Lecture 2: Introduction P2

Question 1

What are the five (5) stages of drug development?

Answer 1

1. Drug discovery
2. Drug development
3. Clinical trials
4. Manufacturing
5. Marketing application

Question 2

How long does drug development take?

Answer 2

10 - 12 years

Question 3

What is pre clinical testing?

Answer 3

Test the safety and effectiveness of the drug. Where Scientist will determine how it affects carcinogenicity, toxicity, mutagenicity and reproductive development.

Question 4

What does IND mean in drug development?

Answer 4

Investigational New Drug

Question 5

What happens in IND (Investigational New Drug) Application ?

Answer 5

This is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

Question 6

What does Phase I drug development test for?

Answer 6

the safety of the drug as well as Pharmacokinetics (ADME) and pharmacodynamics.

Question 7

What does Phase II test for in drug development?

Answer 7

Tests safety and effectiveness of the drug

Question 8

How many volunteers are used in Phase I of drug development?

Answer 8

Usually involves 20 – 80 healthy volunteers

Question 9

How long does Phase I take in drug development?

Answer 9

May take a year

Question 9

Who is testing done on in Phase II of drug development?

Answer 9

Usually about 100 – 300 patient volunteers who have the condition the drug was designed to treat.

Question 9

How long does Phase II of drug development last?

Answer 9

Can take up to 2 years

Question 10

What is done in Phase III of drug development?

Answer 10

The efficacy of the drug is further tested in this phase

Question 11

Who is testing done on in Phase III of drug devlopment?

Answer 11

These are done on more patients are used, approximately 1000 –
3000.

Question 12

How long does Phase III of drug development take?

Answer 12

May take 3 years

Question 13

Where are Phase III volunteers found?

Answer 13

Conducted in several hospitals or clinics in different demographic locations.

Question 14

What is New Drug Application (NDA)?

Answer 14

This is a document tht includes enough information for the FDA to determine whether the new drug is safe and effective; whether the drug’s benefits outweigh its risks; whether the proposed drug label (package insert) is appropriate; and whether the drug manufacturing standards are adequate.

Question 15

How long can it take to for a NDA in drug development to be filed?

Answer 15

2 ½ years

Question 16

What is Phase IV of drug development?

Answer 16

This is a post marketing trial to assess the drug in an uncontrolled, real-life situation.

Question 17

What is the point of Phase IV of drug development?

Answer 17

To determine if the drug still does what it was proposed to do including any cases of adverse reactions.

Question 18

What is drug disposition?

Answer 18

this is the four major events that occur once a drug has been adminstered.

Question 19

The effect of a drug can be defined as….

Answer 19

local or systemic

Question 20

What is a local reaction?

Answer 20

A local reaction is one that takes place at the specific site of application, such as the gastrointestinal tract (GIT) in the case of oral administration or the epithelial layer in the case of topical application.

Question 21

What is systemic effects?

Answer 21

Systemic effects are effects that are produced at a site other than the site of application.

For example, the oral administration of an analgesic agent, which effectively applies the drug to the GIT, may influence a distant location such as the brain.

Question 22

What are some mechanisms by which interaction of chemical may occur?

Answer 22

1. Protein Binding
2. Biotransformation
3. Excretion
4. Absorption

Question 23

What are some drug interaction?

Answer 23

1. Behavioural drug 2. Pharmaceutic drug 3. Pharmacokinetic drug 4. Pharmacodynamic drug

Question 24

What is Behavioural drug interaction ?

Answer 24

Interactions occur when one drug alters the patient’s behaviour to modify compliance with another drug.

Question 25

What is Pharmaceutical drug interaction ?

Answer 25

Pharmaceutical interactions occur prior to the administration of drugs to patients and generally represent incompatibilities of drugs administered via intravenous infusion.

Question 26

What is Pharmacokinetic drug interaction?

Answer 26

Interactions occur when one drug changes the systemic concentration of another drug, altering ‘how much’ and for ‘how long’ it is present at the site of action.

Question 27

What is Pharmacodynamic drug interaction?

Answer 27

Interactions occur when interacting drugs have additive effects, where the overall effect is increased. Can be opposing effects, where the overall effect is decreased or ‘cancelled.

Question 28

What are the types of pharmacodynamic chemical interactions ?

Answer 28

1. Additive 2. Synergistic 3. Potentiation 4. Antagonism

Question 29

What is additive interaction effect?

Answer 29

This action occurs when the combined effect of two or more chemicals is equal to the sum of the effect of each agents given alone. (2+2 = 4)

Question 30

What is synergistic interaction effect?

Answer 30

This action occurs when the effect caused when exposure to two or more chemicals at one time results in health effects that are greater than the sum of the effects of the individual chemicals. (4+5=15)

Question 31

What is potentiation interaction effect?

Answer 31

A chemical that is usually nontoxic, becomes greatly toxic due to the introduction of another chemical (0+5=15).

Question 32

What is the antagonism interaction effect?

Answer 32

This is the reduction of a chemicals (toxin/toxicant) effect due to the presence of another chemical (4+2=1).

Question 33

What are types antagonistic interactions?

Answer 33

1. Functional 2. Chemical (Inactivation) 3. Dispositional

Question 34

What is Dispositional antagonistic interactions ?

Answer 34

Reduction of toxicity from a substance, due to alterations made to either A, D, M and/or E.

Question 35

What is Functional antagonistic interactions?

Answer 35

Administration of one chemical counterbalances the effect of another chemical on the same physiological function.

Question 36

What is chemical antagonistic interactions?

Answer 36

The interaction of two compounds, producing a less toxic product.

Question 37

What is warfarin?

Answer 37

Water-soluble compound with anticoagulant properties that used as rat poison and in the treatment of thrombosis.

Question 38

What is receptor antagonistic interaction?

Answer 38

Reduction of toxic effects due to two or more compounds binding to the same receptor.

Question 39

What are the mechanism of tolerance?

Answer 39

1. Decreased amount of toxin/toxicant reaching the target site (Dispositional Tolerance). 2. Decrease responsiveness of the tissue to the chemical present.