variation, cpr and ethics

Question 1

What is a polymorphism in people for MDMA

Answer 1

CYP2D6, man dies of organ failure after taking MDMA

Question 2

The absorption in elderly is higher/lower compared to adults

Answer 2

lower

Question 3

An increase in adipose tissue leads to

Answer 3

a decrease in clearance and volume distribution, but an increase in vd of lipids.

Question 4

What happens during pregnancy?

Answer 4

-lower plasma albumin levels
- heart-stroke volume increased
- renal clearance increased
- lipophilic drugs cross the blood-placenta barrier

Question 5

The toxic effect on eldery is a lot higher compared to adults

Answer 5

okay

Question 6

What is the difference between phase 1,2,3,4

Answer 6

phase 1: is it safe? side effects in healthy volunteers
phase 2: assess efficacy and dosage, patients
phase 3: large-scale controlled clinical trial, duur
phase 4: postmarketing surveillance, compare to other drugs, effects in special populations

Question 7

What do you do with a bioassay?

Answer 7

Establish concentration and/or determine potency of a drug based on a biological response. It helps scientists figure out the effectiveness of a drug and how much of it is needed to produce a specific effect in the body.

Question 8

What is a randomized clinical trial?

Answer 8

The aim is to compare between a novel and a current clinical treatment or placebo. You compare groups in a controlled setting, it is double blind.

Question 9

What is the LD50?

Answer 9

This is at which 50% of the population dies

Question 10

What does NTT stand for?

Answer 10

the number of subjects needed to treat to find an effect (3 effect, 3 subjects need to be treated to measure an effect in 1 subject)

Question 11

What is pharmacoeconomics?

Answer 11

Study of net economic impact of drug selection and use on total cost of delivering health care. it helps people decide if a drug is cost-effective by looking at both the price and the benefits it brings.

Question 12

What is pharmacovigilance?

Answer 12

Drug safety when it is already on the market
- adverse effects
- ineffectiveness
- misuse and overdose
- use during pregnany and breastfeeding

Question 13

What does prevention of therapeutic fallacy mean?

Answer 13

That people who join a research where drugs are used, know whether it benefits themselves or not

Question 14

How is scientific validity judged?

Answer 14

• knowledge/data cannot be obtained without the participation of humans
• clear objectives and sound scientific argumentation
• adequate methodology and statistics (sufficient number of participant, but not too much)
• expertise of investigators