MPL 202T_05_Regulatory guidelines for conducting toxicity studies.pdf
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This lecture discusses regulatory guidelines for conducting toxicity studies according to organizations like OECD, ICH, EPA and Schedule Y. It describes the general regulatory system in India, the functions of CDSCO, Schedule Y drugs, Good Clinical Practice, and the basic requirements for clinical trial registration.
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- 1. ©M. S. Ramaiah University of Applied Sciences 1 Course Title: Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y Course code: MPL202T Course Leader: Dr. J. Anbu
- 2. ©M. S. Ramaiah University of Applied Sciences 2 Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y Lecture No: 05 By the end of this Lecture, students will be able to: Describe the general regulatory system in India Discuss the functions of CDSCO Describe the schedule Y drugs Explain the Good Clinical Practice Enlist the basic requirements for clinical trial registration
- 3. ©M. S. Ramaiah University of Applied Sciences 3 Contents • Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y
- 4. ©M. S. Ramaiah University of Applied Sciences 4
- 5. ©M. S. Ramaiah University of Applied Sciences 5
- 6. ©M. S. Ramaiah University of Applied Sciences 6
- 7. ©M. S. Ramaiah University of Applied Sciences 7
- 8. ©M. S. Ramaiah University of Applied Sciences 8
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- 30. ©M. S. Ramaiah University of Applied Sciences 30 Summary This lecture highlighted the • General regulatory system in India • Functions of CDSCO • Schedule Y drugs • Good Clinical Practice • Basic requirements for clinical trial registration