Regulatory Toxicology Pharma 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective III) detail syllabus for Pharmacy (Pharma), 2017 regulation is collected from the Anna Univ official website and presented for students of Anna University. The details of the course are: course code (PY8007), Category (PE), Contact Periods/week (3), Teaching hours/week (3), Practical Hours/week (0). The total course credits are given in combined syllabus.
For all other pharma 6th sem syllabus for b.tech 2017 regulation anna univ you can visit Pharma 6th Sem syllabus for B.Tech 2017 regulation Anna Univ Subjects. For all other Professional Elective III subjects do refer to Professional Elective III. The detail syllabus for regulatory toxicology is as follows.
Course Objective:
- The objective of the course is to provide up-to-date information of the international, and national regulatory processes concerning chemical risk assessment in humans, biomaterials and medical devices.
- Also to develop awareness of how toxicology is applied in real world regulatory situations and to develop knowledge of the complexities and competing interests that are part of the regulatory decision making
- Overview of the methods used to evaluate risk and produce safety guidelines, including laboratory testing, epidemiological studies and evaluation of the literature and of the online resources available to gather this information.
Unit I
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Unit II
Regulations Governing Toxicology
Aim and mission, working areas, regulatory process in toxicology, quality assurance in regulatory toxicology, toxicological risk assessment.
Unit III
Toxicology and Drug Product Regulations
Introduction, aspects of the IND / NDA process, toxicology and other issues, paediatric drug products, drug combinations, excipients and reformulations, conclusions.
Unit IV
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Unit V
Alternatives in Toxicology
Introduction, Societal need for information about toxic chemicals, evolution of alternatives in toxicology, humane science and animal welfare, assessing alternatives, challenges and future.
Course Outcome:
The student can be able to
- Describe the general principles in toxicological risk assessment, both ecotoxicology and human toxicology, legal regulations and alternative options in toxicology.
- Understand the basic principles of and have current, cutting-edge knowledge in environmental and human health toxicology.
- Demonstrate an understanding of legal, regulatory, and ethical considerations relating to toxicology within the broader societal context
Text Books:
- Shayne C. Gad, Regulatory Toxicology, Second Edition,, CRC Press, 2001.
- Regulatory Toxicology in the European Union, Ian Dewhurst, Royal Society of Chemistry, 2017
- Regulatory Toxicology: Essentially Practical Aspects, Renuka Sengupta, Narosa Publishing House,2015
References:
- Shayne C. Gad. Taylor and Francis, Regulatory Toxicology, 2nd Edition, CRC Press,2001.
- Toxicology and Regulatory Process. Sidney Green, CRC Press, 2006.
- Regulatory Toxicology. Eds. Franz Xaver Reichl and Michael Schwenk. Springer, 2014.
For detail syllabus of all other subjects of B.Tech Pharma, 2017 regulation do visit Pharma 6th Sem syllabus for 2017 Regulation.
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