BME100 f2017:Group14 W0800 L3

TEAM MEMBERS

Name: Shae Diaz

Name: Kennedy Miskin

Name: David Asuncion

Name: Sean Smits

Name: Carlos Mendez-Arias

Design for Our Experiment

Gold Standards:

·Oral medication of Lorazepam

·IV Lorazepam

·Rectal Diazapam

Target sample size: 660, arrived at this number by calculating the current amount of people with epilepsy in the US (3 million) and the confidence level (5%)

To test how fast medication is getting into bloodstream:

1. Compare oral dosage of Lorazepam, IV injection of Lorazepam, rectal Diazepam, and our auto injector (LorazePen)

2. Obtain sample size (approximately 660 people)

·500 people to be divided into three groups: one receiving IV, rectal, and auto injector (these people are epileptics, ranging from focal to generalized)

·160 people will receive the oral dosage (these people are not actively seizing, rather they have been prescribed it for anxiety)

3. Set time intervals for which we will take blood samples to measure the concentration of medication inside the bloodstream

·Intervals (min): 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 120, 240, 360, 480

·20 total blood draws

·Maximum amount of blood to draw per person: about 3% of their total blood volume

·On average, people have 5 liters³ of blood so the average of blood allowed to draw is .15 liters¹