Study of the development of the following classes of drugs, Classification, mechanism of action, uses of drugs mentioned in the course, Structure activity relationship of selective class of drugs as specified in the course and synthesis of drugs superscripted by (*)
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products of the following classes :
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products of the following classes: Macrolide: Erythromycin Clarithromycin, Azithromycin.
Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.
Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir, Ritonavir.
Historical development, chemistry, classification and SAR of Sulfonamides: Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*, Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mefenide acetate, Sulfasalazine.
Various approaches used in drug design.
Physicochemical parameters used in quantitative structure activity relationship (QSAR) such as partition coefficient, Hammet’s electronic parameter, Tafts steric parameter and Hansch analysis. Pharmacophore modeling and docking techniques.
Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry. Foye’s Principles of Medicinal Chemistry.
Burger’s Medicinal Chemistry, Vol I to IV.
Introduction to principles of drug design- Smith and Williams. Remington’s Pharmaceutical Sciences.
Martindale’s extra pharmacopoeia. Organic Chemistry by I.L. Finar, Vol. II.
The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
Indian Pharmacopoeia.
Text book of practical organic chemistry- A.I.Vogel.
Sulphanilamide
7-Hydroxy, 4-methyl coumarin Chlorobutanol
Triphenyl imidazole Tolbutamide Hexamine
Dapsone Chlorpheniramine maleate Benzyl penicillin
Preparation of medicinally important compounds or intermediates by Microwave irradiation technique
Drawing structures and reactions using chem draw®
Determination of physicochemical properties such as logP, clogP, MR, Molecular weight, Hydrogen bond donors and acceptors for class of drugs course content using drug design software Drug likeliness screening (Lipinskies RO5)
Anti -asthmatic drugs
Drugs used in the management of COPD Expectorants and antitussives
Nasal decongestants Respiratory stimulants
Antiulcer agents.
Drugs for constipation and diarrhoea. Appetite stimulants and suppressants. Digestants and carminatives.
Emetics and anti-emetics.
General principles of chemotherapy. Sulfonamides and cotrimoxazole.
Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and fluoroquinolins, tetracycline and aminoglycosides
Urinary tract infections and sexually transmitted diseases. Chemotherapy of malignancy.
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars
Definition and basic knowledge of acute, subacute and chronic toxicity.
Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity and mutagenicity
General principles of treatment of poisoning
Clinical symptoms and management of barbiturates, morphine, organophosphosphorus compound and lead, mercury and arsenic poisoning.
Definition of rhythm and cycles.
Biological clock and their significance leading to chronotherapy.
Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology, Churchil Livingstone Elsevier
Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc Graw-Hill Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs. The Point Lippincott Williams & Wilkins
Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews- Pharmacology
K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical Publishers
(P) Ltd, New Delhi.
Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,
Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata, Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,
N.Udupa and P.D. Gupta, Concepts in Chronopharmacology.
Dose calculation in pharmacological experiments
Antiallergic activity by mast cell stabilization assay
Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and NSAIDS induced ulcer model.
Study of effect of drugs on gastrointestinal motility
Effect of agonist and antagonists on guinea pig ileum
Estimation of serum biochemical parameters by using semi- autoanalyser
Effect of saline purgative on frog intestine
Insulin hypoglycemic effect in rabbit
Test for pyrogens ( rabbit method)
Determination of acute oral toxicity (LD50) of a drug from a given data
Determination of acute skin irritation / corrosion of a test substance
Determination of acute eye irritation / corrosion of a test substance
Calculation of pharmacokinetic parameters from a given data
Biostatistics methods in experimental pharmacology( student’s t test, ANOVA)
Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon Signed Rank test)
*Experiments are demonstrated by simulated experiments/videos
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation Source of Herbs
Selection, identification and authentication of herbal materials Processing of herbal raw material
Good agricultural practices in cultivation of medicinal plants including Organic farming. Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.
Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas, Ghutika,Churna, Lehya and Bhasma.
General aspects, Market, growth, scope and types of products available in the market. Health benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable bowel syndrome and various Gastro intestinal diseases.
Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic, Honey, Amla, Ginseng, Ashwagandha, Spirulina
Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin care, hair care and oral hygiene products.
Herbal Excipients – Significance of substances of natural origin as excipients – colorants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms like phytosomes
Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and Biopiracy Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem.
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and aromatic plants in India.
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments, standard operating procedures, health and hygiene, documentation and records.
Textbook of Pharmacognosy by Trease & Evans. Textbook of Pharmacognosy by Tyler, Brady & Robber. Pharmacognosy by Kokate, Purohit and Gokhale Essential of Pharmacognosy by Dr.S.H.Ansari Pharmacognosy & Phytochemistry by V.D.Rangari
Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy)
Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
To perform preliminary phytochemical screening of crude drugs.
Determination of the alcohol content of Asava and Arista
Evaluation of excipients of natural origin
Incorporation of prepared and standardized extract in cosmetic formulations like creams, lotions and shampoos and their evaluation.
Incorporation of prepared and standardized extract in formulations like syrups, mixtures and tablets and their evaluation as per Pharmacopoeial requirements.
Monograph analysis of herbal drugs from recent Pharmacopoeias
Determination of Aldehyde content
Determination of Phenol content
Determination of total alkaloids
Bioavailability and Bioequivalence: Definition and Objectives of bioavailability, absolute and relative bioavailability, measurement of bioavailability, in-vitro drug dissolution models, in- vitro-in-vivo correlations, bioequivalence studies, methods to enhance the dissolution rates and bioavailability of poorly soluble drugs.
Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra vascular administrations.
Pharmacokinetics parameters - KE ,t1/2,Vd,AUC,Ka, Clt and CLR- definitions methods of eliminations, understanding of their significance and application
Multicompartment models: Two compartment open model. IV bolus
Kinetics of multiple dosing, steady state drug levels, calculation of loading and mainetnance doses and their significance in clinical settins.
Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th edition,Prentice-Hall Inernational edition.USA
Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil B.Jaiswal,Vallabh Prakashan Pitampura, Delhi
Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health Science Press.
Biopharmaceutics; By Swarbrick
Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company,Pennsylvania 1989.
Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia
Brief introduction to Biotechnology with reference to Pharmaceutical Sciences. Enzyme Biotechnology- Methods of enzyme immobilization and applications. Biosensors- Working and applications of biosensors in Pharmaceutical Industries. Brief introduction to Protein Engineering.
Use of microbes in industry. Production of Enzymes- General consideration - Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.
Basic principles of genetic engineering.
Study of cloning vectors, restriction endonucleases and DNA ligase. Recombinant DNA technology. Application of genetic engineering in medicine. Application of r DNA technology and genetic engineering in the production of: Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.
Brief introduction to PCR
Types of immunity- humoral immunity, cellular immunity Structure of Immunoglobulins
Structure and Function of MHC
Hypersensitivity reactions, Immune stimulation and Immune suppressions.
General method of the preparation of bacterial vaccines, toxoids, viral vaccine, antitoxins, serum- immune blood derivatives and other products relative to immunity.
Storage conditions and stability of official vaccines
Hybridoma technology- Production, Purification and Applications Blood products and Plasma Substituties.
Immuno blotting techniques- ELISA, Western blotting, Southern blotting. Genetic organization of Eukaryotes and Prokaryotes
Microbial genetics including transformation, transduction, conjugation, plasmids and transposons. Introduction to Microbial biotransformation and applications.
Mutation: Types of mutation/mutants.
Fermentation methods and general requirements, study of media, equipments, sterilization methods, aeration process, stirring.
Large scale production fermenter design and its various controls.
Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid, Griseofulvin, Blood Products: Collection, Processing and Storage of whole human blood, dried human plasma, plasma Substituties.
B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of RecombinantDNA: ASM Press Washington D.C.
RA Goldshy et. al., : Kuby Immunology.
J.W. Goding: Monoclonal Antibodies.
J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal Society of Chemistry.
Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific Publication.
Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology, 2nd edition, Aditya books Ltd., New Delhi
Laboratory Study, Records and Reports, Disqualification of Testing Facilities
Quality Assurance Guide by organization of Pharmaceutical Products of India. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I WHO Publications.
A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh How to Practice GMP’s – P P Sharma.
ISO 9000 and Total Quality Management – Sadhank G Ghosh
The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excipients and Dosage forms
Good laboratory Practices – Marcel Deckker Series ICH guidelines, ISO 9000 and 14000 guidelines
=======Study of the development of the following classes of drugs, Classification, mechanism of action, uses of drugs mentioned in the course, Structure activity relationship of selective class of drugs as specified in the course and synthesis of drugs superscripted by (*)
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products of the following classes :
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical degradation classification and important products of the following classes: Macrolide: Erythromycin Clarithromycin, Azithromycin.
Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.
Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir, Ritonavir.
Historical development, chemistry, classification and SAR of Sulfonamides: Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*, Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mefenide acetate, Sulfasalazine.
Various approaches used in drug design.
Physicochemical parameters used in quantitative structure activity relationship (QSAR) such as partition coefficient, Hammet’s electronic parameter, Tafts steric parameter and Hansch analysis. Pharmacophore modeling and docking techniques.
Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry. Foye’s Principles of Medicinal Chemistry.
Burger’s Medicinal Chemistry, Vol I to IV.
Introduction to principles of drug design- Smith and Williams. Remington’s Pharmaceutical Sciences.
Martindale’s extra pharmacopoeia. Organic Chemistry by I.L. Finar, Vol. II.
The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
Indian Pharmacopoeia.
Text book of practical organic chemistry- A.I.Vogel.
Sulphanilamide
7-Hydroxy, 4-methyl coumarin Chlorobutanol
Triphenyl imidazole Tolbutamide Hexamine
Dapsone Chlorpheniramine maleate Benzyl penicillin
Preparation of medicinally important compounds or intermediates by Microwave irradiation technique
Drawing structures and reactions using chem draw®
Determination of physicochemical properties such as logP, clogP, MR, Molecular weight, Hydrogen bond donors and acceptors for class of drugs course content using drug design software Drug likeliness screening (Lipinskies RO5)
Anti -asthmatic drugs
Drugs used in the management of COPD Expectorants and antitussives
Nasal decongestants Respiratory stimulants
Antiulcer agents.
Drugs for constipation and diarrhoea. Appetite stimulants and suppressants. Digestants and carminatives.
Emetics and anti-emetics.
General principles of chemotherapy. Sulfonamides and cotrimoxazole.
Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and fluoroquinolins, tetracycline and aminoglycosides
Urinary tract infections and sexually transmitted diseases. Chemotherapy of malignancy.
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars
Definition and basic knowledge of acute, subacute and chronic toxicity.
Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity and mutagenicity
General principles of treatment of poisoning
Clinical symptoms and management of barbiturates, morphine, organophosphosphorus compound and lead, mercury and arsenic poisoning.
Definition of rhythm and cycles.
Biological clock and their significance leading to chronotherapy.
Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology, Churchil Livingstone Elsevier
Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc Graw-Hill Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs. The Point Lippincott Williams & Wilkins
Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews- Pharmacology
K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical Publishers
(P) Ltd, New Delhi.
Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,
Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata, Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,
N.Udupa and P.D. Gupta, Concepts in Chronopharmacology.
Dose calculation in pharmacological experiments
Antiallergic activity by mast cell stabilization assay
Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and NSAIDS induced ulcer model.
Study of effect of drugs on gastrointestinal motility
Effect of agonist and antagonists on guinea pig ileum
Estimation of serum biochemical parameters by using semi- autoanalyser
Effect of saline purgative on frog intestine
Insulin hypoglycemic effect in rabbit
Test for pyrogens ( rabbit method)
Determination of acute oral toxicity (LD50) of a drug from a given data
Determination of acute skin irritation / corrosion of a test substance
Determination of acute eye irritation / corrosion of a test substance
Calculation of pharmacokinetic parameters from a given data
Biostatistics methods in experimental pharmacology( student’s t test, ANOVA)
Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon Signed Rank test)
*Experiments are demonstrated by simulated experiments/videos
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation Source of Herbs
Selection, identification and authentication of herbal materials Processing of herbal raw material
Good agricultural practices in cultivation of medicinal plants including Organic farming. Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.
Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas, Ghutika,Churna, Lehya and Bhasma.
General aspects, Market, growth, scope and types of products available in the market. Health benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable bowel syndrome and various Gastro intestinal diseases.
Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic, Honey, Amla, Ginseng, Ashwagandha, Spirulina
Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin care, hair care and oral hygiene products.
Herbal Excipients – Significance of substances of natural origin as excipients – colorants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms like phytosomes
Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and Biopiracy Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem.
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and aromatic plants in India.
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments, standard operating procedures, health and hygiene, documentation and records.
Textbook of Pharmacognosy by Trease & Evans. Textbook of Pharmacognosy by Tyler, Brady & Robber. Pharmacognosy by Kokate, Purohit and Gokhale Essential of Pharmacognosy by Dr.S.H.Ansari Pharmacognosy & Phytochemistry by V.D.Rangari
Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy)
Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
To perform preliminary phytochemical screening of crude drugs.
Determination of the alcohol content of Asava and Arista
Evaluation of excipients of natural origin
Incorporation of prepared and standardized extract in cosmetic formulations like creams, lotions and shampoos and their evaluation.
Incorporation of prepared and standardized extract in formulations like syrups, mixtures and tablets and their evaluation as per Pharmacopoeial requirements.
Monograph analysis of herbal drugs from recent Pharmacopoeias
Determination of Aldehyde content
Determination of Phenol content
Determination of total alkaloids
Bioavailability and Bioequivalence: Definition and Objectives of bioavailability, absolute and relative bioavailability, measurement of bioavailability, in-vitro drug dissolution models, in- vitro-in-vivo correlations, bioequivalence studies, methods to enhance the dissolution rates and bioavailability of poorly soluble drugs.
Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra vascular administrations.
Pharmacokinetics parameters - KE ,t1/2,Vd,AUC,Ka, Clt and CLR- definitions methods of eliminations, understanding of their significance and application
Multicompartment models: Two compartment open model. IV bolus
Kinetics of multiple dosing, steady state drug levels, calculation of loading and mainetnance doses and their significance in clinical settins.
Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th edition,Prentice-Hall Inernational edition.USA
Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil B.Jaiswal,Vallabh Prakashan Pitampura, Delhi
Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health Science Press.
Biopharmaceutics; By Swarbrick
Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company,Pennsylvania 1989.
Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia
Brief introduction to Biotechnology with reference to Pharmaceutical Sciences. Enzyme Biotechnology- Methods of enzyme immobilization and applications. Biosensors- Working and applications of biosensors in Pharmaceutical Industries. Brief introduction to Protein Engineering.
Use of microbes in industry. Production of Enzymes- General consideration - Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.
Basic principles of genetic engineering.
Study of cloning vectors, restriction endonucleases and DNA ligase. Recombinant DNA technology. Application of genetic engineering in medicine. Application of r DNA technology and genetic engineering in the production of: Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.
Brief introduction to PCR
Types of immunity- humoral immunity, cellular immunity Structure of Immunoglobulins
Structure and Function of MHC
Hypersensitivity reactions, Immune stimulation and Immune suppressions.
General method of the preparation of bacterial vaccines, toxoids, viral vaccine, antitoxins, serum- immune blood derivatives and other products relative to immunity.
Storage conditions and stability of official vaccines
Hybridoma technology- Production, Purification and Applications Blood products and Plasma Substituties.
Immuno blotting techniques- ELISA, Western blotting, Southern blotting. Genetic organization of Eukaryotes and Prokaryotes
Microbial genetics including transformation, transduction, conjugation, plasmids and transposons. Introduction to Microbial biotransformation and applications.
Mutation: Types of mutation/mutants.
Fermentation methods and general requirements, study of media, equipments, sterilization methods, aeration process, stirring.
Large scale production fermenter design and its various controls.
Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid, Griseofulvin, Blood Products: Collection, Processing and Storage of whole human blood, dried human plasma, plasma Substituties.
B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of RecombinantDNA: ASM Press Washington D.C.
RA Goldshy et. al., : Kuby Immunology.
J.W. Goding: Monoclonal Antibodies.
J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal Society of Chemistry.
Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific Publication.
Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology, 2nd edition, Aditya books Ltd., New Delhi
Laboratory Study, Records and Reports, Disqualification of Testing Facilities
Quality Assurance Guide by organization of Pharmaceutical Products of India. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I WHO Publications.
A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh How to Practice GMP’s – P P Sharma.
ISO 9000 and Total Quality Management – Sadhank G Ghosh
The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excipients and Dosage forms
Good laboratory Practices – Marcel Deckker Series ICH guidelines, ISO 9000 and 14000 guidelines
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