1. Food, Drug, and Cosmetic Act,1938
2. Presented at the Fourth International Conference on Harmonisation;U.S. Food and Drug Administration and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): efficacy guidelines,1997
3. Food, Drug, and Cosmetic Act. 21 USC §505(d) and 513(a) (1997).
4. General considerations for the clinical evaluation of drugs;U.S. Food and Drug Administration,1997
5. On management and the learning process;Kolb,1973