BP707T

Regulatory Affairs (Theory)

Unit-wise topics with PDF download buttons

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UNIT 1

Basic concepts of biostatistics 1. Definition, meaning and type of variables Data – Meaning and methods of data collection, data preprocessing and cleaning Population and sample, Importance of sampling, Sampling methods Probability and non-probability sampling o Probability sampling - Random, systematic, stratified, cluster sampling o Non-probability sampling - Convenience sampling, purposive sampling, snowball sampling Types of statistics - Descriptive statistics and inferential statistics Descriptive statistics – Meaning and types of descriptive statistics Frequency distribution, measures of central tendency Measures of dispersion – Range, variance and standard deviation. Concept of degrees of freedom, quartiles, skewness and kurtosis Diagrammatic representation of frequency distribution

UNIT 2

Probability and probability distributions 1. Probability and probability distributions- Classical probability and statistical probability Probability of union, intersection and complement of events, conditional probability, marginal probability 2. Probability distributions- Meaning of a probability distribution Discrete probability distribution- Meaning and examples of discrete probability distribution, meaning of PMF Continuous probability distribution – Meaning and examples of normally distributed data, meaning of PDF t distribution – the t statistic, equation for calculating t statistic, meaning of t distribution, meaning of degrees of freedom and their relevance to t distribution, reading and interpreting table of t values, applications of t distribution F distribution – the F statistic, equation for calculating F statistic, meaning of F distribution, reading and interpreting table of F values Chi square distribution – the Chi square statistic, meaning of chi square distribution, reading and interpreting the table of chi square values, applications of chi square distribution. B.Pharm Syllabus

Normal distribution – Meaning and characteristics of a normal distribution, parameters of a normal distribution, equation for PDF of a normal distribution. Pharmaceutical examples of data which can be modelled with Poisson Normal distribution. Download PDF

Standard normal distribution, Z transformation, reading the table of Z values Problems based on standard normal distribution, binomial and Poisson distributions 3. Sampling distributions – Meaning of sampling distributions Download PDF

UNIT 3

Correlation and regression analysis 1. Correlation analysis – Introduction to the concept of correlation between two variables, positive and negative correlation, no correlation, examples of positive, negative and no correlation Measurement of correlation - Pearson’s Correlation Co-efficient – Definition and formula, assumptions, range of Pearson’s correlation co-efficient, interpretation of sign and magnitude Spearman’s Rank Correlation Co- efficient – Concept and when to use, procedure for calculation Spearman’s Rank Correlation Co- efficient. Real life applications in pharmaceutical and health sciences Problems on calculation of these two types of correlation co-efficient, use of scatter plot Multiple correlation – Concept and applications. 2. Regression analysis – Concept of regression, dependent and independent variables in regression analysis, simple linear regression, simple linear regression equation (method of least squares), calculation of slope and intercept, co-efficient of determination, interpretation of output of regression analysis, applications of regression analysis. Relationship between regression co-efficient and correlation co-efficient Problems on simple linear regression analysis for predicting values of dependent variables (pharmaceutical examples) Multiple linear regression-Concept and applications, meaning of overfitting and underfitting.

UNIT 4

Inferential statistics 1. Statistical estimation – Point estimates and interval estimates of population parameters from sample statistics Concept of confidence intervals. Confidence intervals for means using t values. Problems on generating confidence intervals 2. Hypothesis testing – Concept, steps involved, type I and type II error, sample size and power of the test, p values, applications of hypothesis testing Parametric tests - t- tests (single sample t test, two independent samples t test, paired t test) ANOVA (one way and two way). Assumptions, procedure and applications (case studies using t tests and ANOVA) Hypothesis testing in regression analysis and correlation Non-parametric tests - Mann Whitney U test, Wilcoxon Sign Rank test, Kruskal Wallis test, Friedman test, Chi square tests. Assumptions, procedure and applications (problems on non-parametric tests)

UNIT 5

Research methodology Research – Meaning, importance and types. Types of research designs Research methodology – Based on the research question, selection of research design, defining the population and sample, selecting the sample size and sampling method, method of data collection and data analysis. Decision tree approach for selection of statistical tests on the basis of research question and type of data Descriptive research design – Examples of application Observational research design – Examples of application Experimental research design – Examples of application Scientific report writing, plagiarism, referencing styles, selection of research journals, abstracting services and databases Screening and Optimization – Concept and experimental designs used for screening and optimization including Plackett Burman design, factorial designs, D optimal design, sequential simplex design, central composite design and response surface methodology, blocking and confounding in experimental designs.