Semester 1

Question 1

Target search

Answer 1

Literature search

Looking for pharmacoogical targets with disease

Question 2

Target Validation

Answer 2

Test hypothesis

Validate target

Question 3

Lead Generation

Answer 3

Identify lead compounds

improve physiological properties

Question 4

Lead optimisation and evaluation

Answer 4

optimise compounds for clinical testing

efficacy,toxicology,selectivity and pk

Question 5

Clinical trial

Answer 5

a study which assigns a human participant to one or more health-related intervention to evaluate the effects on health outcomes
Phase1: tolerability, pk and safety(50-200)
Phase2: proof of concept, dose and confirm efficacy(100-400)
Phase3: larger studies for regulatory approval(100-5000)
Phase4: safety and efficacy in clinical practice(1000-1mil)

Question 6

In vitro

Answer 6

outside living organism

Question 7

In vivo

Answer 7

inside living organism

Question 8

Ex vivo

Answer 8

inside intact tissue outside a living organisms

Question 9

In silico

Answer 9

using a computer stimulation

Question 10

Quality assurance

Answer 10

ensures high quality and intgretity in clinical and non clinical researchers. GLP,GMP.GCP

Question 11

Post approval for drug

Answer 11

post marketing surveillance to monitor for any change in:

formulation,labelling,dosage and strength

Question 12

Attrition

Answer 12

failure to progresse due to e.g.

Lack of efficacy,safety,PK,formulation,cost,bioavailabilty and commercial

Question 13

Good Clinical Practise(GCP)

Answer 13

ethical and scientifuc quality requirements for clinical trials

Question 14

Investigators Brochure(IB)

Answer 14

summary of clinical and pre clinical data

Question 15

Investigational Medicinal Product(IMP)

Answer 15

its a form of active substance or placebo being tested in a CT

Question 16

IMP Dossier

Answer 16

contains infromation related to the quality, manufacture and control of IMP

Question 17

Summary of product characteristics(SmPc)

Answer 17

legal document after liscesing that contains all information on drug

Question 18

Parallel group

Answer 18

independent group recieving different treatment

Question 19

Crossover

Answer 19

same treatment given in different order to different groups

Question 20

Selection bias

Answer 20

selection of individuals such that randomisation isnt achieved

Question 21

Performance bias

Answer 21

one group recieves more attention than the other

Question 22

Detection bias

Answer 22

systemic differences between groups in how outcomes are determined

Question 23

Attrition bias

Answer 23

difference between groups due to withdrawl from study

Question 24

Observer bias

Answer 24

failure to measure/clasify outcomes appropriately
Interviewer bias(investigator knows placebo)
Recall bias(only report some events by patient)

Question 25

Adverse Drug Event(ADE)

Answer 25

a injury/event occuring during a trial that may or may as a result of the drug

Question 26

Adverse Drug Reaction(ADR)

Answer 26

a injury caused by taking medication

Question 27

Serious Adverse Event(SAE)

Answer 27

any untoward ADE which may result in death,hospitiliisation or its life threatening

Question 28

Suspect Unexpected Serious Adverse Reactions(SUSAR)

Answer 28

a serious ADR where the nature or severity is not consistent with IMP

Question 29

Randomisation

Answer 29

Simple-allocate randomly
Blocks-allocation in blocks
Stratified-in stratas (M&F)
Cluster-in cluster
Manual-in excel
Adaptive-as trial goes

Question 30

Blinding

Answer 30

open- no blinding
Single-only acessor knows
Double-patient and investigator blind
Triple blinding-patient, investigator and accessor blind

Question 31

Placebo

Answer 31

substance which has no therapeutic value/ its inert

acts as control

Question 32

5 R’s

Answer 32

Right target
Right tissue
Right safety
Right commercial potential

Question 33

3 R’s animal research

Answer 33

Replace
Refine
Reduce