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PY367 Licensing a new drug

This class was created by Brainscape user samantha sami. Visit their profile to learn more about the creator.

By: samantha sami
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Decks in this class (9)

Intro to case
Outline the drug discovery process,
What is remdesivir used for,
What is elixir sulphanilamide use...
14  cards
Clinical trials
What are the aims of a scientific...,
What does the scientific method i...,
What do detailed scientific studi...
20  cards
Stages I, II, III, and IV of clinical trials
What does a clinical trial involve,
What are the requirements of the ...,
What are the ich guidelines for g...
32  cards
Pharmacological and toxicological profiling
What can molecular biology in vit...,
What is pharmacodynamics,
What is pharmacokinetics
25  cards
Understanding clinical trial data
How do you demonstrate evidence o...,
How do you demonstrate efficacy,
What does an arr of 008 mean
29  cards
Critical appraisal skills programme
Give examples of sources of infor...,
What is involved in the critical ...,
What are the steps in making an a...
17  cards
Routes to a new drug application submission
What 3 centres is the mhra formed of,
What are the roles of the fda,
What is the cder responsible for
12  cards
Case study of published trial
Describe the structure of a publi...,
What should be included in the me...,
What are the outcome measures in ...
9  cards
Case roundup
What does gene therapy involve,
What does immunotherapy involve,
What is the gene therapy kymriah ...
7  cards

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PY367 Licensing a new drug

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