Risk Management Principles for Devices and Pharmaceuticals
95
22. Tibbitts J, et al. Practical approaches to dose selection
for first-in-human clinical trials with novel biopharma-
ceuticals. Regul Toxicol Pharmacol, 2010 58:243-51.
23. Milton MN, Horvath CJ. The EMEA guideline on
first-in-human clinical trials and its impact on pharma-
ceutical development. Toxicol Pathol. 2009 37:363-71.
24. Olejniczak K, et al. Preclinical testing strategies. Drug
Inform J 2001 35:321-36.
95
22. Tibbitts J, et al. Practical approaches to dose selection
for first-in-human clinical trials with novel biopharma-
ceuticals. Regul Toxicol Pharmacol, 2010 58:243-51.
23. Milton MN, Horvath CJ. The EMEA guideline on
first-in-human clinical trials and its impact on pharma-
ceutical development. Toxicol Pathol. 2009 37:363-71.
24. Olejniczak K, et al. Preclinical testing strategies. Drug
Inform J 2001 35:321-36.