ABOUT THE COURSE:This 12-week course, Pharmacological and Toxicological Screening Methods, offers a comprehensive exploration of the methodologies and tools vital for assessing the therapeutic potential and safety profiles of new drugs, chemicals, and biological compounds. The program begins with foundational principles of Pharmacological assays, emphasizing toxicity types, dose-response relationships, and safety thresholds. As the course progresses, participants delve into advanced screening techniques, including in vitro assays (e.g., cell-based models, enzyme inhibition studies) and in vivo methods (e.g., animal models for efficacy and toxicity). Additionally, the curriculum incorporates OECD guidelines, ethical considerations in animal research, and alternatives to animal experimentation, providing a well-rounded understanding of preclinical evaluation techniques.INTENDED AUDIENCE: Pharmacy professionals, Pharmacologists, Biologists, BiotechnologistsPREREQUISITES: The participants should have basic knowledge of biology. A keen interest in the domains of biochemistry, physiology, and molecular biology is desirable.INDUSTRY SUPPORT: Pharmaceutical & Biotech industries:Sun Pharma Ltd, Glen Mark Pharmaceuticals, Mylan Laboratories, Bharat Biotech, Dr. Reddy’s Laboratories, Piramal Life Sciences Ltd, Glaxo Smithkiline, Johnson & Johnsson etc

Syllabus

Week 1: Laboratory animals: Ethics of animal research
1. Common laboratory animals and their maintenance
2. Anaesthesia and euthanasia of experimental animals
3. CPCSEA guidelines to experiment on animals
4. OECD Principles for Good Laboratory Practice
5. Morals of animal testing and 3R strategy
Week 2:Pharmacological screening methods
1. Pharmacological screening and its types
2. Methods to determine the pharmacological profile of the drug,
3. Inflammation, apoptosis, necrosis
4. Classification of Bioassay and their limitations
5. Immunological assay
6. Humanized Mouse and its applications
Week 3:Toxicological Screening
1. Introduction to toxicology
2. Toxicity testing studies as per OECD guidelines
3. Acute oral toxicity (UP-and-Down-Procedure)
4. Limit test and main test
5. History and its importance in drug development
Week 4:Genotoxicity study
1. Genotoxicity
2. Ames test
3. In vitro in vivo studies
4. micronucleus test
5. Chromosomal aberrations and its analysis
Week 5:Principles of Toxicity Evaluations
1. Acute,
2. sub-acute toxicity study
3. Chronic toxicity studies
4. Evaluation of ED50,LD50 and TD values
5. ICH guidelines for drug toxicity studies
Week 6:Carcinogenicity studies
1. Carcinogen and mechanism of carcinogenesis
2. Classification of carcinogens based on MOA
3. Hallmarks of cancer
4. History of chemical carcinogenesis
5. Categories of Carcinogenicity studies
Week 7:Alternatives to animal experimentation
1. Need for animal alternatives
2. High throughput Screening (HTS)Assays (Biochemical & cell-based assays)
3. In vitro models, Skin patch test, stem cell test
4. Insilco models, Microfluidic chips, recent trend
Week 8:Screening Models for Parkinson’s Disease
1. Introduction of Parkinson's disease
2. Clinical symptoms
3. Pathophysiology
4. Current pharmacotherapeutics
5. Models of Parkinson’s disease (MPTP,6-OHDA, Rotenone, and genetic models)
Week 9:Models for Alzheimer’s disease
1. Introduction of Alzheimer’s disease
2. Symptoms and risk factors
3. Pathophysiology
4. Models of Alzheimer’s disease
5. Data analysis
Week 10:Screening Models for Anti-depressant Activity
1. Depression and its signs
2. Clinical symptoms
3. Theories of depression
4. Pathogenesis
5. Models of depression (Tail suspension test, despair swim test, etc)
Week 11:Screening Models for Anti-diabetic Activity
1. Diabetes and its signs
2. Clinical symptoms
3. Pathophysiology
4. Models of Diabetes
5. Data analysis
Week 12:Quiz: Multiple Choice Questions