Regulation Of Medicines Flashcards
How many patients are involved in a stage 1 clinical trial?
20-80
What is the purpose of a stage 1 clinical trial?
To determine dosage range, evaluate safety and identify side effects
How many patients are involved in a stage 2 clinical trial?
100-300
True or false, 1000-3000 patients take part in a phase 3 clinical trial?
True
What is the purpose of a stage 3 clinical trial?
Confirm efficacy, monitor side effects and compare to commonly used treatments
True or false, at stage 4 of a clinical trial, the drug has marketing authorisation?
True
What is covered by the regulation of medicine legislation?
Investigational medicinal products, medicinal products, authorised medicinal products, relevant medicinal products and borderline substances
Define an authorised medicinal product
Has marketing authorisation (medicines), traditional herbal registration or a certificate of registration (homeopathics)
True or false, a relevant medicinal product is one with a marketing authorisation so can only be a medicine?
True
Give two examples of borderline substances?
Cosmetics and food supplements
Which legislation covers medical devices?
Medical devices regulations 2002
True or false, the CE mark is mandatory on all medical devices and is equivalent to their marketing authorisation?
True
