Product Development and Technology Transfer

Product Development and Technology Transfer

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1. Principles of Drug Discovery and Development:

• Introduction to Drug Discovery and Development
• Clinical Research Process
• Development and Informational Content for:
• Investigational New Drugs Application (IND)
• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Supplemental New Drug Application (SNDA)
• Scale Up Post Approval Changes (SUPAC) and Bulk Active Chemical Post Approval Changes (BACPAC)
• Post Marketing Surveillance
• Product Registration Guidelines:
• CDSCO (Central Drugs Standard Control Organization)
• USFDA (United States Food and Drug Administration)

2. Pre-formulation Studies:

• Introduction/Concept of Pre-formulation Studies
• Organoleptic Properties, Purity, and Impurity Profiles
• Particle Size, Shape, and Surface Area Analysis
• Solubility and Methods to Improve Drug Solubility:
• Surfactants and Their Importance
• Co-solvency Techniques
• Study of Crystal Properties and Polymorphism
• Pre-formulation Protocol
• Stability Testing during Product Development

3. Pilot Plant Scale Up:

• Concept and Significance of Pilot Plant Scale Up
• Design and Layout of Pilot Plant Scale Up Study
• Operations and Techniques for Large Scale Manufacturing of:
• Solids
• Liquids
• Semisolid Dosage Forms
• Parenteral Dosage Forms
• New Era of Drug Products: Opportunities and Challenges

4. Pharmaceutical Packaging:

• Pharmaceutical Dosage Forms and Their Packaging Requirements
• Pharmaceutical Packaging Materials
• Medical Device Packaging
• Enteral Packaging
• Aseptic Packaging Systems
• Container Closure Systems
• Issues Facing Modern Drug Packaging
• Selection and Evaluation of Pharmaceutical Packaging Materials
• Quality Control Tests for Containers, Closures, and Secondary Packing Materials

5. Technology Transfer:

• Development of Technology by Research & Development (R&D)
• Technology Transfer from R&D to Production
• Optimization and Production Processes
• Qualitative and Quantitative Technology Models
• Documentation in Technology Transfer:
• Development Report
• Technology Transfer Plan
• Exhibit