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Table 1 Steps in Drug Development

From: Drug development in pediatric psychiatry: current status, future trends

Discovery and Concept Development
   • Target Identification and Validation
   • Assay Development and Screening
   • Lead Molecule Discovery
   • Lead Molecule Optimization
   • Pharmacodynamics and Toxicology
Proof of Concept/IND
   • Clinical Phase I: PK/PD, ADME, abuse liability
   • Phase II Proof of Concept
Product Development
   • Phase III Registration
   • NDA Approval
   • Phase IV Post Marketing