신약개발 과정

Development

• Clinical Need Assessment
• Target ID & Validation -> Define TPP
• Screening -> Hit 도출
• Optimization  -> Lead 도출 [MedChem, Secondary Assays]
• Non-GLP Studies -> [Animal Efficacy, Formulation, Safety & Tox]
• FDA Pre-IND meeting

 

Regulatory

• Preclinical GLP [Safety/Efficacy, Manufacturing, Formulation, Stability]
• Define Drug Product or Drug Substance
• Clinical Trial Design - Get IRB approval, File IND with FDA
• Phase 1 (first in human)
• Phase 2 (dose efficacy) - Later preclinical safety testing [reproductive tox, carcinogenicity]
• Phase 3 (validation)