Magid-Haffner

<h1>1. New Drug Entity</h1><ol><li>a. Sources of new drugs</li><ol><li>New original research </li><li>Modification of existing drug chemistry or delivery system </li></ol><li>b. Patent submission</li></ol></ol> <h1>2. Pre-Clinical Testing</h1><ol><li>a. Safety Testing </li><li>b. Toxicology Studies</li></ol> <h1>3. Analytical Method & Formulation Development</h1><ol><li>Assay development for Purity, impurities and degradants</li><li>Small scale batches for process reproducibility</li></ol> <h1>5. Scale-Up</h1><ol><li>Validation</li><ol><li>Assay Method</li><li>Process</li></ol><li>Tech Transfer of Assay Methods</li><li>Stability Studies</li><ol><li>Real Time</li><li>Accelerated</li></ol></ol> <h1>6. NDA Submission</h1><ol><li>Chemistry Manufacturing and Controls (CMC)</li><li>Final NDA Review </li></ol> <h1>7. Pre-Approval Inspection</h1><ol><li>Manufacturing site Inspection</li><li>Reference Laboratories or other Manufacturing Site inspections</li></ol> <h1>8. FDA Approval</h1><ol><li>Commercial Manufacturing</li><li>Distribution</li></ol> <h1>4. Clinical Trial Materials Manufacturing</h1><ol><li>Investigational New Drug Application (IND)</li><li>Institutional Review Board (IRB)</li><li>Multiple Phase Clinical Trials Begin </li> <ol><li>Phase I: small group of patients to collect baseline data </li><li>Phase II: Evaluation of the effectiveness of the drug </li><li>Phase III: Drugs effects on the general population </li></ol></ol>