the subjects suddenly developed hepatic toxicity and lactic acidosis. The trial was stopped. But seven more subjects became ill and five died. Two had to have liver transplants. These totally unforeseen consequences led to a review of protocols for testing potent biological molecules on human subjects. Attarwala (2010) concluded, ‘Though there is always a risk involved with clinical trials, these risks can be potentially reduced if more scientific research toward development of animal models closely mimicking drug behavior in humans can be developed.’