Posting: # 16995
Local to me, this story about a study in a sports science course of the effect of caffeine on exercise;
From the story; this trial had been conducted as part of the teaching course for many years, but had switched from tablets to caffeine powder. For this trial a member of staff calculated dosage using a mobile phone instead of a calculator, and the decimal place was misplaced, hence a dose of 30g, not 0.3g ! (Check out the pictures in the article comparing these two doses...)
Out of interest, Caffeine is released and available, so this isn't a clinical trial, but what regulations do apply ?
Posting: # 16999
» Out of interest, Caffeine is released and available, so this isn't a clinical trial, but what regulations do apply ?
According to ICH-GCP a clinical trial is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining ist safety and/or efficacy.
IMHO the students were treated with a drug (coffeine as pure drug and not as cup of coffee) and nobody thought about the consequences neither for the students nor for themselves.
Kind regards and have a nice day