‘Biostatistics and Research Methodology – Theory’ is a course offered in the fourth year of Pharm. D. program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 2 Hrs./Week

1. Research Methodology
   1. Types of clinical study designs:
      Case studies, observational studies, interventional studies,
   2. Designing the methodology
   3. 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
   4. Report writing and presentation of data
2. Biostatistics
   1. Introduction
      Types of data distribution
   2. Measures describing the central tendency distributions- average, median, mode
   3. Measurement of the spread of data-range, variation of mean, standard deviation, variance, coef- ficient of variation, standard error of mean.
3. Data graphicsConstruction and labeling of graphs, histogram, piecharts, scatter plots, semilogarthimic plots
4. Basics of testing hypothesis
   1. Null hypothesis, level of significance, power of test, P value, statistical estimation of confidence intervals.
   2. Level of significance (Parametric data)- students t test (paired and unpaired), chi Square test, Analysis of Variance (one-way and two-way)
   3. 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)
   4. Linear regression and correlation- Introduction, Pearsonn’s and Spearmann’s correlation and cor- relation co-efficient.
   5. Introduction to statistical software: SPSS, Epi Info, SAS.
5. Statistical methods in epidemiologyIncidence and prevalence, relative risk, attributable risk
6. Computer applications in pharmacyComputer 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 admix- ture, 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

Reference books:

1. Pharmaceutical statistics- practical and clinical applications, Sanford Bolton 3rd edition, publisher Marcel Dekker Inc. NewYork.
2. Drug Information- A Guide for Pharmacists, Patrick M Malone, Karen L Kier, John E Stanovich, 3rd edition, McGraw Hill Publications 2006