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M.Pharm Pharmacology Syllabus

Pharmacology is the M.Pharm specialisation on drug action, screening methods and clinical research. This page gives the complete syllabus of the branch as prescribed by the Pharmacy Council of India, subject by subject and unit by unit.

Source: Pharmacy Council of India (PCI), The Revised Regulations for the Master of Pharmacy Degree Program, Credit Based Semester System, and the M.Pharm syllabus prescribed by the Pharmacy Council of India. The syllabus below is reproduced from the PCI syllabus, unit by unit.

Semester 1

MPL101T Modern Pharmaceutical Analytical Techniques

Subject notes: MPL101T Modern Pharmaceutical Analytical Techniques notes

Unit 1: Spectroscopy I

Unit 2: NMR spectroscopy

Quantum numbers and their role in NMR, principle, instrumentation, solvent requirement in NMR, relaxation process, NMR signals in various compounds, chemical shift, factors influencing chemical shift, spin-spin coupling, coupling constant, nuclear magnetic double resonance, brief outline of principles of FT-NMR and 13C NMR, applications of NMR spectroscopy.

Unit 3: Mass spectroscopy

Principle, theory, instrumentation of mass spectroscopy, different types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI, analyzers of quadrupole and time of flight, mass fragmentation and its rules, metastable ions, isotopic peaks, applications of mass spectroscopy.

Unit 4: Chromatography

Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution, isolation of drug from excipients, data interpretation and applications of: thin layer chromatography, high performance thin layer chromatography, ion exchange chromatography, column chromatography, gas chromatography, high performance liquid chromatography, ultra high performance liquid chromatography, affinity chromatography, gel chromatography.

Unit 5: Electrophoresis and X-ray crystallography

Electrophoresis: principle, instrumentation, working conditions, factors affecting separation and applications of paper electrophoresis, gel electrophoresis, capillary electrophoresis, zone electrophoresis, moving boundary electrophoresis, isoelectric focusing. X-ray crystallography: production of X rays, different X ray diffraction methods, Bragg law, rotating crystal technique, X ray powder technique, types of crystals, applications of X ray diffraction.

Unit 6: Potentiometry and thermal techniques

Potentiometry: principle, working, ion selective electrodes, applications. Thermal techniques: principle, thermal transitions and instrumentation (heat flux and power compensation designs), modulated DSC, hyper DSC, experimental parameters (sample preparation, experimental conditions, calibration, heating and cooling rates, resolution, source of errors) and their influence, advantages and disadvantages, pharmaceutical applications. Differential thermal analysis (DTA): principle, instrumentation, advantages and disadvantages, pharmaceutical applications, derivative differential thermal analysis (DDTA). TGA: principle, instrumentation, factors affecting results, advantages and disadvantages, pharmaceutical applications.

MPL102T Advanced Pharmacology-I

Subject notes: MPL102T Advanced Pharmacology-I notes

Unit 1: General Pharmacology

a. Pharmacokinetics: the dynamics of drug absorption, distribution, biotransformation and elimination. Concepts of linear and non-linear compartment models. Significance of protein binding. b. Pharmacodynamics: mechanism of drug action and the relationship between drug concentration and effect. Receptors, structural and functional families of receptors, quantitation of drug receptor interaction and elicited effects.

Unit 2: Neurotransmission

a. General aspects and steps involved in neurotransmission. b. Neurohumoral transmission in the autonomic nervous system (detailed study of the neurotransmitters adrenaline and acetylcholine). c. Neurohumoral transmission in the central nervous system (detailed study of the neurotransmitters histamine, serotonin, dopamine, GABA, glutamate and glycine). d. Non adrenergic non cholinergic transmission (NANC). Cotransmission. Systemic pharmacology: a detailed study of the pathophysiology of diseases, mechanism of action, pharmacology and toxicology of existing as well as novel drugs used in the following systems. Autonomic pharmacology: parasympathomimetics and lytics, sympathomimetics and lytics, agents affecting the neuromuscular junction.

Unit 3: Central Nervous System Pharmacology

General and local anesthetics. Sedatives and hypnotics, drugs used to treat anxiety. Depression, psychosis, mania, epilepsy, neurodegenerative diseases. Narcotic and non-narcotic analgesics.

Unit 4: Cardiovascular Pharmacology

Diuretics, antihypertensives, antiischemics, antiarrhythmics, drugs for heart failure and hyperlipidemia. Hematinics, coagulants, anticoagulants, fibrinolytics and antiplatelet drugs.

Unit 5: Autocoid Pharmacology

The physiological and pathological role of histamine, serotonin, kinins, prostaglandins and opioid autocoids. Pharmacology of antihistamines, 5-HT antagonists.

MPL103T Pharmacological and Toxicological Screening Methods-I

Subject notes: MPL103T Pharmacological and Toxicological Screening Methods-I notes

Unit 1: Laboratory Animals

Laboratory animals: common laboratory animals, description, handling and applications of different species and strains of animals. Transgenic animals: production, maintenance and applications. Anaesthesia and euthanasia of experimental animals. Maintenance and breeding of laboratory animals. CPCSEA guidelines to conduct experiments on animals. Good laboratory practice. Bioassay: principle, scope and limitations and methods.

Unit 2: Preclinical Screening: General Principles, CNS and Autonomic Pharmacology

Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. General principles of preclinical screening. CNS pharmacology: behavioral and muscle coordination, CNS stimulants and depressants, anxiolytics, anti-psychotics, anti epileptics and nootropics. Drugs for neurodegenerative diseases like Parkinsonism, Alzheimer's and multiple sclerosis. Drugs acting on autonomic nervous system.

Unit 3: Preclinical Screening: Respiratory, Reproductive, Analgesic and Gastrointestinal Pharmacology

Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. Respiratory pharmacology: anti asthmatics, drugs for COPD and anti allergics. Reproductive pharmacology: aphrodisiacs and anti fertility agents. Analgesics, anti inflammatory and antipyretic agents. Gastrointestinal drugs: anti ulcer, anti emetic, anti diarrheal and laxatives.

Unit 4: Preclinical Screening: Cardiovascular, Metabolic, Anticancer and Hepatoprotective Pharmacology

Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. Cardiovascular pharmacology: antihypertensives, antiarrhythmics, antianginal, antiatherosclerotic agents and diuretics. Drugs for metabolic disorders like anti-diabetic, antidyslipidemic agents. Anti cancer agents. Hepatoprotective screening methods.

Unit 5: Preclinical Screening: Immunomodulators, Immunoassay, Alternatives and Extrapolation

Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. Immunomodulators, immunosuppressants and immunostimulants. General principles of immunoassay: theoretical basis and optimization of immunoassay, heterogeneous and homogenous immunoassay systems. Immunoassay methods evaluation; protocol outline, objectives and preparation. Immunoassay for digoxin and insulin. Limitations of animal experimentation and alternate animal experiments. Extrapolation of in vitro data to preclinical and preclinical to humans.

MPL104T Cellular and Molecular Pharmacology

Subject notes: MPL104T Cellular and Molecular Pharmacology notes

Unit 1: Cell Biology

Structure and functions of cell and its organelles. Genome organization. Gene expression and its regulation, importance of siRNA and micro RNA, gene mapping and gene sequencing. Cell cycle and its regulation. Cell death: events, regulators, intrinsic and extrinsic pathways of apoptosis. Necrosis and autophagy.

Unit 2: Cell Signaling

Intercellular and intracellular signaling pathways. Classification of receptor family and molecular structure: ligand gated ion channels, G protein coupled receptors, tyrosine kinase receptors and nuclear receptors. Secondary messengers: cyclic AMP, cyclic GMP, calcium ion, inositol 1,4,5-trisphosphate (IP3), NO and diacylglycerol. Detailed study of the following intracellular signaling pathways: cyclic AMP signaling pathway, mitogen activated protein kinase (MAPK) signaling, Janus kinase (JAK)/signal transducer and activator of transcription (STAT) signaling pathway.

Unit 3: Principles and Applications of Genomic and Proteomic Tools

DNA electrophoresis, PCR (reverse transcription and real time), gene sequencing, micro array technique, SDS page, ELISA and western blotting. Recombinant DNA technology and gene therapy. Basic principles of recombinant DNA technology: restriction enzymes, various types of vectors. Applications of recombinant DNA technology. Gene therapy: various types of gene transfer techniques, clinical applications and recent advances in gene therapy.

Unit 4: Pharmacogenomics

Gene mapping and cloning of disease gene. Genetic variation and its role in health/pharmacology. Polymorphisms affecting drug metabolism. Genetic variation in drug transporters. Genetic variation in G protein coupled receptors. Applications of proteomics science: genomics, proteomics, metabolomics, functionomics, nutrigenomics. Immunotherapeutics: types of immunotherapeutics, humanisation antibody therapy, immunotherapeutics in clinical practice.

Unit 5: Cell Culture Techniques and Biosimilars

a. Cell culture techniques: basic equipments used in cell culture lab. Cell culture media, various types of cell culture, general procedure for cell cultures; isolation of cells, subculture, cryopreservation, characterization of cells and their application. Principles and applications of cell viability assays, glucose uptake assay, calcium influx assays. Principles and applications of flow cytometry. b. Biosimilars.

Practicals and Seminar

Semester 2

MPL201T Advanced Pharmacology-II

Subject notes: MPL201T Advanced Pharmacology-II notes

Unit 1: Endocrine Pharmacology

Molecular and cellular mechanism of action of hormones such as growth hormone, prolactin, thyroid, insulin and sex hormones. Antithyroid drugs, oral hypoglycemic agents, oral contraceptives, corticosteroids. Drugs affecting calcium regulation.

Unit 2: Chemotherapy

Cellular and molecular mechanism of actions and resistance of antimicrobial agents such as beta-lactams, aminoglycosides, quinolones, macrolide antibiotics. Antifungal, antiviral, and anti-TB drugs.

Unit 3: Chemotherapy (continued) and Immunopharmacology

Drugs used in protozoal infections. Drugs used in the treatment of helminthiasis. Chemotherapy of cancer. Immunopharmacology: cellular and biochemical mediators of inflammation and immune response. Allergic or hypersensitivity reactions. Pharmacotherapy of asthma and COPD. Immunosuppressants and immunostimulants.

Unit 4: GIT Pharmacology and Chronopharmacology

GIT pharmacology: antiulcer drugs, prokinetics, antiemetics, antidiarrheals and drugs for constipation and irritable bowel syndrome. Chronopharmacology: biological and circadian rhythms, applications of chronotherapy in various diseases like cardiovascular disease, diabetes, asthma and peptic ulcer.

Unit 5: Free Radicals Pharmacology and Recent Advances

Free radicals pharmacology: generation of free radicals, role of free radicals in etiopathology of various diseases such as diabetes, neurodegenerative diseases and cancer. Protective activity of certain important antioxidants. Recent advances in treatment: Alzheimer's disease, Parkinson's disease, cancer, diabetes mellitus.

MPL202T Pharmacological and Toxicological Screening Methods-II

Subject notes: MPL202T Pharmacological and Toxicological Screening Methods-II notes

Unit 1: Foundations of Toxicology, Regulatory Guidelines and GLP

Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive). Regulatory guidelines for conducting toxicity studies: OECD, ICH, EPA and Schedule Y. OECD principles of Good Laboratory Practice (GLP). History, concept and its importance in drug development.

Unit 2: General Toxicity Studies and Test Item Characterization

Acute, sub-acute and chronic oral, dermal and inhalational studies as per OECD guidelines. Acute eye irritation, skin sensitization, dermal irritation and dermal toxicity studies. Test item characterization: importance and methods in regulatory toxicology studies.

Unit 3: Reproductive Toxicology, Genotoxicity and Carcinogenicity

Reproductive toxicology studies, male reproductive toxicity studies, female reproductive studies (segment I and segment III), teratogenicity studies (segment II). Genotoxicity studies (Ames test, in vitro and in vivo micronucleus and chromosomal aberrations studies). In vivo carcinogenicity studies.

Unit 4: IND Enabling Studies and Safety Pharmacology

IND enabling studies (IND studies): definition of IND, importance of IND, industry perspective, list of studies needed for IND submission. Safety pharmacology studies: origin, concepts and importance of safety pharmacology. Tier 1: CVS, CNS and respiratory safety pharmacology, hERG assay. Tier 2: GI, renal and other studies.

Unit 5: Toxicokinetics and Alternative Methods

Toxicokinetics: toxicokinetic evaluation in preclinical studies, saturation kinetics. Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity testing.

MPL203T Principles of Drug Discovery

Subject notes: MPL203T Principles of Drug Discovery notes

Unit 1: An Overview of the Modern Drug Discovery Process and Target Discovery

An overview of modern drug discovery process: target identification, target validation, lead identification and lead optimization. Economics of drug discovery. Target discovery and validation: role of genomics, proteomics and bioinformatics. Role of nucleic acid microarrays, protein microarrays, antisense technologies, siRNAs, antisense oligonucleotides, zinc finger proteins. Role of transgenic animals in target validation.

Unit 2: Lead Identification and Protein Structure

Lead identification: combinatorial chemistry and high throughput screening, in silico lead discovery techniques, assay development for hit identification. Protein structure, levels of protein structure, domains, motifs and folds in protein structure. Computational prediction of protein structure: threading and homology modeling methods. Application of NMR and X-ray crystallography in protein structure prediction.

Unit 3: Rational Drug Design and Virtual Screening

Rational drug design: traditional vs rational drug design, methods followed in traditional drug design, high throughput screening, concepts of rational drug design, rational drug design methods: structure and pharmacophore based approaches. Virtual screening techniques: drug likeness screening, concept of pharmacophore mapping and pharmacophore based screening.

Unit 4: Molecular Docking, De Novo Design and QSAR Foundations

Molecular docking: rigid docking, flexible docking, manual docking; docking based screening. De novo drug design. Quantitative analysis of structure activity relationship: history and development of QSAR, SAR versus QSAR, physicochemical parameters, Hansch analysis, Free Wilson analysis and relationship between them.

Unit 5: QSAR Statistics, 3D QSAR and Prodrug Design

QSAR statistical methods: regression analysis, partial least square analysis (PLS) and other multivariate statistical methods. 3D QSAR approaches like CoMFA and CoMSIA. Prodrug design: basic concept, prodrugs to improve patient acceptability, drug solubility, drug absorption and distribution, site specific drug delivery and sustained drug action. Rationale of prodrug design and practical consideration of prodrug design.

MPL204T Clinical Research and Pharmacovigilance

Subject notes: MPL204T Clinical Research and Pharmacovigilance notes

Unit 1: Regulatory Perspectives of Clinical Trials

Origin and principles of International Conference on Harmonization, Good Clinical Practice (ICH-GCP) guidelines. Ethical Committee: Institutional Review Board. Ethical guidelines for biomedical research and human participants: Schedule Y, ICMR. Informed consent process: structure and content of an informed consent process; ethical principles governing informed consent process.

Unit 2: Clinical Trials: Types and Design

Experimental study: RCT and non RCT. Observation study: cohort, case control, cross sectional. Clinical trial study team: roles and responsibilities of clinical trial personnel: investigator, study coordinator, sponsor, contract research organization and its management.

Unit 3: Clinical Trial Documentation, Monitoring and Adverse Drug Reactions

Guidelines to the preparation of documents; preparation of protocol, investigator brochure, case report forms, clinical study report. Clinical trial monitoring; safety monitoring in CT. Adverse drug reactions: definition and types; detection and reporting methods; severity and seriousness assessment; predictability and preventability assessment; management of adverse drug reactions; terminologies of ADR.

Unit 4: Basic Aspects, Terminologies and Establishment of Pharmacovigilance

History and progress of pharmacovigilance; significance of safety monitoring; pharmacovigilance in India and international aspects; WHO international drug monitoring programme; WHO and regulatory terminologies of ADR; evaluation of medication safety; establishing pharmacovigilance centres in hospitals, industry and national programmes related to pharmacovigilance; roles and responsibilities in pharmacovigilance.

Unit 5: Methods, ADR Reporting and Tools Used in Pharmacovigilance

International classification of diseases; international nonproprietary names for drugs; passive and active surveillance; comparative observational studies; targeted clinical investigations and vaccine safety surveillance. Spontaneous reporting system and reporting to regulatory authorities; guidelines for ADRs reporting. Argus, Aris G pharmacovigilance, VigiFlow; statistical methods for evaluating medication safety data.

Unit 6: Pharmacoepidemiology, Pharmacoeconomics and Safety Pharmacology

Pharmacoepidemiology, pharmacoeconomics, safety pharmacology.

Practicals and Seminar

Semester 3 and 4

Semester 3 and Semester 4 are common to all M.Pharm specialisations. They cover Research Methodology and Biostatistics (MRM301T), journal club, discussion and presentation, and research work. The full common structure is given on the M.Pharm Common Semester 3 and 4 Syllabus page.