Pharmd Notes

"Click on Orange colour titles for notes" 1. Drug development process:   Introduction Various Approaches to drug discovery      1. Pharmacological      2. Toxicological      3. IND Application      4. Drug characterization      5. Dosage form   2.   Clinical development of drug :      1.  Introduction to Clinical trials      2.   Various phases of clinical trial .      3.   Methods of post marketing surveillance            4.  Abbreviated New Drug Application submission .      5. Good Clinical Practice                 - ICH  guidelines               - GCP  guidelines               - Central drug standard control organisation (CDSCO) guidelines           6. Challenges in the implementation of guidelines      7. Ethical guidelines in Clinical Research      8. Composition, responsibilities, procedures of IRB / IEC      9. Overview of regulatory environment in                 -  USA                  - Europe