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Fundamental Of Disease > Drug Pipeline > Flashcards

Drug Pipeline Flashcards

1
Q

What is a drug pipeline

A

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

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2
Q

What are the four stages of the drug development pipeline?

A

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

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3
Q

What is the discovery phase in the drug pipeline?

A

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

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4
Q

What is the preclinical stage

A

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

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5
Q

What is the clinical development stage in the drug pipeline?

A

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

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6
Q

The clinical development of a drug has how many stages?

A

4.

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7
Q

In phase 1 of the clinical development

A

Pharmokinetics, tolerability, side effects, in healthy volunteers

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8
Q

Phase 2 in clinical trial

A

Small scale trials in patients suffering from the disease

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9
Q

Phase 3

A

Large scaled controlled clinical trials,

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10
Q

The during of the clinical trials

A

5-7 years

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11
Q

The during of the pre clinical trial?

A

1.5 years

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12
Q

During of the marketing

A

1 years

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13
Q

Therapeutic index

A

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

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14
Q

Examples of target

A

Receptors, ion channels, enzymes, transporters.

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15
Q

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

A

Assay system

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16
Q

Combinational chemistry

A

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

17
Q

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

A

Yes

18
Q

Can natural products be used to discover leading drugs

A

Yes

19
Q

Penicillin comes from …….

A

A fungi

20
Q

Vincristine derives from

A

A plant

21
Q

List advantages of using natural products

A

Microorganisms are diverse and easy to collect and grow.

22
Q

Disadvantages of using natural products

A

Often complex and hard to synthesis or modify

23
Q

What is lead optimization ?

A

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

24
Q

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

A

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

25
Q

What is pharmacological testing in lead optimization ?

A

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

26
Q

What is preliminary toxicological testing?

A

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

27
Q

What is genotoxity?

A

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

28
Q

Pharmokinetics testing in lead optimization.

A

Absorption, distribution, excretion ( metabolism and Elimination)

29
Q

Chemical and pharmacological development

A

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

30
Q

Clinical trials

A

Long term toxicity studies may be used

Fertility and fetal development

31
Q

Phase I of clinical trials.

A

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

32
Q

Phase ii of clinical trials

A

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

33
Q

Phase III of clinical trial

A 
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.
34
Q

Phase IV of clinical phase

A

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

35
Q

Thalidomide

A

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

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