PY8007 - REGULATORY TOXICOLOGY (Syllabus) 2017-regulation Anna University

PY8007 - REGULATORY TOXICOLOGY (Syllabus) 2017-regulation Anna University

PY8007	REGULATORY TOXICOLOGY	LPTC

3003

OBJECTIVES:

• 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	INTRODUCTION	8

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	8

Aim and mission, working areas, regulatory process in toxicology, quality assurance in regulatory toxicology, toxicological risk assessment.

UNIT III	TOXICOLOGY AND DRUG PRODUCT REGULATIONS	8

Introduction, aspects of the IND / NDA process, toxicology and other issues, paediatric drug products, drug combinations, excipients and reformulations, conclusions.

UNIT IV	TOXICOGENEOMICS, GENETIC TOXICOLOGY AND REGLATORY POLICY	12

Microarrays in toxicology, proteomics and metabolomics, case examples, toxicogenomics in regulatory environment. Initiation of genetic toxicology testing, EPA GENE TOX (Phase I and II), 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.

TOTAL : 45 PERIODS

OUTCOMES: 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:

1. Shayne C. Gad, Regulatory Toxicology, Second Edition,, CRC Press, 2001.
2. Regulatory Toxicology in the European Union, Ian Dewhurst, Royal Society of Chemistry, 2017
3. Regulatory Toxicology: Essentially Practical Aspects, Renuka Sengupta, Narosa Publishing House,2015

REFERENCES:

1. Shayne C. Gad. Taylor and Francis, Regulatory Toxicology, 2nd Edition, CRC Press,2001.
2. Toxicology and Regulatory Process. Sidney Green, CRC Press, 2006.
3. Regulatory Toxicology. Eds. Franz Xaver Reichl and Michael Schwenk. Springer, 2014.