Week 6: clinical trails, role of regulatory authorities, legal and regulatory issues
Chapter 4: Drug development process. Page: 84 to 101
In this week, we studied the
- clinical trails/ human clinical trails
- Phases of clinical trails
- role of regulatory authories specially Food and Drug Administration (FDA)
- Legal and regulatory issues
Course Material
- Week 1: Introduction to Pharmaceutical Biotechnology
- Week 2: Drug development process and properties of effective drug
- Week 3: impact of genomics and other technologies upon drug discovery
- Week 4: Functional Genomics, Pharmacogenomics, routes of drug administration
- Week 5: Lab scale studies, pre clinical studies and drug toxicity
- Week 6: clinical trails, role of regulatory authorities, legal and regulatory issues
- Week 7: Sources of recombinant proteins (drugs)
- Week 8: Upstream processing for production of biopharmaceutical
- Week 9: Recovering the recombinant protein at manufacturing scale
- Week 10: purification of biopharmaceutical
- Week 11: Final product formulations and its processing
- Week 12: Final product analysis: Protein based contaiminants
- Week 13: Final product analysis: Non protein based contaiminants
- Week 14: Analysis of Biopharmaceutical and validation studies
- Week 15: Polymers used in pharmaceutical industory and controlled drug release systems
- Chapters 15
- Department Biotechnology
- Teacher
Mrs. Misbah Hussain
