Drug Pipeline

Question 1

What is a drug pipeline

Answer 1

A drug pipeline is a set of drugs candidates that a pharmaceutical company has on trial or development at any given time

Question 2

What are the four stages of the drug development pipeline?

Answer 2

1) discovery
2) pre- clinical
3) clinical trials
4) marketing

Question 3

What is the discovery phase in the drug pipeline?

Answer 3

Involves the selection of the candidate molecules on the basis of their pharmaceutical properties.

Question 4

What is the preclinical stage

Answer 4

A wide variety of non human studies. Toxicity, pharmokinetics, formulation of the drug.

Question 5

What is the clinical development stage in the drug pipeline?

Answer 5

Select compounds is tested for efficacy, side effects and potential dangers.

Question 6

The clinical development of a drug has how many stages?

Answer 6

4.

Question 7

In phase 1 of the clinical development

Answer 7

Pharmokinetics, tolerability, side effects, in healthy volunteers

Question 8

Phase 2 in clinical trial

Answer 8

Small scale trials in patients suffering from the disease

Question 9

Phase 3

Answer 9

Large scaled controlled clinical trials,

Question 10

The during of the clinical trials

Answer 10

5-7 years

Question 11

The during of the pre clinical trial?

Answer 11

1.5 years

Question 12

During of the marketing

Answer 12

1 years

Question 13

Therapeutic index

Answer 13

indicates how safe a drug is to be used at a low dose.

Question 14

Examples of target

Answer 14

Receptors, ion channels, enzymes, transporters.

Question 15

How would you determine the functional activity of a protein target?

Answer 15

Assay system

Question 16

Combinational chemistry

Answer 16

A method of reacting a small number of chemicals to produce simultaneously a large umber of compound

Question 17

Does high molecular weight, excessive polarity and possession lead to toxity?

Answer 17

Yes

Question 18

Can natural products be used to discover leading drugs

Answer 18

Yes

Question 19

Penicillin comes from …….

Answer 19

A fungi

Question 20

Vincristine derives from

Answer 20

A plant

Question 21

List advantages of using natural products

Answer 21

Microorganisms are diverse and easy to collect and grow.

Question 22

Disadvantages of using natural products

Answer 22

Often complex and hard to synthesis or modify

Question 23

What is lead optimization ?

Answer 23

Increasing the potency of the compound units drug target. Requires a lot of testing especially on small animals.

Question 24

What are the main categories for testing for drugs in lead optimum

Answer 24

1) pharmacological testing
2) preliminary toxicology testing
3) pharmacokinetics testing
4) chemical and pharmacological development

Question 25

What is pharmacological testing in lead optimization ?

Answer 25

Determining if the compound has obvious acute effects, such as bronchioconstrictions, cardiac dysrhythmias, change in BP, ataxia

Question 26

What is preliminary toxicological testing?

Answer 26

To eliminate genotoxicity and to determine a non toxic dose. Checking for gross features such as weightless as well as histological and biochemically features

Question 27

What is genotoxity?

Answer 27

genotoxicity describes a deleterious action on a cell's genetic material affecting its integrity

Question 28

Pharmokinetics testing in lead optimization.

Answer 28

Absorption, distribution, excretion ( metabolism and Elimination)

Question 29

Chemical and pharmacological development

Answer 29

Assess the feasibility of large scale synthesis and purification assess stability of compounds under conditions develop a formulation for clinical trials

Question 30

Clinical trials

Answer 30

Long term toxicity studies may be used | Fertility and fetal development

Question 31

Phase I of clinical trials.

Answer 31

80- 100 healthy volunteers Checking the pharmokinetics properties Pharmocdynamics effects To determine safety on the heart, kidney etc

Question 32

Phase ii of clinical trials

Answer 32

100- 300 patients Efficacy Establish dose in phase iii Involves studies which includes a wide range of disorders

Question 33

Phase III of clinical trial

Answer 33

``` 1000- 3000 patients Comparison of the new drugs with alternatives Pharmoeconiomics Detail of the patient group Data collection Statistical analysis Documentation Regulatory agents are introduced for licensing of the drug. ```

Question 34

Phase IV of clinical phase

Answer 34

Involves marketing surveillance to determine rare long term adverse effects. This may be limited to persons withdrawing

Question 35

Thalidomide

Answer 35

A drug given in the 1960 to pregnant women who had morning sicknesses. The children who born with birth defects especially in the limbs