Lippincott Illustrated Review in Pharmacology 4

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4 Lippincott Illustrated Review in Pharmacology 4 C.C. Chatterjee: Human Physiology, Vol. I & II, Medical Allied Agency & Hall: Text book of Medical Physiology, Saunders Bhattacharya et. al: Pharmacology, 2 Tripathi: Essentials of Medical Pharmacology, Jaypee brothers Crossland : Lewis Pharmacology, Churchill Living stone

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8 operon, regulation of bacteriophage λ life cycle. Vectors and cloning

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11 Ratkowsky et al. : Cross Over Experiments: Design, Analysis & Applications,

12 Rhematoid arthritis, Osteoarthritis, gout, Paget s diseases of Bone.

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14 Schedule γ, NDA, ANDA.

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17 Investigator s Responsibilities, Vulnerable populatio

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19 Clean data check list etc

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22 2. Barton L. Cobert & Pierre Biron, Blackwell Science 3. Good Pharmacovigilance Practice MHRA 4. Manual of Drug Safety and Pharmacovigilance Barton L. Cobert, Jones & Bartlett Publishers 5. Dictionary of Pharmacovigilance Amer Alghabban, Pahrmaceutical Press 8. Barton L. Cobert & Pierre Biron, Blackwell Science 9. Good Pharmacovigilance Practice MHRA 10. Manual of Drug Safety and Pharmacovigilance Barton L. Cobert, Jones & Bartlett Publishers 11. Dictionary of Pharmacovigilance Amer Alghabban, Pahrmaceutical Press

23 1. Introduction to Epidemiology, Purpose & Application, History of Epidemiology 1h 2. Fundamentals of Epidemiology: Concepts of the epidemiological approach, Study design. Calculation and interpretation of measures of frequency, association, and public health impact, Sources of study error including the influence of chance, bias, confounding, and effect modification, Basic concepts of standardizing rates, surveillance, and screening 4h 3. Introduction to Public Health Surveillance: Basic principles of public health surveillance, including the establishment of a public health surveillance program, the collation and analysis of data, and the preparation and distribution of a report, Importance of a direct association between a public health surveillance program and public health action, Public health surveillance systems conducted in developed, as well as developing countries, Public health surveillance programs as applied to all public health problems involving either infectious or noninfectious diseases 5h 4. Epidemiologic Methods I: Concepts and premises of the science of epidemiology. Methods of hypothesis formulation and evaluation, Techniques for quantifying the amount of disease (or other health indicator) in populations, Epidemiologic study designs useful for identifying etiologic factors and other relevant correlates of disease, Calculation of basic epidemiologic measures of frequency, association, and impact, Concepts of random variability, bias, and effect modification, Use of stratified analysis, including Mantel-Haenszel techniques 5h 5. Epidemiologic Methods II: Statistical foundations of epidemiological methods, Concepts of matching, confounding, effect modification and interaction, Modeling techniques for epidemiological data analysis including logistic regression for matched and unmatched studies 5h 6. Hospital/Healthcare Epidemiology: Investigation, control, and prevention of hospital acquired infectious diseases and other hospital events by the use of appropriate epidemiologic techniques, both descriptive and analytic 4h 7. Epidemiology of Food borne and Diarrheal Diseases: Basic epidemiology of infectious food borne and diarrheal diseases of India, United States and the world, Study of these diseases and outbreak investigations to develop broadly applicable epidemiologic skills, Dynamic relationship between changing global environment and human health distribution, changes in the human population 5h 8. Epidemiology & Infectious diseases: 5h

24 b. HIV Epidemiology: c. Epidemiology and Dynamics of STD and HIV Transmission: Social, biologic, and public health issues of sexually transmitted diseases (major STDs) and their overall importance in public health, implication of transmission models for prevention, and psychosocial, behavioral, and economic aspects of STD/HIV. 9. Human Genome Epidemiology: Applications of epidemiologic methods and approaches to evaluating the use of human genetic discoveries in the practice of medicine and public health in the 21st century, Assess the prevalence of genetic variation in the population, Characterize the burden of disease associated with genetic variation and with gene- environment interaction, Evaluate the impact of genetic tests in reducing morbidity and mortality. 5h 10. Pharmacoepidemiology: Application of epidemiologic methods to study uses and effects of pharmaceutical products in human populations, Identification and quantification of new adverse events and risk factor s, Studies of disease natural history necessary to understand drug effects and studies of drug utilization, Use and design of Risk Evaluation and Management (REMS) programs to mitigate known risks; identification of new risks for marketed products, including both active and passive surveillance programs, and the application of data mining; databases and study designs used in pharmacoepidemiology; the decision-making process in pharmacoepidemiology using contemporary examples; and new and emerging developments in the field, including the application of meta-analysis to answer safety questions, the safety gap and pharmacogenomics 5h Practical issues in Epidemiological Studies: i). Analysis and interpretation of epidemiological data Preparation of survey data for statistical analysis Development of a data coding schedule, Development of a computer database, Procedure for data entry, Checking for errors in entered data, Missing data, Recoding of entered data, Storage of data and data set, Introductory data analysis: descriptive epidemiology - Incidence rates,prevalence (proportions), Crude, age-specific and standardised rates Introductory data analysis: analytical epidemiology - Effect measurement, interval assessment and significance testing, Analysis of case-control studies, Analysis of cohort studies Confounding - Minimising confounding in study design Bias - Major sources of bias, type of bias Ethical issues in epidemiology Ethical approvals, consent, confidentiality and data protection, detection of previously unrecognized disease, Economics of epidemiological studies Cost vs Design

25 Costing Resource management Books: 1. Gordis, L. Epidemiology. Elsevier-Saunders, Philadelphia, 4th Ed., Posta, Miquel (Ed): Dictionary of Epidemiology, Oxford University Press, New York, 5th Ed., Epidemiology for public health practice Robert Friis, Jones & Bartlett Publishers 4. Essentials of Epidemiology in Public Health Ann Aschengrau & George R. Seage, Jones Bartlett Publishers 5. Handbook of Epidemiology - Ahrens, Wolfgang; Pigeot, Iris (Eds.), Springer 6. Principles of Epidemiology in Public Health Practices: An introduction to Applied Epidemiology & Biostatistics US Dept of Health & Human Services, CDC. 7. Epidemiology for the Uninitiated Coggon, Rose & Barker, BMJ Publishers, Epidemiology For Public Health Practice - Friis Robert H ; Publisher- Jones and Ba 9. Epidemiology In Medical Practice - Barker D J P ; Publisher: Churchill 10. Foundations Of Epidemiology - Lilienfield David E; Publisher: Oxford Uni 11. Applied Longitudinal Data Analysis For Epidemiology: A Practical Guide - Twisk Jos W R, Cambridge Publ. 12. Medical Epidemiology Greenberg Raymond S.; Publ Lange 13.Primer of Epidemiology Friedman Gary D.; Publ _ McGraw Hill 14. An Integrated Introduction To The Ideas, Theories, Principles And Methods Of Epidemiology - Bhopal Raj S; Publisher: Oxford Uni

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27 Difference between Descriptive and Inferential Statistics; Relationship t test Z test nova: F test

28 some statistical aspects of quality and the Barr Decision.

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30 Goodman and Gilman s The Pharmacological basis of Thera