Licensing a new drug

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Clinical trials
Simeon Crane
Flashcards by Simeon Crane, updated more than 1 year ago
Simeon Crane
Created by Simeon Crane over 5 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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