Syllabus
Unit 1
UNIT I 10 hours
Principles of toxicity studies
Introduction to general toxicology, History of toxicology, Different branches of toxicology (general, mechanistic, regulatory and descriptive toxicology). 1 hour
Toxicants: Exposure, exposure characterization, Routes of exposure: Organism environment interaction, Human health risk assessment, Hazard identification: Risk assessment, Risk prediction and management. 2 hours
Different regulatory guidelines for toxicity studies: Drug Laws, FDA, OECD, ICH, Schedule Y: Design of preclinical toxicity studies, Clinical risk/benefit analysis. 3 hours
Good Laboratory Practices (GLP): Principles of GLP, GLP establishment, Study plans: Study protocols, SOP writing and implementation, Roles of different personnel in GLP, Quality control and Quality Assurance, Multisite management and principal investigator’s responsibility, Test item characterization – importance and methods in regulatory toxicology studies. 4 hours
Unit 2
UNIT II 6 hours
General toxicity studies as per OECD guidelines
Acute, sub-acute and chronic-oral Toxicity studies 4 hours
Local toxicity studies: Acute eye irritation, skin sensitization, dermal irritation & dermal toxicity studies 1 hour
Inhalational toxicity studies: Acute, subacute and chronic toxicity studies 1 hour
Unit 3
UNIT III 10 hours
Special toxicity studies
Reproductive toxicology studies, Male reproductive toxicity studies (Spermatogenesis; Risk assessment in male reproductive toxicity), female reproductive studies (segment I and segment III), teratogenicity studies (segment II) 4 hours
Genotoxicity studies: AmesTest, invitro and invivo Micronucleus and Chromosomal aberrations studies. 3 hours
Carcinogenicity: Principles of carcinogenicity, dose-setting for carcinogenesis bioassay, transplacental carcinogenesis; Cocarcinogenisis/tumor promotion. 3 hours
Unit 4
UNIT IV 8 hours
Safety pharmacology studies : origin, concepts and importance of safety pharmacology 1 hour Tier1-CVS, CNS and respiratory safety pharmacology, HERG assay. 2 hours
Tier2-GI, renal and other studies. 2 hours
IND enabling studies (IND studies): Definition of IND, importance of IND, industry perspective, list of studies needed for IND submission 3 hours
Unit 5
UNIT V- Toxicokinetics 4 hours
Toxicokinetics: animals and dose groups, exposure measurement, determination of metabolites complicating factors in exposure interpretation, analytical methods according to good laboratory practices, regulatory requirements 2 hours
Saturation kinetics, Importance and applications of toxicokinetic studies 2 hours
Unit 6
UNIT VI Alternative methods to animal toxicity testing. 7 hours
Limitations of animal models, 4 R’s concept, importance and
applications of alternative models 2 hours
3D cell culture and lower animal models 3 hours
Organ-on-chip, examples, challenges and future potential. 2 hours
Unit 7
UNIT VI Alternative methods to animal toxicity testing. 7 hours
Limitations of animal models, 4 R’s concept, importance and
applications of alternative models 2 hours
3D cell culture and lower animal models 3 hours
Organ-on-chip, examples, challenges and future potential. 2 hours
Scope
This subject imparts knowledge on the preclinical safety and toxicological evaluation of drugs & new chemical entities. Different types of toxicology and various guidelines for toxicological studies are included here. The subject provides knowledge on various acute subacute and chronic toxicity studies, various special toxicity studies like reproductive toxicity studies, genotoxicity studies and carcinogenicity studies as well as various local toxicity studies to be performed for various new drugs and chemical entities. It also covers IND enabling studies as well as the concepts and methodology for safety pharmacology studies. This knowledge will make the student competent in regulatory toxicological evaluation.
The subject also imparts knowledge on toxicokinetics and its applications. Guidelines for toxicokinetic studies and its importance in further drug development stages are also covered here. Details and the importance of alternative methods for animal toxicity studies and new developments in toxicological evaluations are also included.
Objectives and Outcomes
Upon successful completion of the course, the students shall be able to,
Knowledge
- K1: Explain the roles of various regulatory authorities in toxicity
- K2: Explore different types of toxicity studies and their
- K3: Recognize the ethical and regulatory requirements in toxicity
- K4: Predict alternative methods in toxicity
- K5: Appraise the principles of toxicokinetics and their application in
- K6: Recommend regulatory requirements in drug development
SKILL
- S1: Apply regulatory guidelines in conducting toxicity
- S2: Perform various toxicity tests according to the recommended
- S3: Execute safety pharmacological studies based on recommended
- S4: Implement good laboratory practices (GLP) in toxicity
- S5: Design IND enabling studies for novel
- S6: Predict the drug behavior in biological systems based on toxicokinetic studies
ATTITUDE
- A1: Value ethical principles in the conduct of scientific
- A2: Work effectively in collaborative research
- A3: Stay updated about current regulations and guidelines in
- A4: Communicate scientific findings clearly and
- A5: Show responsibility in managing laboratory resources and
- A6: Engage in continual learning to improve personal and professional
