Scheme of Instruction and Evaluation for M. Pharmacy




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Osmania University Syllabus for M. Pharmacy

(Pharmacology)

(w.e.f. academic year 2009-10)


FACULTY OF TECHNOLOGY HYDERABAD


Scheme of Instruction and Evaluation for M. Pharmacy

(Pharmacology)

I – Semester – Revised-2009



Subject Code

Subject / Paper

Theory / Practical

Instruction Hours per week

Evaluation

Duration of External Examination
















Theory

Practical

Internal

External




M.PCOL.T.1.101

Pharmaceutical Analytical Techniques

Theory

4

---

30

70

3

M.PCOL.T.1.102

Drug Design and Molecular Pharmacology

Theory

4

---

30

70

3

M.PCOL.T.1.103

Bioassays and Screening Methods

Theory

4

---

30

70

3

M.PCOL.T.1.104

Principles of Toxicology

Theory

4

---

30

70

3

M.PCOL.P.1.105

Pharmaceutical Analytical Techniques

Practical

-

6

30

70

6

M.PCOL.P.1.106

Bioassays and Screening Methods

Practical

--

6

30

70

6

M.PCOL.T.1.107

Scientific and Technical Writing (SAIL)

Tutorial

2

-

A/B/C/D

-

-

M.PCOL.1.108

Seminar

Theory




8

50
















18

20

230

420






Scheme of Instruction and Evaluation for M. Pharmacy

(Pharmacology)

II– Semester – Revised-2009



Subject Code

Subject / Paper

Theory / Practical

Instruction Hours per week

Evaluation

Duration of External Examination
















Theory

Practical

Internal

External




M.PCOL.T.1.201

Intellectual property rights & Regulatory affairs

Theory

4

---

30

70

3

M.PCOL.T.1.202

Advances in Pharmacology

Theory

4

---

30

70

3

M.PCOL.T.1.203

Biopharmaceutics and Pharmacokinetics

Theory

4

---

30

70

3

M.PCOL.T.1.204

Pharmacology & Pharmaco therapeutics

Theory

4

---

30

70

3

M.PCOL.P.1.205

Advances in Pharmacology Practicals.

Practical

--

6

30

70

6

M.PCOL.P.1.206

Biopharmaceutics and Pharmacokinetics

Practical

--

6

30

70

6

M.PCOL.T.1.207

Entrepreneurship Management (SAIL)

Tutorial

2

-

A/B/C/D

-

-

M.PCOL.1.208

Seminar

Theory




8

50
















18

20

230

420





SAIL: Self assess Instrumentation Learning


Scheme of Instruction and Evaluation for M. Pharmacy

(Pharmacology)


Semester III and IV

DISSERTATION – Original research work carried out by the candidate under the guidance of regular teaching faculty/visiting faculty of the department should be submitted in a bound form.

Evaluation of the dissertation shall be done by external and internal examiners appointed by the university.

Dissertation viva-voce Grade A/B/C/D/F

Dissertation report Grade A/B/C/D/F

A. Excellent B. Very good C. Good D. Fair F. Fail


PHARMACEUTICAL ANALYTICAL TECHNIQUES

Subject Code: M.PCOL.T.1.101 Sessional : 30

Period / Week: 4 Examinations : 70

Nature of Exam: Theory Duration of Exam : 3 hrs

UNIT – I

a) UV-Visible Spectroscopy: Basic principles, interaction of electromagnetic radiation with matter and its effects (electronic transitions). Concept of chromophore and auxochrome, effect of conjugation, solvent and pH. Instrumentation (components and their significance). Absorption spectra of organic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs including multicomponent analysis. Woodward-Fieser rules for calculating absorption maximum for unsaturated hydrocarbons. Difference and derivative spectra.

b) Infra-Red Spectroscopy: Interaction of infrared radiation with organic molecules and it’s effects on bonds. Instrumentation- Dispersive IR spectrophotometers and Fourier transform spectrophotometers. Sample handling for IR spectroscopy. Interpretation of IR spectra. Brief note on ATR. (Attenuated Total Reflectance).

UNIT – II

Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR, instrumentation (components and their significance). Chemical shifts concept, spin- spin coupling, spin-spin decoupling, shielding and deshielding, solvents. signal multiplicity phenomena in high resolution PMR. Interpretation of PMR spectra.

Brief introduction about Carbon-13 NMR and 2D NMR Spectroscopy.

UNIT – III

Mass Spectrometry: Basic principles and instrumentation (components and their significance). Ionization techniques, mass spectrum and its characteristics, molecular ion, metastable ions, fragment ions; fragmentation processes, fragmentation patterns and fragment characteristics in relation to parent structure and functional groups. Relative abundances of isotopes and their contribution to characteristic peaks.

UNIT – IV

Chromatographic Techniques: Classification of chromatographic methods based on mechanism of separation and their basic principles. Gas chromatography: Instrumentation, column efficiency parameters, derivatisation methods, applications in pharmaceutical analysis. Liquid chromatography: Comparison of GC and HPLC, instrumentation in HPLC, normal and reversed phase packing materials, column selection, mobile phase selection, efficiency parameters, applications in pharmaceutical analysis. Instrumentation and applications of HPTLC, ion exchange chromatography, gel permeation chromatography, chiral chromatography, flash chromatography, and supercritical fluid chromatography (SFC).

UNIT – V

Electrophoresis: Principles, instrumentation and applications of moving boundary electrophoresis, zone electrophoresis (ZE), isotachphoresis, isoelectric focusing (IEF), continuous electrophoresis (preparative) and capillary electrophoresis. SDS gel electrophoresis and blotting techniques.

Radio immunoassay and ELISA: Principle, instrumentation, applications and limitations.




Recommended books

  1. 1. Skoog, DA, Holler, FJ, Crouch, SR. Principles of instrumental analysis. 6th ed., Baba Barkha Nath printers, Haryana, 2007.

  2. 2. Silverstein, RM, Webstar, FX. Spectrometric identification of organic compounds. 6th ed., John Wiley & Sons (Asia) Pvt. Ltd., Singapore, 2005.

  3. 3. William Kemp. Organic spectroscopy, 3rd ed., Palgrave, New York, 2006.

  4. 4. Jag Mohan, Organic spectroscopy: Principles and Applications, 2nd ed., Narosa publishing house Pvt Ltd., New Delhi, 2005.

  5. 5. Conners KA. A Text book of pharmaceutical analysis, 3rd ed., John Wiley & Sons, Singapore, 2004.

  6. 6. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental methods of analysis, 7th ed., CBS Publishers & Distributors, New Delhi, 1986.

  7. 7. Pavia DL, Lampman GM, Kriz GS, Vyvyan JA. Introduction to spectroscopy. 4th ed., Brookescole publishers, California, 2008.

  8. 8. Sharma BK. Instrumental methods of chemical analysis, 25th Ed., Goel Publishing house, Meerut, 2006.

  9. 9. Beckett, AH, Stenlake, JB. Practical pharmaceutical chemistry, Part I & II, 4th ed., CBS Publishers & distributors, New Delhi, 2004.

  10. 10. Ewing, GW. Instrumental methods of chemical analysis, 5th ed., McGraw Hill Book Company, New York, 1985.

  11. 11. Schirmer, RE. Modem methods of pharmaceutical analysis, Vol. I & II, 2nd ed., CRC Press, Florida, 2000.

  12. 12. Moffat, AC, Osselton, MC, Widdop, B. Clarke's analysis of drugs and poisons, Vol. I & II, 3rd ed., K.M. Varghese Company, Mumbai, 2004.



DRUG DESIGN AND MOLECULAR PHARMACOLOGY

Subject Code : M.PCOL T.1.102 Sessional :30

Periods/Week : 4 Examination : 70

Nature of Exam : Theory Exam Duration : 3 Hrs

UNIT –I

Pharmacokinetics approach to New Drug Discovery

Basic concepts and Defination, importance of ADME parameters in disposition, therapeutics and development their implication on drug discovery.

UNIT-II

Overview on computer aided Drug design (CADD) including QSAR, Combinational Chemistry, High Throughout screening (RTS)

UNIT-III

Molecular Basis of Drugs Action: Cell signaling, communication between cells and their environment, ion-channels, organizations of signal transduction pathways, third messengers, biosensors.

Drug Latentiation :Basic concept, Prodrugs of functional groups, Bio-precurssor prodrugs, chemical delivery system.

UNIT – IV

Biotechnology in Drug Discovery: Cloning of DNA, Expression of cloned DNA, Manipulation of DNA sequence information, New Biological Targets for Drug Development Novel Drug Screening strategies, Novel Biological Agents, Antibodies, Antisense eligonucleotide therapy, Gene therapy.

UNIT – V

Herbal Neutracauticals as new source for medicines.

Study of Advanced drugs from natural sources of following groups:

Anticancer, Anti AIDS, Hepatoprotectives, Antidiabetics, Brain Toni cs, Anti urolithiates, Antifilarial, Antihyperlipidimics.

Modern phytochemical screening techniques and evaluation of herbal drugs and

their extracts and formulations, Concept of Reverse Pharmacognosy.

Books recommended



  1. 1. Comprehensive Medicinal chemistry Vol-4 Ed.C. Hanseh, Pergamon Press, New York.

  2. 2. Comprehensive Biotechnology, Ed. Murray Moo-Young, Pergamon Press, New York.

  3. 3. Comprehensive Biotechnology information publications (www./nobi.nml.nih.gov )

  4. 4. Dewick Paul M. Medicinal Natural Products-A Biosynthetic Approach.

  5. 5. Chakravarty T.K. “ Herbal Options”.



BIOASSAYS AND SCREENING METHODS

Subject Code : M.P COL T.1.103 Sessional : 30

Periods/Week : 4 Examination : 70

Nature of Exam : Theory Exam Duration: 3 Hrs

UNIT –I

Drug discovery process: Principles techniques and statergies used in new drug discovery. High throughout screening. Human genomies robotics and economics of drug discovery, Regulations, for laboratory animal care and ethical requirements.

Bioassays : Basic principles of bioassays official bioassays, experimental models and statistical designs employed in biological standardization. Biological standardization of vaccines and sera with certain examples with reference to IP. Development of new bio assay methods.

UNIT – II

Preclinical models employed in the screening of new drugs belonging to following categories.

Antifertility agents, sympathomimetics, parasympathomimetics, muscle relaxants (both central and peripheral). Sedatives, hypnotics, antiarrhythmic agents, cardiac stimulants, cardiotonic agents bronohodilators, antihistaminics, eicosanoids.

Antipsychotic agents, antianxiety agents nootropic drugs antidepressant drugs; antiparkinsonism agents, anticpileptics; analgesics and anti-inflammatory agents; antiulcer agents; infarction; antiatherosclerotic drugs; antidiabetics; models for status epilepticus drugs. cerebroventricular and other newer techniques of drug administration and development; transgenic animals and other genetically prone animal models.

UNIT – III

Alternatives to animal screening procedures, cell-line handling and maintenance and propagation of cell lines, patch-clamp technique, in-vitro cell line based assays diabetics and arthraitis models, molecular biology techniques.

UNIT – IV

Principles of toxicity evaluations, ED50, LD50 and TD values, International guidelines (ICH Ethics and animal experimentation recommendations).Guidelines and regulatory agencies – CPCSEA,OECD,FDA, FHSA,EPA,EEC,WHO etc,

UNIT – V

Introduction to biostatistics, parametric and non-parametric tests. Regression and correlation: Linear regressions, Method of least squares; correlation coefficients, rank correlation, multiple regression Tests of significance: testing hypotheses, tests of significance based on normal distribution. t-test; significance of correlation coefficient. F-test and Analysis of Variance: 1-Way, 2-Way and 3-way classification, Chi-square test of (i) Variance of a normal population (ii) Goodness of fit, (iii) Independence in contingency tables. Non parametric tests, order statistics, sign test, run test, Median test.


Books recommended



  1. 1. Pre – Clinical Drug Development , Rogge

  2. 2. Basic and clinical Pharmacology, Katzung

  3. 3. Pharmacological screening methods, N.S. Parmer and Shivkumar

  4. 4. Pharmacological screening methods, N.S. Parmer and Shivkumar

  5. 5. Calculations for Pharmaceutical Practice , Winfield

  6. 6. Pharmacoepidemiology , Storm

  7. 7. CPCSEA, OECD, FDA, WHO, ICH guidelines from respective website downloads.

  8. 8. Drug discovery and pharmacological evaluations, G.Vogel, Springer publications.



BASIC PRINCIPLES OF TOXICOLOGY

Subject Code : M.PCOL T.1.104 Sessional : 30

Periods/Week : 4 Examination : 70

Nature of Exam : Theory Exam Duration : 3 Hrs

Unit – I

General principal of regulatory toxicology. Use of animals in preclinical toxicology studies, role of preclinical toxicology in drug discovery and development process. Experimental considerations for assessing possible human risk. Flow chart for development of preclinical testing. Dose conversion factors, clinical signs toxicity.

Unit – II

Single dose and repeat dose toxicity studies; Factors influencing such studies such as species, sex, size, route ,dose level; Data evaluation and regulatory requirements. Determination of Maximum Tolerated Dose (MTD) and LD 50 as per revised OECD guidelines. Allergenicity testing, dermal toxicity, immunotoxicology and in vitro methods of toxicology.

Unit – III

Reproductive toxicology assessment of male reproductive toxicity, spermatogenesis; Risk assessment in male reproductive toxicity; Female reproductive toxicology; Oocyte toxicity; alterations in reproductive endocrinology; Relationship between maternal and developmental toxicity.

Unit – IV

Mutagenicity; Mechanisms of mutagenesis, point mutations,; Individual chromosomes and complete genome mutations, germ cell mutations, somatic cell mutation; Tests systems in vitro, chromosome damage and chromosomal aberration test, gene mutation, in vivo micronucleus tests in rodents, metaphase analysis.

Unit – V

Preclinical toxicological requirements for biologicals and biotechnological products; safety analysis; problems specific to recombinant products, toxicokinetics, principles of GLP as per OECD guidelines for conducting preclinical toxicity studies

Books recommened



  1. 1. Drug safety Evaluation, Shayne C Gad, Wiley Interscience

  2. 2. The toxicologist’s pocket handbook, Michael J derelanko 2nd Ed,2008,CRC press

  3. 3. Relevent OECD guidelines ( Internet resources)

http://www.ingentaconnect.com /content/oecd/16073/2001/00000001/00000004


PHARMACEUTICAL ANALYTICAL TECHNIQUES (PRACTICAL)

Subject Code : M.PCOL.P.1.105 Sessional : 30

Period / Week: 6 Examination : 70

Nature of Exam: Practical Exam Duration : 6 Hrs

List of Experiments

  1. 1. UV/Visible spectrum scanning of a few organic compounds for UV- absorption and correlations of structures (5 compounds) and isosbestic point in case of mixtures.

  2. 2. Effect of solvents and pH on UV spectrum of drugs (2 experiments).

  3. 3. Estimation of multicomponent formulation by UV- Spectrophotometer in formulations. (2 experiments).

  4. 4. Experiments based on the application of derivative spectroscopy. (2 experiments).

  5. 5. Experiments based on HPLC (Isocratic and Gradient elution) techniques.


(2 experiments).

  1. 6. Interpretation of drugs by IR spectra.

  2. 7. Workshop of spectroscopy: (UV, IR, NMR, MASS) structural elucidation of at least 5 compounds (4 experiments).

  3. 8. Separation of protein drug substances by electrophoresis.

  4. 9. Any other relevant experiments based on theory.






BIOASSAYS AND SCREENING METHODS

Subject Code : M.PCOL P 1.106 Sessional : 30

Periods/week : 6 Examination : 70

Nature of Exam: Practicals Exam Duration: 6 Hrs

List of Experiments

.

  1. 1. Biological standardization of drugs like acetylcholine/Histamine

  2. 2. Experiments on CNS. General screening methods of drugs on CNS

CNS stimulants and depressants, anxiogenics and anxiolytics, amnestics

and nootropics, anti convulsants, analgesics, safety pharmacology.

3. Drugs acting on Gastrointestinal tract

General screening methods for the anti ulcer activity, intestinal motility, and anti-diarrhoeals.

4. Experiments on CVS


General screening procedure of anti-arrhythmic agents, anti-hypertensives, anti-ischemics.

  1. 5. Experiments on Local anesthetics

General methods for evaluating local anesthetic activity

6. Experiments on General Pharmacology

Enzyme induction activity, drug dependence and withdrawl effects.

7. Experiments on Diueretics

General screening methods for evaluating the diuretic activity.

8. Screening procedure for antidiabetic drugs.

9. Experiments on analgesic and anti-inflammatory agents

General methods of screening for the evaluation of analgesics and

anti inflammatory agents, [both acute and chronic models]

10. General methods for evaluating the antimicrobial activities of chemotherapeutic agents.

11. Estimation of biochemical and free radical scavengers.


Recommended books



  1. 1. Hand book of Experimental Pharmacology S.K.Kulkarni

  2. 2. Hand book of laboratory animal science, Animal models, Jann Hau, 2nd edition vol 2, 2002.

  3. 3. Hand book of Laboratory Animal Science: Selection and Handling of Animals in Biomedical research: v 1, Per Svendsen, Jann Hau, 1994



SCIENTIFIC AND TECHNICAL WRITING

Subject Code : M.PCOL T 1.107 Sessional : 50

Periods/week : 2 Examination : --

Nature of Exam : Tutorials Exam Duration: --

Course Objectives

To be able to appreciate and understand importance of writing scientifically.

  1. • To Develop competence in writing and abstracting skills.

  2. • To write either a draft research proposal or a chapter of dissertation.


UNIT – I

COLLECTION AND EVALUATION OF INFORMATION

Identification sources, searching information, classifying information under fact/opinion, tabulating information, summarizing a text and presenting sequence of topics in different forms.

UNIT – II

WRITING AS A MEANS OF COMMUNICATION

- Different forms of scientific and technical writing.

- Articles in journals, Research notes and reports, Review articles, Monographs,

Dissertations, Bibliographies.

How to formulate outlines: The reasons for preparing outlines

  1. (i) as a guide for plan of writing (ii) as skeleton for the manuscript


Kinds of outline: topic outlines, conceptual outline, sentence outlines and combination of topic and sentence outlines

UNIT – III

DRAFTING TITLES, SUB TITLES, TABLES, ILLUSTRATIONS

- Tables as systematic means of presenting data in rows and columns and lucid way of indicating relationships and results.

- Formatting Tables: Title, Body stab, Stab Column, Column Head, Spanner Head, Box Head

- Appendices: use and guidelines

The Writing process: Getting started, Use outline as a starting device, Drafting, Reflecting and Re-reading

Checking: Organization, Headings, Content, Clarity and Grammar

Brevity and Precision in writing - Drafting and Re-drafting based on critical evaluation

UNIT – IV

  1   2

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