Regulatory guidelines for conducting toxicity

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Course Title: Regulatory guidelines for conducting
toxicity studies OECD, ICH, EPA and Schedule Y
Course code: MPL202T
Course Leader: Dr. J. Anbu

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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

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Contents
• Regulatory guidelines for conducting toxicity studies OECD,
ICH, EPA and Schedule Y

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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