Benefit–risk assessment

As an very important aspect of the clinical evaluation of a phase-I trails is to administration of new drug then check the QT/QTc interval to determine the risk of cardiac repolarization Prolongation based on International Conference on Harmonization (ICH) E14 guidelines. To justify the safety of the patient is checking by the Electrocardiogram (ECG) parameters including PR and RR intervals, QTc Duration, QRS duration, T wave morphology, presence of U waves, and Outlier assessment. Hypothesis is Administration of a single dose of drug does not prolong the QTc interval to a clinically significant degree. Primary assessment of the true mean difference (drug-placebo) of QTc change from baseline is less than 10msec. We can estimate this Primary assessment by using more flexible and advance method proc mixed procedure. To identify a dose of the preliminary market formulation (PMF) of new drug that can achieve a safe and well tolerated maximum plasma concentration (Cmax) at least 5X higher than the Cmax associated with the clinical dose of new drug that can be known and justified by statistical assessment using Proc Mixed Procedure. Based upon this procedure we can estimate very import statistics like sample calculation, LS-means, CI, F-stats, Probability, chi-square etc. which can be justify the safe and tolerated of new drug.