ANALYSIS OF PULSE RATE VARIABILITY DURING BIOEQUIVALENCE STUDIES IN HEALTHY VOLUNTEERS.

Abstract

OBJECTIVE: The objective of this study was to evaluate the impact of bioequivalence studies on vital organs and their working ability during the procedure.

PLACE AND DURATION: Pharma Professional Services, Karachi, October 2018 to September 2019.

METHODOLOGY: A group of 93 volunteers were tested for pulse rate up to 12 hours during BE studies. All the data contained were from 4 BE studies carried out at volunteers of Sindh, Pakistan. As per standard protocols on different times before drug administration and after 1, 2, 4, 8 and 12 hours of drug administered, all this data was collected for pulse rate of volunteers. All these studies were containing same procedures such as 3 hours fasting and then meals as per schedule. This study is always carried out to check the physical status of volunteer’s. All the data which were gathered were analyzed using SPSS 22.0 version. The tests which were performed to evaluate this data was analysis of variance (ANOVA).

RESULTS: The normal ranges of the pulse rate were selected and then it was observed from the results that all of these volunteers remained stable and their pulse rate were in normal range. CONCLUSION: From the above results of study it is concluded that healthy volunteers of BE studies during the process of BE studies have normal autonomic condition which in turn gives the normal pulse rate.