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Syllabus of M. Pharm Session: 2013-2014 Examination: 2014

Department of Faculty of Science University of Rajshahi

2 Ordinance of Master of Pharmacy. (1 year course) Duration of the Course: The M.Pharm course consisting of General and Thesis Groups shall extend over a period of one academic year. The degree has to be completed within a minimum of one academic year and in not more than three academic years from the date of first admission. Admission Requirements: For admission to the M.Pharm course in any subject of the faculty a student must have the following qualifications: B.Pharm of four years duration of this University or of a recognized University in the subject or similar subject to be decided by the relevant department. A maximum of two years break of study after passing B.Pharm Honours examination shall be allowed. Candidates appearing at the Honours final examination from this University may be admitted provisionally to the Master of Pharmacy (M.Pharm) classes pending publication of their examination results: the confirmation of their admission being subject to their passing the examination as and when the results of examination are published. Course and Distribution of Marks: The total marks of Master Pharmacy examination (General and Thesis Group) shall be 1000 (10 course units, 40 credits) for all the subjects. The marks shall be distributed among the Theory Courses, Class assessment /Tutorial /Terminal /Home assignments, Viva Voce, Practical/Dissertation, Projects, Field Works, In-plant Training etc as follows: Courses Marks Units Credits a. Theory* 600 6 24 Class assessment /Tutorial/Terminal/Home assignment** 100 1 4 Viva Voce 100 1 4 b. Practical/Practical and In-plant Training/Field Work Project etc. 200 2 8 (30% marks to be allotted for continuous Lab assessment)* OR c. Thesis/Dissertation including Viva-Voce 200 2 8 (and/or Seminar)/In-plant training etc. 1000 10 40 * The Departments of (i) Mathematics and (ii) Applied Mathematics shall offer two additional Theory courses (2 units) instead of Practical courses as mentioned in (b).

** 20% of the assessment marks shall be awarded for attendance in the class on the basis of the following table: Attendance Marks Attendance Marks Attendance Marks 95-100% 20% 90-<95% 18% 85-<90% 16% 80-<85% 14% 75-<80% 12% 70-<75% 10% 65-<70% 8% 60-<65% 6% <60% 00%

There shall be a minimum of 3 lecture periods per week totaling 60 lectures in an academic year for each theory course of 1.0 unit. There shall be 15-18 Laboratory hours per week totaling 300- 360 Lab-periods in an academic year for each Practical course of 2 units. Class assessment/Tutorial/Terminal/Home assignment examination on the Theory courses (at least 3 for 1 unit course) shall be taken by the course teacher(s) as internal evaluation during the progress of the course. The duration of examination of Theory course shall be 4 hours for 1 unit course. The total duration of Practical examination shall be 24-48 hours for 2 units (4-6 hours per day). Class assessment/Tutorial/Terminal/Home assignment and Lab-assessment marks (average) are to be submitted by the teachers concerned to the Chairman of the relevant examination Committee before the commencement of the final examination. Consolidated average marks of Class assessment /Tutorial /Terminal /Home assignment, Viva Voce, Lab-assessment and Practical courses are to be submitted to the Controller of examination by the Chairman of the relevant examination Committee before finalizing the result. Eligibility for Master of Pharmacy Examination: In order to be eligible for taking up the M.Pharm examination, a candidate must have pursued a regular course of study by attending not less than 75% of the total number of classes held (Theoretical, Practical, Class assessment /Tutorial /Terminal /Home assignment) provided that 3 the Academic Committee of the Department on special grounds and on such documentary evidence as may be necessary, may condone the cases of shortage of attendance ordinarily not below 60%. A candidate appearing at the examination under the benefit of this provision shall have to pay in addition to the examination fees, the requisite fee prescribed by the Syndicate for the purpose. A candidate, who failed to appear at the examination or fails to pass the examination, may on the approval of the relevant Department be readmitted to the following session. Admission to Master of Pharmacy Examination: Every candidate for admission to M.Pharm examination shall submit his/her application in the prescribed form together with certificates of attendance and fulfill all other conditions prescribed by the University. The application shall be submitted through the Chairman of the Department and Provost of the Hall concerned so as to reach the Controller of examinations at least six weeks before the date fixed for the commencement of the examination. Medium of Questions and Answers: Questions shall be made in English. The medium of answer in the examination of all courses shall be in English. Thesis/Dissertation: At least three copies of Thesis/Dissertation (typed, printed and hard-bound) shall have to be submitted to the Chairman of the relevant Examination Committee within the scheduled date (ordinarily three months after the completion of the written examination) of submission. One copy approved for M.Pharm degree shall be sent by the Chairman of the respective Examination Committee to the Departmental Seminar/University Library for future reference. Course Completion, Holding of Examination and Publication of Results: Courses should be conducted according to the Academic calendar circulated by the Department concerned and be completed within eight months from the commencement of the courses. The Practical examinations may be conducted immediately after the completion of written theory examination. The time-limit for the publication of the results of the M.Pharm examination shall ordinarily be six weeks (for General Group) from the date of completion of the written/practical/viva voce (whichever is the last) examination. The Grading Systems: Credit Point (CP): The credit points achieved by an examinee for 1 (one) unit course shall be 4 (four). Letter Grade (LG) and Grade Point (GP): Letter Grades, corresponding Grade Points and Credit Points shall be awarded in accordance with provisions shown below: Table of LG, GP and CP for credit courses Numerical grade LG GP/unit CP/unit 80% or its above A+ (A plus) 4.00 4 75% to less than 80% A (A regular) 3.75 4 70% to less than 75% A-(A minus) 3.50 4 65% to less than 70% B+ (B plus) 3.25 4 60% to less than 65% B (B regular) 3.00 4 55% to less than 60% B- (B minus) 2.75 4 50% to less than 55% C+ (C plus) 2.50 4 45% to less than 50% C (C regular) 2.25 4 40% to less than 45% D 2.00 4 Less than 40% F 0.00 0 Incomplete I -- 0 Absence from the final examination shall be considered incomplete with the letter grade “I”. Grade Point Average (GPA) and Total Credit Point (TCP): The weighted average of the grade points obtained in all the courses by a student and Total Credit Point shall be calculated from the following equations: GPA = Sum of [(CP)i x (GP)i] / sum of (CP)i and TCP = Sum of (CP)i Where (GP)i = grade point obtained in individual course, (CP)i = credit point for respective course, GPA = grade point average obtained, and TCP = total credit point obtained. GPA shall be rounded off up to 2 (two) places after decimal to the advantage of the examinee. For instance, GPA=2.112 4 shall be rounded off as GPA=2.12. An illustration of calculating GPA and CGPA: Suppose a student has completed six courses in M.Pharm examination and obtained the following grades: M.Pharm course Credits (CP) Grade (LG) GP 501 4 A 3.75 502 4 A+ 4.00 503 4 B+ 3.25 504 4 B- 2.75 505 4 C 2.25 506 4 F 0.00

( ) ( ) ( ) ( ) ( ) +++++ 000425247524253400447534 .).(..... 0064 GPA = == .66672 +++++ 444444 24 His/her GPA is: 2.67 LG corresponding to GPA = 2.67 is “B-”. Award of Degree, Promotion and Improvement of Results: Award of Degree: The degree of Master of Pharmacy in any subject shall be awarded on the basis of GPA obtained by a candidate in M.Pharm. In order to qualify for the M.Pharm degree a candidate must have to obtain within 3 (three) academic years from the date of first admission: (i) a minimum GPA of 2.50, (ii) a minimum GP of 2.00 in the Practical/Thesis, and (iii) a minimum TCP of 36. The result shall be given in GPA with the corresponding LG (Table of LG, GP and CP) in bracket. For instance, in the example cited above the result is “GPA = 2.67 (B-)”. Publication of Results: The result of a successful candidate shall be declared on the basis of GPA. The transcript in English shall show the course number, course , credit, grade and grade point of individual courses, GPA and the corresponding LG. Result Improvement: A candidate obtaining a GPA of less than 2.75 at the examination shall be allowed to improve his/her result, only once as an irregular candidate within 3 academic years from the date of first admission. The year of examination, in the case of a result improvement, shall remain same as that of the regular examination. His/her previous grades for Practical courses, Class assessment/Tutorial/Terminal/Home assignment, Thesis /Dissertation /Project/In-plant training courses shall remain valid (except the Theory Viva voce)***. If a candidate fails to improve GPA, the previous result shall remain valid. ***However such previous grades may be re-evaluated afresh by the Department of Statistics during the regular examination. This ordinance shall come in force from the session 2010-2011 onwards and the previous one shall stand cancelled. Students under previous ordinance shall have to complete their programmed in special consideration if such students remain in the programmed after the due date. Amendment: Any amendment to this ordinance shall be processed through the Faculty of Science and passed by the academic Council of Rajshahi University. --0--

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General Group (Group-A) Session: 2013-2014, Examination: 2014 Course Unit Marks Credit Theory 6 600 24 Practical 2.0 200 8 Class assessment 0.5 50 2 Home assignment / Project work 0.5 50 2 Viva-voce 1.0 100 4 Total 10 1000 40

Course Course Title Unit Mark Credit 501 Advanced Analytical Chemistry 1.0 100 4 502 Advanced Medicinal Chemistry 1.0 100 4 503 Advanced Pharmacology and Toxicology 1.0 100 4 504 Advanced Molecular Biology 1.0 100 4 505 Advanced Pharmaceutical Technology 1.0 100 4 506 Advanced Biopharmaceutics and Pharmacokinetics 1.0 100 4 507 Practical (30% marks to be allotted for continuous Lab assessment)** 2 200 8 508 Class assessment 0.5 50 2 509 Home assignment 0.5 50 2 510 Viva-voce 1.0 100 4 Total 10 1000 40 ** a) Practical Examination-140 b) Lab assessment-60 Thesis Group (Group-B) Session: 2013-2014, Examination: 2014 Course Unit Marks Credit Theory 6 600 24 Thesis 2.0 200 8 Class assessment 0.5 50 2 Home assignment 0.5 50 2 Viva-voce 1.0 100 4 Total 10 1000 40

Course Course Title Unit Mark Credit 501 Advanced Analytical Chemistry 1.0 100 4 502 Advanced Medicinal Chemistry 1.0 100 4 503 Advanced Pharmacology and Toxicology 1.0 100 4 504 Advanced Molecular Biology 1.0 100 4 505 Advanced Pharmaceutical Technology 1.0 100 4 506 Advanced Biopharmaceutics and Pharmacokinetics 1.0 100 4 507 Thesis (30% marks to be allotted for thesis Presentation)** 2 200 8 508 Class assessment 0.5 50 2 509 Home assignment 0.5 50 2 510 Viva-voce 1.0 100 4 6 Total 10 1000 40 ** a) Thesis-140 b) Thesis Presentation-60

Master of Pharmacy Course: 501 (Unit – 1) Course Title: Advanced Analytical Chemistry Full marks - 100

1. Nuclear Magnetic Resonance (NMR) Spectroscopy: Advanced Techniques and Applications NMR: 1H and 13C NMR, principles, instrumentation, principles of decoupling, gated decoupling, difference spectroscopy, relaxation process, population transfer, selective polarization transfer, INEPT, basic two dimensional sequence, heteronuclear shift correlation, application of DEPT, 1H-1H COSY, HMBC, HMQC, HOHAHA (TOCSY), NOE’s in structure elucidation of organic compounds. NMR in drug screening, reaction monitoring etc. Applications of NMR in medical sciences. 2. Electron Spin Resonance (ESR) Spectroscopy: Introduction, principles, instrumentation and application in detection of free radical reactions in chemical and biological systems. 3. Mass Spectroscopy (MS): Theory, instrumentation and ionization methods (FAB, ESI, MALDI, FD, etc.). Application of HRIEMS, MS-MS, GC-MS, LC-MS. Mass spectrometers (MALDI TOF, ES) in structure elucidation of small and macromolecules . 4. High Performance Liquid Chromatography (HPLC): Normal phase, reversed phase, ion exchanges and ion pairing techniques, chiral HPLC. Application of HPLC in analysis of drugs in pharmaceutical preparations and biological fluids. 5. Separation Technology: a) Gel filtration chromatography: Principle, materials, application. Introduction, instrumentation, detection, modes of separation, efficiency & resolution of gel and capillary electrophoresis, related techniques as temperature gradient gel electrophoresis, SDS-PAGE & its zymography. b) Ion-exchange chromatography: Principle, exchangers, ion exchange column, capacity, techniques and its pharmaceutical application. c) Affinity chromatography: principles, uses, limitation. 6. Nephelometry and Turbidimetry: Light scattering (Tyndall Rayleigh & Raman scattering), theory, instrumentation, turbidimetric titrations, and applications of nephelometry and turbidimetry, comparison of spectrophotometry with nephelometry & turbidimetry. 7. Refractometry: Specific and molar refraction, factors affecting refractive index, theory, various refractometers, quantitative analysis, application of refractometry, determination of critical micelle concentration (CMC).

Books Recommended: 1. One and two Dimensional NMR spectroscopy. By Atta-ur-Rahman, Elsevier, 1989. 2. Organic Spectroscopy. By D.W. Brown, A.J. Floyd, and M.Sainsbury, John Wiley and Sons, 1988. 3. Modern NMR Techniques for Chemistry Research, by A.E. Hunter. 4. Proton and Carbon-13 NMR Spectroscopy. By R.J. Abraham and P.Loftus. 5. Principles of Instrumental Analysis. By D.A. Skoog. 6. Instrumental methods of chemical analysis by B.K. Sharma. 7. Introduction to Organic Laboratory Techniques. By D.L. Pavia, G.M. Lampman and G. S. Criz. W.B. Saunders Company, 1976. 8. Natural Products-a Laboratory Guide. By Raphel Lkan, Academic Press Inc,1991. 9. Instrumental methods of chemical analysis by G. R. Chatwal & S.K. Anand 10. Introduction to instrumental analysis by R.D. Braun. 11. Analytical Chemistry by G.D. Christian

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* Other Books will be indicated by respective teachers

Master of Pharmacy Course: 502 (Unit – 1) Course Title: Advanced Medicinal Chemistry Full marks - 100

1. Drug Design: Synthesis of compounds in accordance with the molecular structure, biological activity concept with special references to analgesics, neuromuscular blocking agents, anti- fertility drugs and compounds containing bridge head nitrogen atom and bactericidal & bacteriostatic agents (sulphonamides, mercury compounds and antiseptics). 2. Molecular Mechanism of Drug Resistance: Drug resistance with reference to cancer and infectious diseases, measures to overcome drug resistance. Novel molecular target discovery. 3. Biosynthesis: Biosynthetic pathways and actions of steroidal hormones, alkaloids, carbohydrates and nucleotides. 4. Antioxidants and Free Radicals: Antioxidants. Natural body antioxidants; Super oxide theory and Oxygen Toxicity, ROS (Reactive Oxygen Species) and LP (Lipid Peroxidation) in human pathology and diseases. Antioxidant defense system; Healing power of H2O2; formation of free radicals, free radical chain reaction, free radicals and useful species, free radicals in ageing process and diseases like arteriosclerosis, ischemic heart diseases and neurodegradative conditions, Toxicity of free radicals and prevention of free radical damage by antioxidants. 5. Proteins And Nucleic acids: Chemistry of proteins. extraction, isolation and purification, membrane structure, conformation and protein folding. biological functions of proteins and factors affecting protein folding. Chemistry of nucleic acids. structure, extraction, isolation and transcription. 6. Metabolite antagonism: Historical development, sulfonamides and Fildes theory of antimetabolites, active site-directed irreversible enzyme inhibitors, mechanism-based enzyme inhibitors, antifolates, sulfonamides and sulfones, dihydrofolate reductance inhibitors, synergism of sulfonamides and dihydrofolate reductance inhibitors, amino acid antagonists, vitamin antaginists, pyrimidine and purine antimetabolites.

Books Recommended: 1. An Introduction to Medicinal chemistry, 2nd.ed. 2001, G.L.Patrick, Oxford University press. 2. Wilson and Gisvolt’s Text Book of Organic, Medicinal and Pharmaceutical Chemistry, 10th ed. Lippincott-Raven, 1998 3. Advanced Practical Organic Chemistry, 2nd. ed., by J. Leonard et al.Academic press. 4. Advanced Organic Chemistry, Bernard Miller, Prentice Hall. 1995 5. Advanced Organic Chemistry, Jerry march, Wiley Interscience. 6. Mechanism and theory of Organic Chemistry, Lowry and Richardson, Harper. 7. Physicochemical Principles of Pharmacy, 3rd ed. 1998, A.T. Florence and A.D. Palgrave.

* Other Books will be indicated by respective teachers

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Master of Pharmacy Course: 503 (Unit – 1) Course Title: Advanced Pharmacology and Toxicology Full marks – 100

1. Receptor Pharmacology : Bindings desolation or the steric and allostoric bindings sites, allosteric moulatory, Molecular and cellular mechanisms, pharmacological responses or pathogenic role by their activation and clinical importance’s of (1) Serotonin receptor (2) Glutamate receptors, (3) GABA and its receptors, (4) Catecholamine receptors (α- and β-adrenoceptors, dopamine receptors), (5) Acetylcholine receptors (nicotinic and muscarinic receptors), (6) Opioid receptors. 2. Pharmacology of Channels and Enzymes: Transduction mechanisms as targets of drug action, Function and pathophysiology of K+ channels and Ca+2 channels related to heart disease and the pharmacology of their inhibitors. Pharmacology of Na+/K+ ATPase and gap junctions. 3. Cardiovascular Pharmacology: a) Pathophysiology of Heart disease: Atherosclerosis, Angina, Myocardial infarction, Cardiac hypertrophy, Atrial fibrillation, Congestive heart failure. b) Drugs used in cardiovascular diseases: i) Digitalis and allied drugs ii) Antihypertensive drugs: iii) Antiarrythmic drugs iv) Thrombolytics and lipid lowering agents. 4. Vasodilators: Nitric oxide - Biosynthesis of nitric oxide and its control, Degradation and carriage of nitric oxide, Effects of nitric oxide, Therapeutic use of nitric oxide and nitric oxide donors, Inhibition of nitric oxide, Clinical conditions in which nitric oxide may play a part. 5. Neuropharmacology: a) Pathophysiology of CNS degenerations functional ares of age related senile illnes memory. b) Diseases and treatment of Neurodegenerative disorders -Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, Neurodegenerative prion disease. eplepsi schizoprenia. 6. Cancer Biology and Therapy: Introduction to biology of cancer, modes of treatment: radiotherapy, chemotherapy, surgery, biological therapy including immunology and gene therapy. 7. Ophthalmology: Overview of ocular physiology and biochemistry, ocular structure, delivery strategies, corneal grafting, cataract, contact lens, chemotherapy of microbial and viral diseases of the eye, steroid and other anti-inflammatory drugs, drugs used in the treatment of glaucoma, drugs affect the pupil size. 8. The Mechanism of Toxin Action: General mechanisms of toxin-induced cell damage and death – hepatotoxicity and nephrotoxicity, Mutagenesis and carcinogenecity – Biochemical mechanisms of mutagenesis, Carcinogenesis–genotoxic and epigenetic carcinogens, Teratogenesis and drug-induced foetal damage, Allergic reactions to drugs. 9. Reactive Intermediates: Types of metabolically generated reactive intermediates and their role in drug toxicity. Epoxidation and drug toxicity, N-oxidation and drug toxicity, toxicity and sulphur xenobiotics. 10. Phenotype pharmacology, pharmacogenomics.

References of Books: 1. The Pharmacological Basis of Therapeutics – by Goodman and Gilman. 2. Pharmacology – by H.P. Rang et al. 3. Pharmacology – by Lippincott et al. 4. Pharmacology – by Kalant et al. 5. Basic and Clinical Pharmacology – by Bertram G. Katzung. 6. Pharmacology and Therapeutics – by R.S. Satoskar et al. 7. Medical Pharmacology – by Goth. 8. Essentials of Medical Pharmacology – by K.D. Tripatti.

* Other Books will be indicated by respective teachers

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Master of Pharmacy Course: 504 (Unit – 1) Course Title: Advanced Molecular Biology Full marks – 100

1. Regulation of Gene Expression: a) Characterization and identification of cis and trans elements, methodology, mechanism of transcription repression by methylation, silencers. b) Regulation in Prokaryotes- Transcriptional regulation in prokaryotes (inducible and repressible system, positive regulation and negative regulation); Operon concept – lac., trp., and ara. operons. c) Regulation in Eukaryotes: Regulatory strategies in Eukaryotes, Gene alteration (Gene loss, Gene amplification, Gene rearrangement: the joining of coding sequences) Transcriptional control by hormones, Regulation mediated through transcription factors, Regulation of enhancer activity, Methylation, Regulation of processing, Translational control. 2. Gene Replacement and Transgenic Animals: Cloning, purposes and risks of cloning, stem cells, definition & classification, generation and uses of transgenic & knockout/gene targeting animal models to study genetic diseases. 3. Gene Therapy: Central concept of gene therapy, basic molecular mechanism of gene transfer, prerequisite of human gene therapy, biological basis of gene therapy strategies, vehicles for gene transfer, Antisence oligonucleotides and RNAi, clinical gene therapy studies, gene therapy for hereditary disease, gene therapy for cancer, gene therapy for HIV. 4. Repair Mechanism of DNA: DNA damage, Mechanism of different types of DNA repair system in bacteria and their relation with carcinogenesis. 5. Bioinformatics: Definition and concepts, importance of bioinformatics, biological database, primary sequence database, protein sequence database, DNA sequence database. Multiple sequence alignment and importance of multiple sequence alignment for drug design. 6. Basic Immunity: Natural and acquired immunity, Innate and adaptive immunity, Effector mechanisms of phagocytes, natural killer (NK) cells, T lymphocytes and B lymphocytes in immune responses; Cytokines and their roles in immune responses. 7. Biotechnology Products: Biotechnological medicine, Structure, Biosysnthesis, Production and characterization of current biotech products; Insulin, growth hormone, antibiotics, interleukins, and interferon, vaccines, monoclonal antibody based pharmaceutical, Follicle stimulating hormone (FSH), transtuzumals.

Books Recommend: 1. Cellular and Molecular Immunology by Abul K Abbas, Andrew H Lichtman, Jordan S Pober 2. Immunology by Ivan Roitt, Jonathan Brostoff , David Male 3. Molecular Biology by PC Turner, AG Mclennam, AD Bates 4. The Cell: A molecular Approach by Alberts B et al 5. Molecular Cell Biology by Lodish et al 6. Molecular Biology of Cells by Alberst et al 7. Applied therapeutics by young kode kihble et.al. 8. Hand book of Drug Interaction by karalliedde & Hanry

* Other Books will be indicated by respective teachers

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Master of Pharmacy Course : 505 / Unit – 0.75 Subject: Advanced Pharmaceutical Technology Full marks - 75

1. Advanced Sustained Release Drug Delivery System : Rate preprogrammed drug delivery systems, activation modulated drug delivery systems, feedback regulated drug delivery systems, site targeting drug delivery systems. 2. Advanced drug Delivery Systems : Transdermal drug delivery system, mucosal drug delivery system, nasal drug delivery system, liposomes and nanoparticles drug delivery system, Drug delivery to the lungs, biodegradable drug delivery system. 3. Total Parenteral Nutrition (TPN) : Introduction, clinical aspects, formulation of total parenteral nutrition, aspects of stability and compatibility, aseptic production, methods and equipments. Basic concepts of probiotics & pre-biotics. 4. Pilot Plant Scale-Up Techniques : Primary function of the pharmaceutical pilot plant, factors to be considered during development, reporting responsibilities, personnel requirements, space requirements, review of the formula, raw materials, relevant processing equipments, production rates, process evaluation, master manufacturing procedures, GMP considerations, pilot plant design for tablet development. 5. Biotechnology Preparations/ Formulation of Biotech Products : Definitions, historical use and applications, composition, preparation, physicochemical considerations, short study of current biotech products e.g. hematopoietic growth factors, interleukins and interferons, insulin, growth hormones, vaccines, monoclonal antibody-based pharmaceuticals, recombinant tissue type plasminogen, recombinant human deoxyribonuclease, follicle stimulating hormone(FSH), quality control, storage and stability of biotech products.

Recommended books: 1. Remington’s Pharmaceutical Sciences 2. Dispensing of Pharmaceutical Students – Cooper and Gunn 3. Dispensing of Medication 4. Bentley’s Textbook of Pharmaceutics 5. An Introduction to Pharmaceutical Formulations – Fishburn 6. Pharmaceutical Dosage Forms – Ansel 7. Pharmaceutics and Pharmacy Practice – Banker and Chalmers 8. The Art, Science and Technology of Pharmaceutical Compounding – Loyd V. Allen Jr. 9. Theory and practice of Industrial Pharmacy – Lachmann 10. American Pharmacy- Sprowl 11. Pharmaceutics – Aulton 12. Trgeted and controlled Drug Delivery, Novel.

* Other Books will be indicated by respective teachers

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Master of Pharmacy Course: 506 (Unit – 1) Course Title: Advanced Biopharmaceutics and Pharmacokinetics Full marks - 100

1. Biopharmaceutics Considerations in Drug Product Design : Rate limiting step in drug absorption, pharmaceutics factors affecting drug bioavailability, physicochemical nature of the drug, formulation factors affecting drug dissolution and bioavailability, in vitro dissolution testing, compendial methods of dissolution, methods for testing enteric coated products, meeting dissolution requirements, unofficial methods of dissolution testing, problems of variable control in dissolution testing, in vitro-in vivo correlation of dissolution, failure of correlation of in vitro dissolution to in vivo absorption, biopharmaceutics considerations, pharmacodynamic considerations, drug product considerations, patient considerations, route of drug administration considerations, clinical example. 2. Biopharmaceutics of Modified Release Drug Products: Modified release drug products, biopharmaceutic factors, dosage form selection, drug release from matrix, advantages and disadvantages of extended release products, kinetics of control release dosage forms, pharmacokinetic simulation of extended release products, types of extended release products, considerations in the evaluation of modified release products, regulatory studies for the evaluation of in vivo bioavailability data. 3. Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs : Elimination of protein therapeutics, distribution of protein therapeutics, pharmacodynamics of protein therapeutics, protein binding of protein therapeutics, interspecies scaling, heterogeneity of protein therapeutics, chemical modification of protein therapeutics, immunogenicity. 4. Physiologic Pharmacokinetic Model, Mean Residence Time and Statistical Moment Theory: Physiologic pharmacokinetic models mean residence time (MRT), statistical moment theory (SMT), mean absorption time (MAT) and mean dissolution time (MDT), selection of Pharmacokinetic models. 5. Pharmacogenetics (PGt) and Pharmacogenomics (PGx): Introduction; polymorphisms; adverse drug reactions related to genetic differences; genetic polymorphism in drug metabolism, transport and drug targets; PK/PD considerations and PGt/PGx. 6. Data Handling in Pharmaceutical Systems: Variability and variables, mean, median, mode, standard deviation, standard error of mean, bias, precision and accuracy, ways of expressing accuracy, significant figures. 7. Designing & methodology of experiments: a) Introduction. b) Finding a research problem, information gathering and knowledge building, research questions and hypothesis, statement of objectives. c) Planning of research, research designs, design and conduct of clinical trials, data collection, research instrument, types of questionnaire and qualities of a good questionnaire. d) Data processing and analysis (ANOVA, confidence limit, test of significance (F test, student t test), the Q test,), statistical software used in data analysis (SPSS, MS-Excel, Statistica, GraphPad Prism).

Recommended books: 1. Biopharmaceutics and Clinical pharmacokinetics-M. Gibaldi 2. Biopharmaceutics and Clinical pharmacokinetics-Notari 3. Biopharmaceutics and relevant pharmacokinetics-T. G. Wagner 4. Biopharmaceutics and Drug interactions-Cadwallader 5. Pharmacokinetics-M. Gibaldi andD. Perrier 6. Analytical Chemistry by G.D. Christian 7. Remington: The science & practice of pharmacy 8. Handbook of drug interaction – Lakshman Karalliedde & John A Henry. 9. Biostatistics and research methodology: Prof. Md. Shahidullah

* Other Books will be indicated by respective teachers

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Master of Pharmacy Course: 507 (Unit - 2.00) Course Title: Practical Full marks - 200

Practical: 501/ Advanced Analytical Chemistry (Marks : 35) 1. Calibration of UV spectrometer through absorbance and wavelength checks. 2. Determination of effects of slit width and scanning speed on the UV absorption spectrum of a given drug. 3. Assay of caffeine and sodium benzoate injection by simultaneous equation method and by absorbance. 4. Acquisition of 1H-NMR spectrum of simple organic molecules and assignments of the signals to the structures. 5. Recording of IR absorption spectrum of a drug using KBR discs thin film techniques. 6. Determination of paracetamol in plasma using reversed phase HPLC. 7. Determination of amount of phenoberbitone in phenoberbitone tablets. 8. Gas chromatographic dtermination of the composition of fatty acid in an oil. 9. Identity test of drug molecules by TLC examination. Workshop: Application of spectroscopic technique for structure elucidation of organic molecules. Practical: 502/ Advanced Medicinal Chemistry (Marks : 35) Basic Laboratory Techniques 1. Record keeping, safety, methods of purifying solvents and reagents, setting up reactions, monitoring reactions, working up reactions, preliminary cleanup of reaction products, decolorization. 2. Purification of products: Recrystallization of impure solids, separation by acid base extraction. Various chromatographic techniques: Column chromatography (CC), thin layer chromatography(TLC) high performance liquid chromatography(HPLC) Computer Methods 1. Chemical structure drawing using chemi draw and others. 2. Using PC spartan for molecular modeling and computational chemistry. Experimental Various preparations illustrating selected techniques and synthetic approaches such as: Esterfication of benzoic acid, Synthesis of methyl benzoate, hydrolysis of glycosidal compounds, nitration of methyl benzoate, preparation of 1-bromobutane, an SN2 reaction, dehydration of cyclohexanol, reduction of diphenyl ketone with sodium borohydride, preparation of adipic acid, diels-alder reaction, catalytic reduction etc.Isolation of alkaloid and essential oil etc. Practical: 503/ Advanced Pharmacology And Toxicology (Marks : 30) 1. Determination of protein concentration by Lowry and method. 2. Colorimetric analysis of different drugs from blood sample. 3. Effect of agonists and antagonists on the contraction and relaxation response of the smooth muscles. 4. Effects of drugs on heart. 5. Study of liver and kidney toxicity. 6. Toxic effects of drugs on hematological parameters. 7. Histopathological study of different organs after drug administration.

Practical: 504/ Advanced Molecular Biology (Marks : 35) Techniques used in immunology: Radioimmunoassay (RIA), fluorescence immunoassay (FIA), luminescence immunoassay (LIA), Enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunosorbent spot (ELISPOT), Immunoprecipitation, Western blotting, Flow cytometry, Immunofluorescence & immunohistochemistry, Transgenic animals & Gene knockout, Isolation of Nucleic acid from prokaryotic & eukaryotic cell, practical modifications to PCR techniques as nested PCR, inverse PCR, RT-PCR, assembly PCR, asymmetric PCR, Q-PCR & QRT-PCR

Practical: 505/ Advanced Pharmaceutical Technology (Marks : 35) 1. Preparation of Suppositories 2. Preparation of Microcapsule and tablets 3. Particle size analysis

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Practical: 506/ Advanced Biopharmaceutics & Pharmacokinetics (Marks: 30) 1. In vitro study of bioavailability of drug: (a) Disintegration and dissolution tests of solid dosage forms. 2. In vivo study of bioavailability of drug: (a) Determination of concentration of aspirin in urine after oral administration (b) Determination of paracetamol in blood after oral administration.