Curriculum
- 7 Sections
- 27 Lessons
- 2 Days
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- Introduction to Drug Evolution Process3
- Investigational New Drug (IND) Applications5
- Biological vs. Chemical Drug Candidates5
- 3.1Overview of biological drugs: Monoclonal antibodies, vaccines, biosimilars.
- 3.2Overview of chemical drugs: Small molecules and synthetic drugs.
- 3.3Comparative discussion: Development timelines, challenges, and approval pathways.
- 3.4Trends in drug evolution: Shift towards biologics.
- 3.5Activity: Breakout session for identifying pros and cons of biologics vs. chemicals in a case scenario.
- Regulatory Pathways and Submission Process3
- New Drug Application (NDA)4
- Abbreviated New Drug Application (ANDA)4
- Lifecycle Management of Drug Approvals3
Stages of drug evolution: Discovery → Preclinical → Clinical → Approval → Post-marketing.
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