Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-09-21 23:22 CEST (UTC+2h)
 
paulhurleyuk
Junior

NE UK,
2017-01-26 11:04

Posting: # 16995
Views: 1,069
 

 Students given 30g dose of Caffeine in Sports study [Off Topic]

Local to me, this story about a study in a sports science course of the effect of caffeine on exercise;

http://metro.co.uk/2017/01/25/students-left-fighting-for-life-after-taking-enough-caffeine-for-300-cups-of-coffee-6405671/

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 ?

Paul.
Dr_Dan
Senior

2017-01-31 08:42

@ paulhurleyuk
Posting: # 16999
Views: 703
 

 Clinical trial? According to ICH-GCP definition yes!

» Out of interest, Caffeine is released and available, so this isn't a clinical trial, but what regulations do apply ?

Dear Paul
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
Dr_Dan
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,319 Posts in 3,704 Threads, 1,069 registered users;
27 users online (0 registered, 27 guests).

The statistician has no magic touch by which
he may come in at the stage of tabulation
and make something of nothing.    W. Edwards Deming

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed