Minimising Risk in First-in-Man Trials
Lancet 2007 May 5-11; 369(9572): 1496-1497
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Risk of tumorigenesis in first-in-human trials of embryonic stem cell neural derivatives: ethics in the face of long-term uncertainty Hess, Pascale H. (2009-05)While the successful differentiation of human embryonic stem cells into high purity populations of specialized cells is viewed as a major step towards the safety of prospective human transplantation trials, concerns about ...
Guidelines on Requirements for First-in-Man Clinical Trials for Potential High-Risk Medicinal Products. Released for Consultation 2007 March 22 Unknown author (European Medicines Agency. Committee for Medicinal Products for Human Use [CHMP], 2007-03-23)