Lecture 2

Question 1

The process through which (potential new medicines) are identified called ?

Answer 1

Drug discovery

Question 2

Drug discovery involves a wide range of scientific disciplines , mention them :

Answer 2

1- biology
2- chemistry
3- pharmacology

Question 3

The process of developing a new drug that effectively targets a specific weakness in a cell called ?

Answer 3

Drug development

Question 4

Drug development involves pre-clinical development and testing, followed by _______ , to ______ .

Answer 4

1- trials in humans ,
2- determine the efficacy of the drug .

Question 5

There are 3 disadvantages when development of new drugs , mention them ?

Answer 5

1- complex
2- costly
3- risky

Question 6

The science and activities relating to the detection, assessment, understanding and prevention of adverse ——>(ضارة) effects or any other possible drug-related problems is ?

Answer 6

Pharmacovigilance

Question 7

Give me the steps that we need to investigational drug succes :

Answer 7

• Discovery/Screening: 5000-10,000
• Enter Preclinical Testing: 250
• Enter Clinical Testing: 5
• Approved by Regulatory Bodies: 1

Question 8

The process which implies the ability to predict the chemical structure of drug molecule on basis of (3-dimensional )structure of its receptor, employing at present suitable computer programs callled ?

Answer 8

Rational drug design

Question 9

Many drugs in clinical use at present were developed in the rational way! (T/F)

Answer 9

F
(Only few drugs in clinical use at present were developed in this rational way) .

Question 10

Most drugs were in the past developed through two method , mention them: 😊

Answer 10

1- random testing of chemicals
2- modified molecules of known drugs that are known to have some other pharmacological effect.

Question 11

rational drug design with aid of computers will become more feasible , give me the reason

Answer 11

As more would become known about detailed structure of receptors.

Question 12

Phase 1,2,3 consider as ?

Answer 12

Clinical testing

Question 13

Give me the Steps of drug development :

Answer 13

A. In vitro studies
B. Animal testing
C. Clinical testing
D. Marketing

Question 14

Pre-clinical Testing divided to three parts , mention them:

Answer 14

1- Determine pharmacokinetic parameters ( Absorption, distribution, metabolism…etc)
2- Determine pharmacodynamics (MOA)
3- Assessment of drug toxicity=safety

Question 15

We can assessment of drug toxicity=safety be several studies , mention them:

Answer 15

1- Acute toxicity studies
(Determination of LD50; Margin of safety…etc)
2- Sub-acute and chronic toxicity studies
3- Repeated dose studies.

Question 16

To correctly define the limiting toxicities of drugs and the therapeutic (((index))) comparing benefits and risks of a new drug is ?

Answer 16

Pre-clinical safety and toxicity testing .

Question 17

Mention the parameters measured during pre-clinical phase

Answer 17

1- “no-adverse effect” dose
2- The minimum lethal
3-The median lethal dose (LD50).

Question 18

The most essential part of the new drug development process is ?

Answer 18

Pre-clinical safety and toxicity testing

Question 19

the smallest dose that is observed to kill any experimental animal is ?

Answer 19

The minimum lethal

Question 20

the dose that kills approximately 50% of the animals is ?

Answer 20

The median lethal dose (LD50)

Question 21

the maximum dose at which a specified toxic effect is not seen is ?

Answer 21

“no-adverse effect”dose

Question 22

Example in slide 13 is ?

Answer 22

Very very very very important bro 🔥.

Question 23

Mention the ethics of the use of drugs in humans ?

Answer 23

• Full detailed protocol has to be approved by the ethical committee, the institutional review board (IRB)
• All subjects should sign an informed agreement form
• All subjects should be insured for life and damage

Question 24

Give me overview about Clinical trials’s phases :😊

Answer 24

A. Phase 1 – normal volunteers: safety, pharmacokinetics
B. Phase 2 – selected patients: therapeutic efficacy, dose range
C. Phase 3 – large populations of selected patients: therapeutic efficacy, safety in double blind studies

Question 25

Give me two features of phase 1:

Answer 25

- Observes the effect of drug as a function of dosage - Small number of ((healthy volunteers)) (25-50)

Question 26

The Goal of phase 1 is ?

Answer 26

To find maximum tolerated dose .

Question 27

Mention the condition in which patients with disease are used rather than normal volunteers :

Answer 27

(cancer, AIDS, i.e. drugs with significant toxicity) .

Question 28

Phase I Detect safety & pharmacokinetics (T/!F)

Answer 28

T 😱

Question 29

Give me the features of Phase II :

Answer 29

- Drug studied in patients with the target disease to determine efficacy - Number of patients is 100-200 - Single-blind design with a placebo & positive control - Detects broader range of toxicities

Question 30

Now , give me the features of Phase III ? 😊

Answer 30

- Larger number of patients (e.g. Thousands) - Conducted to ((minimize errors)) caused by placebo effects, variable cause of the disease etc - Further study of safety & efficacy

Question 31

FDA means?

Answer 31

Food and Drug administration

Question 32

For what the FDA may permit extensive but controlled marketing of a new drug ((before phase 3 studies are completed )).

Answer 32

For serious diseases

Question 33

FDA may permit controlled marketing even before phase 2 studies have been completed for ?

Answer 33

For life threatening disease.

Question 34

What happens Once approval to market the drug has been obtained

Answer 34

phase 4 begins🔥

Question 35

What is the function of phase 4 ?

Answer 35

monitoring the safety of the new drug under actual conditions of use in large numbers of patients

Question 36

Phase 4 has no fixed duration (F/T) ?

Answer 36

T 😉

Question 37

Some rare toxicities are unrevealed ? (T/F)

Answer 37

F (Some rare toxicities are revealed (low incidence) )

Question 38

After all these clinical drug trials the drug is usually approved by national or International regulatory authorities and is licensed for General prescribing

Answer 38

Love u all 💕

Question 39

Overdose midterm selected questions: *In which drug discovery phase the acute toxicity level is determined? a) Phase I b) Phase II c) Phase II d) Preclinical testing

Answer 39

D

Question 40

Vagus midterm selected questions: * Regarding the drug development process, which one of the following combinations is correct?

Answer 40

Phase ꓲꓲꓲ+ involves crossover techniques

Question 41

phase 0 " or " first in human " trials were approved by the FDA in 2006. which one of the following statements is correct regarding these trials during drug development process?

Answer 41

these studies enable go / no go decisions to be based on relevant human models instead of relying on sometimes inconsistent animals’ data.

Question 42

*During drug development process and before testing drugs on human, a full detailed protocol has to be approved by the ethical committee. which of the following is considered as an ethical committee? Answer:

Answer 42

IRB (institutional review board)