The rule provides a framework for potential licensure of medical products when definitive efficacy studies that would involve
exposing healthy human volunteers are unethical and field trials after accidental human exposure are not feasible.
The molecule was produced by Portuguese drugmaker Bial and tested
in healthy human volunteers in a phase I study by the French contract research company Biotrial in Rennes.
The team tested its patch on both pig skin (which is an excellent model for the human skin barrier) and
on healthy human volunteers and found that it could accurately monitor glucose levels across the hypo - to hyper - glycaemic range in diabetic patients over six hours.
Broccoli sprout extract protects against oral cancer in mice and proved tolerable in a small group
of healthy human volunteers, the University of Pittsburgh Cancer Institute (UPCI), partner with UPMC CancerCenter, announced today at the American Association for Cancer Research (AACR) Annual Meeting in Philadelphia.
To measure reproducibility, one study published recently in the World Journal of Gastroenterology analyzed 70 blood samples from 18
healthy human volunteers at intervals of zero, six, 24, and 30 hours (18).
Studies performed
with healthy human volunteers showed that alpha - casozepine can be used to prevent the physiological effects of acute or chronic stress in people.
Lactobacillus helveticus and Bifidobacterium longum:
Healthy human volunteers who consumed a probiotic mix of these bacteria exhibited less anxiety and depression.
According to Tomas Cihlar, Ph.D., of Gilead Sciences, the company is currently conducting phase I clinical studies of the compound
in healthy human volunteers to establish the safety and pharmacokinetic profile.
In this study the team tested the patch on both pig skin, where they showed it could accurately track glucose levels across the range seen in diabetic human patients, and
on healthy human volunteers, where again the patch was able to track blood sugar variations throughout the day.
Over 14 days, 40
healthy human volunteers (8 per dose group) received up to 16 mg per kilogram of body weight per day, representing the highest continuous dosing of an antisense agent.
This pilot study involved six
healthy human volunteers, who took 200 mg once a day for 15 days.
A recent (November 2016) meta - analysis of seven studies with around 300 participants showed that supplementation with probiotics resulted in a significant improvement in psychological symptoms of depression, anxiety, and perceived stress in
healthy human volunteers (16).
But Segal's team went further, testing the association directly in a small group of lean and
healthy human volunteers who normally eschewed artificial sweeteners.