18094274
Description
Flashcards by Simeon Crane, updated more than 1 year ago
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Created by Simeon Crane
over 6 years ago
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| Question | Answer |
| What is a placebo? | An inert substance which doesn't contain the chemical being tested |
| A paper is published describing a patient who was diagnosed with a rare condition. What type of study is this? | A case study |
| A 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 |
| A 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 |
| A 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 |
| What is a randomised double-blind controlled trial? | Neither the patients nor the doctors know who is getting a placebo |
| What is tested in phase 1 trials? | A test dose of the drug in a few healthy volunteers |
| What is tested in Phase 2 trials? | An established dose of the drug in a few patients with the condition |
| What is tested in Phase 3 trials? | A therapeutic dose of the drug in a large number of patients with the condition |
| What is examined in phase 4 trials? | Long- term side effects after the drug was marketed |
| What do clinical trials help determine? | The safety and efficacy of the new drug or treatment |
| What are the titles for the key modules submitted as part of the CTD? | - Quality - Non-clinical study reports - Clinical study reports |
| Why should a power calculation be done in planning a phase 3 clinical trial? | To ensure that the outcomes are statistically valid |
| Prior to market authorisation of a new drug, which document is submitted to the regulatory authorities? | The Common Technical Document |
| What is the purpose of phase 1 clinical trials? | To explore the safety of a new drug |
| What is the purpose of Phase 2 clinical trials? | To explore and confirm the efficacy and safety of a new drug |
| What is the purpose of Phase 3 clinical trials? | To confirm the safety and efficacy of a new drug |
| What are Phase 4 trials also known as? | Post-marketing surveillance |
| What is the purpose of the yellow card scheme? | To allow the MHRA to monitor the safety of medicines that are on the market |
| Name 2 types of hypersensitivity toxicological studies | Guinea pig maximization test Local lymph node assay |
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