Lecture 2: Drug Development Flashcards
Why is speed important in drug development?
Because development encompasses 2/3 the cost of all R&D, so efficiency is important.
The time spent in development detracts from the period of patent protection once a drug goes to market. Once patent ends then generic competition will sharply reduce revenue.
What is phase 1 of drug development?
What is phase 2 of drug development?
What is phase 3 of drug development?
What is phase 4 of drug development?
Why are secondary outcomes important to measure in drug developments trials?
Because these can show that there is an effect on some aspect of the disease, even if no effect is being seen. This can allow for continuation of development.
What is the main goal of drug development?
What is technical work involved in development?
Aimed mainly at ensuring quality of end product.
Solving technical problems relating to synthesis and formulation, e.g. finding alternative methods of production to enhance yield or production speed.
What do preclinical studies involve in drug development?
How many decision points are there in pre-clinical trials?
What does
What drug was involved in the Northwick Park incident?
TGN1412.
What happened in the Northwick Park incident?
