Regulatory Toxicology detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the Pharma students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Pharmacy 5th Sem scheme and its subjects, do visit Pharma 5th Sem 2021 regulation scheme. For Professional Elective-I scheme and its subjects refer to Pharma Professional Elective-I syllabus scheme. The detailed syllabus of regulatory toxicology is as follows.
Course Objectives:
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Unit I
INTRODUCTION
Regulatory aspects and strategy in medical device and biomaterials safety evaluation. Regulations affecting cosmetic and over-the- counter drug products.
Unit II
REGULATIONS GOVERNING TOXICOLOGY 9
Aim and mission, working areas, regulatory process in toxicology, quality assurance in regulatory toxicology, toxicological risk assessment.
Unit III
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Unit IV
TOXICOGENEOMICS, GENETIC TOXICOLOGY AND REGULATORY POLICY10
Microarrays in toxicology, proteomics and metabolomics, case examples, toxicogenomics in regulatory environment. Initiation of genetic toxicology testing, ICPEMC, NTP, Genetic toxicology technologies and concepts. Influence of genetic toxicology research on regulatory policy, future role in safety testing strategies.
Unit V
ALTERNATIVES IN TOXICOLOGY 9
Introduction, Societal need for information about toxic chemicals, evolution of alternatives in toxicology, humane science and animal welfare, assessing alternatives, challenges and future.
Text Books:
- Regulatory Toxicology. Eds. Franz XaverReichl and Michael Schwenk. Springer, 2014.
- Shayne C. Gad, Regulatory Toxicology, Second Edition,, CRC Press, 2001.
- Toxicology and Regulatory Process. Sidney Green, CRC Press, 2006.
Reference Books:
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Course Outcomes:
The student shall be able to
- Describe the general principles in toxicological risk assessment
- Apprehend both ecotoxicology, human toxicology, and Quality Assurance
- Understand the basic principles of and have current, cutting-edge knowledge in IND/NDA regulatory process.
- Demonstrate an understanding of Toxicogenomics
- Describe the Genetic Toxicology and ethical considerations relating to toxicology within the broader societal context
- Comprehend alternative options in toxicology.
For detailed syllabus of all the other subjects of Pharmacy 5th Sem, visit Pharma 5th Sem subject syllabuses for 2021 regulation.
For all Pharmacy results, visit Anna University Pharma all semester results direct link.