References
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- Department of Health and Human Servicesi Food and Drug Administration. New drugs for investigational use 1987; 312: 64–96, 21 CFR §
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- Department of Health and Human Services. Food and Drug Administration: Obligations of clinical investigators of regulated articles; proposed regulations. Fed Regist 1978; 43(153)35210–29
- Food and Drug Administration. Clinical testing for safe and effective drugs. Food and Drug Administration, Rockville, MD, 74–3015, DHEW publication no. (FDA)