Course Program

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#1Introduction to Drug Development
  • History of Drug Development---
  • Stages of Drug Development---
  • Key Stakeholders in Drug Development---
  • Ethics in Research---
#2Drug Discovery and Lead Identification
  • Target Identification---
  • High-throughput Screening---
  • Hit-to-Lead Process---
  • Biochemical Assays---
  • Computational Modeling---
#3Preclinical Studies
  • Animal Models---
  • Organoid Models---
  • Toxicology Studies---
  • Pharmacokinetics and Pharmacodynamics---
  • Formulation Development---
#4Clinical Trials Phase I
  • Objective and Design---
  • Patient Recruitment---
  • Safety and Dosing---
#5Clinical Trials Phase II
  • Efficacy and Side Effects---
  • Patient Demographics---
  • Data Collection Methods---
#6Clinical Trials Phase III
  • Large Scale Testing---
  • Regulatory Aspects---
  • Monitoring and Safety Tests---
  • Publication of Results---
#7Regulatory Approval Processes
  • Understanding FDA and EMA---
  • Submitting New Drug Applications---
  • Response to Feedback---
  • Approval and Labeling---
#8Post-marketing Surveillance
  • Pharmacovigilance---
  • Reporting Systems---
  • Phase IV Clinical Trials---
  • Long-term Safety---
#9Challenges in Drug Development
  • Patent-related Issues---
  • Handling Failures---
  • Cost and Time Factors---
  • Public and Private Partnerships---
#10Emerging Trends
  • Personalized Medicine---
  • Biologics and Biosimilars---
  • Advanced Therapeutics---
  • Digital Health Tools---