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And animal healthy patient patient Process/ Testing
Studies volunteers volunteers volunteers appr0val radttiratl
By FDA
Purpose Assess safety Determine Evaluate Confirm
And biological Safety and Effectiveness, Eflectiveness,
activity dosage Look for side Monitor adverse
Effects Reactions kom
Long-term use
Success rate 5,000 5 enter trials 1 approved
compounds
Timeline 0 Years 6.5 Years 8.0 Years 10.0 Years 13.5 Years 15.0 Years
grJid r rfi,roounr:ii'rr$ncfrarrrrsr'lnilor.r*ioiiuaariGt#rirurirE lilyiaonalo
fillr : Gilbertsom EW, Francesco AS. Clinical development, regutations, and trends for OTC drugs. In : Guarino
AR, editor. New drug approval process. 3'd ed. New York : Marcel Dei<ker; 2000. p. 384
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Phase Number of Patients Lenglh Purpose Percent of drugs
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2 Up to several hundred Several months Some short-term 33 o/o
To 2 years safety, dosage and effectiveness
3 Several hundred to 1 to 4 years Safety, dosage, effectiveness 25-30 oh
several thousand
fir:t : Troetel MW. The investigational new drug application and the investigaor's brochure. In: Guarino
AR, editor. New drug approval process. 3'o ed. New York : Marcel Dekker; 2OOO. p.59
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