Drug Design And Developmengt

Question 1

what do MHRA do

What happens in pre clinical phase

Answer 1

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Question 2

Clinical study
Definition
Phases

Answer 2

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Question 3

Clinical studies - examples of bad ethics

What regulates clinical trials

Answer 3

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Question 4

EU clinical trials directive
What does this set out

What about uk clinical trials regulations

Answer 4

Safety and efficacy of humans must be investigated. Quality of conduct

Question 5

Ethical considerations in studies — what conscious / subconscious pressures may there be on investigation and volunteer?

Answer 5

Motives and incentives — interest, financial, promotion, job security

Question 6

Role of ethics committees?

What rights do the volunteers have and what is their responsibility

Answer 6

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Question 7

Volunteers
What can you measure
Special groups?

Answer 7

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Question 8

Difference between phase 2 / 3/ 4 clinical trials

Answer 8

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Question 9

What is NME
What is evergreening
What is me too drugs

Answer 9

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Question 10

What are
Biological medicines
Biosimilar medicines

Answer 10

Biological — from living. Complex molecular entities, difficult to characterise
Biosimilar — v similar to existing medications. Contains an active substance of already approved bio medicine — this s a reference medicine. Eg genotropin and valtropin