drug development process ppt
Drug Development Process
Presentation · PPTX
| # | Slide |
|---|---|
| 1 | Title slide |
| 2 | Lecture overview / agenda |
| 3 | Introduction — historical perspective & why it's complex |
| 4 | Visual timeline — all phases with durations on a dark infographic |
| 5 | Step 1: Drug Discovery — target ID & HTS |
| 6 | Step 2: Lead Optimization & ADME profiling |
| 7 | Step 3: Preclinical Studies — in vitro & in vivo |
| 8 | Step 4: IND Application & IRB / GCP |
| 9 | Phase I — Safety & tolerance (badge design) |
| 10 | Phase II — Efficacy & dose finding |
| 11 | Phase III — Large-scale RCTs |
| 12 | NDA/BLA Submission & FDA review pathways (Breakthrough, Fast Track, Accelerated) |
| 13 | Phase IV — Post-marketing surveillance & pharmacovigilance |
| 14 | Key regulatory & PK/PD concepts (two-column reference slide) |
| 15 | Challenges & future: AI, pharmacogenomics, adaptive trials |
| 16 | Drug attrition statistics — the real numbers |
| 17 | Summary & sources |
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