Clarity about the basic fundamental of biostatistics like- types of data, measures of central tendency, measures of dispersion, p-value, hypothesis testing, confidence interval, types of error, the importance of degrees of freedom ? Knowledge about the use of Sample size methods according to study design like superiority, Equivalence, Non-inferiority ? Hands-on practice of generation of Randomization schedule using SAS programming for parallel design & crossover design ? Hands-on calculation for various parametric & non-parametric bio-statistical tests like t-test, ANOVA, ANCOVA, RMANOVA, Linear Regression, Chi-square, F-test, Sign test using SAS programs ? Good knowledge about Conclusion & interpretation of statistical outcomes derived from various statistical methods ? Detail knowledge about Bioavailability & Bioequivalence studies: Crossover study design, definitions and calculation of Pharmacokinetic parameters, washout period, carryover effect, intra-subject CV, 90% two-one-sided confidence interval, Bioequivalence limits, Power of the study ? Project done on 2x2 crossover BE study ? Knowledge of various designs of Clinical trials, applications of various statistical methods according to data, study objective, primary-secondary efficacy and safety parameters ? Basic knowledge of the importance of SOP & Guidelines