BIOSTATISTICS AND RESEARCH METHODOLOGY PHARMCY SUBJECTS,THEIR TOPICS AND TEXT BOOKS AND REFERANCE BOOKS
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BIOSTATISTICS AND RESEARCH METHODOLOGY
1 Research Methodology
a) Types of clinical study designs:
Case studies, observational studies, interventional studies,
b) Designing the methodology
c) Sample size determination and Power of a study
Determination of sample size for simple comparative experiments, determination of sample size to obtain a confidence interval of specified width, power of a study
d) Report writing and presentation of data
b) Types of data distribution
c) Measures describing the central tendency distributions- average, median, mode
d) Measurement of the spread of data-range, variation of mean, standard deviation, variance, coefficient of variation, standard error of mean.
Construction and labeling of graphs, histogram, piecharts, scatter plots, semilogarthimic plots
2.3 Basics of testing hypothesis
a) Null hypothesis, level of significance, power of test, P value, statistical estimation of
b) Level of significance (Parametric data)- students t test (paired and unpaired), chi Square test, Analysis of Variance (one-way and two-way)
c) Level of significance (Non-parametric data)- Sign test, Wilcoxan’s signed rank test,
Wilcoxan rank sum test, Mann Whitney U test, Kruskal-Wall is test (one way ANOVA)
d) Linear regression and correlation- Introduction, Pearsonn’s and Spearmann’s correlation and correlation co-efficient.
e) Introduction to statistical software: SPSS, Epi Info, SAS.
Statistical methods in epidemiology
Incidence and prevalence, relative risk, attributable risk
3. Computer applications in pharmacy
Computer System in Hospital Pharmacy: Patterns of Computer use in Hospital Pharmacy –
Patient record database management, Medication order entry – Drug labels and list – Intravenous
solution and admixture, patient medication profiles, Inventory control, Management report & Statistics.
Computer In Community Pharmacy
Computerizing the Prescription Dispensing process
Use of Computers for Pharmaceutical Care in community pharmacy
Accounting and General ledger system
Drug Information Retrieval & Storage :
Introduction – Advantages of Computerized Literature Retrieval
Use of Computerized Retrieval
a. Pharmaceutical statistics- practical and clinical applications, Sanford Bolton 3rd edition, publisher Marcel Dekker Inc. NewYork.
b. Drug Information- A Guide for Pharmacists, Patrick M Malone, Karen L Kier, John E Stanovich , 3rd edition, McGraw Hill Publications 2006
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What is 510(k) Clearances,
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Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
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New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
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