Flashcards
Licensing a new drug
Cards in this deck (20)
- 1What is a placebo?An inert substance which doesn't contain the chemical being tested
- 2A paper is published describing a patient who was diagnosed with a rare condition. What type of study is this?A case study
- 3A paper is published which looks at the number of complications of a disease within patients with that disease, at a single point in time. What type of study is this?A cross sectional study
- 4A study is conducted looking at the benefit of an old drug in the treatment of a specific condition over a long period of time. What type of study is this?A cohort study
- 5A study is conducted looking at the benefit of a new drug compared with an old one to treat a specific condition. What type of study is this?A randomized clinical trial
- 6What is a randomised double-blind controlled trial?Neither the patients nor the doctors know who is getting a placebo
- 7What is tested in phase 1 trials?A test dose of the drug in a few healthy volunteers
- 8What is tested in Phase 2 trials?An established dose of the drug in a few patients with the condition
- 9What is tested in Phase 3 trials?A therapeutic dose of the drug in a large number of patients with the condition
- 10What is examined in phase 4 trials?Long- term side effects after the drug was marketed
- 11What do clinical trials help determine?The safety and efficacy of the new drug or treatment
- 12What are the titles for the key modules submitted as part of the CTD?- Quality
- Non-clinical study reports
- Clinical study reports - 13Why should a power calculation be done in planning a phase 3 clinical trial?To ensure that the outcomes are statistically valid
- 14Prior to market authorisation of a new drug, which document is submitted to the regulatory authorities?The Common Technical Document
- 15What is the purpose of phase 1 clinical trials?To explore the safety of a new drug
- 16What is the purpose of Phase 2 clinical trials?To explore and confirm the efficacy and safety of a new drug
- 17What is the purpose of Phase 3 clinical trials?To confirm the safety and efficacy of a new drug
- 18What are Phase 4 trials also known as?Post-marketing surveillance
- 19What is the purpose of the yellow card scheme?To allow the MHRA to monitor the safety of medicines that are on the market
- 20Name 2 types of hypersensitivity toxicological studiesGuinea pig maximization test
Local lymph node assay