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paulhurleyuk ☆ NE UK, 2017-01-26 12:04 (2640 d 07:46 ago) Posting: # 16995 Views: 4,674 |
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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. |
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Dr_Dan ★★ Germany, 2017-01-31 09:42 (2635 d 10:07 ago) @ paulhurleyuk Posting: # 16999 Views: 3,581 |
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❝ 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 |
Ing. Helmut Schütz