1.2 Drug Development, Trials And Advertising

Question 1

Stages in drug development

Answer 1

• Drug Discovery
• Clinical Trials
• Health Canada/FDA Approved Drug

Question 2

Drug Discovery

Answer 2

-3-6 years total
Sub stage 
- research and discovery of target
# of cmpds 
- up to 25,000
Result 
-discovery of lead compounds

Sub stage 
-preclinical testing 
# of cmpds
- up to 30
Result 
- determine safety and potential efficacy

Question 3

Clinical trials (6-7 years total)

Answer 3

Phase 1 
- 5-30 
- safety and tolerability 
Phase 2
- 2-3
- effectiveness, safety, and pharmacokinetics 
Phase 3
- 1
- effectiveness and safety

Question 4

Health Canada/FDA Approved the drug (0.5-2 years total)

Answer 4

Health Canada review and manufacturing 
- 1 
- drug approval and production 
Phase 4
- 1
- long term safety

Question 5

Preclinical studies

Answer 5

Prior to testing new drug in humans tested on molecular and cellular studies, tissue and whole animal studies

Question 6

Toxicology studies

Answer 6

These studies determine the effect of the new drug on organ systems other than the targeted organ. All drugs have some toxicity at some dose in some individuals

Question 7

Pharmacology studies

Answer 7

studies determine the detailed mechanism of action of the new drug for example if the drug has been developed to treat high blood pressure it would be determined how the drug lowers blood pressure

Question 8

Initial steps to test a new drug in humans

Answer 8

1. The manufacturers required to submit proof of the safety and efficacy of the drug in several animal species to the government regulatory agency in the particular country concerned
2. The detailed methodology of the proposed clinical trial in humans is required
3. The submission is carefully evaluated by qualified scientists in the regulatory agency if they are satisfied permission will be given

Question 9

Phase 1 clinical trials

Answer 9

• Trials are conducted in a limited number 20-100 of healthy volunteers
• The absorption distribution elimination and adverse effects of the new drug are carefully studied
• One or two doses of the new drug administered and tolerability of the drug is determined

Question 10

Phase 2 clinical trials

Answer 10

• conducted in patients who have the disease or condition for which the drug is designed to treat
• determine whether the drug is effective in treating the condition it is recommended for
• careful attention is paid to the safety of the drug

Question 11

Phase 3 clinical trials

Answer 11

• Main studies used for the licensing of marketing of the drug
• Test the drug in a larger number of people usually 1000 or more to obtain more info on the safety and efficacy of the drug
• last months to years and are conducted at centres in many cities as one does not have the required number of or diversity of patients
• $1 million-$50 million
• main goal to test whether the drug is save and effective

Question 12

Elements of a clinical trial

Answer 12

Phase 3 clinical trials designed with the same components to ensure that the results are as reliable as possible

Question 13

Target population

Answer 13

Target population must be a group of patients for whom the drug is intended for patients involved in the study would have to have prior diagnosis of the disease of study

Question 14

Inclusion and exclusion criteria

Answer 14

• Patients with multiple diseases that could influence the results are excluded
• there should also be a severity of different levels of the disease

Question 15

Ethical considerations and consent

Answer 15

• Before a person is able to participate consent must be obtained
• consent document should outline the purpose of the study the procedures the effects the risks and the benefits
• patients must fully understand the consent contract before the trial begins

Question 16

Study population randomized allocation

Answer 16

A computer generator will divide patients into a control group and experimental group removing bias

Question 17

Treatment

Answer 17

The patience and the treatment group will receive the experimental drug

Question 18

Control

Answer 18

Experimental drug has to be compared to a controlled drug which will either be a possible gold standard drug depending on the disease

Question 19

Placebo

Answer 19

A tablet that does not contain any active drug but as identical in appearance colour taste in size of the tablet containing the active drug.

Question 20

Gold standard drug

Answer 20

Is the new drug that is excepted by the medical community has the best available treatment for the specific disease at that time

Question 21

Blinded assessment

Answer 21

The staff administration or the patient receiving cannot be aware of who is receiving Which drug to remove bias

Question 22

Outcome

Answer 22

• Result of treatments should be measured in objective and reliable manner
• measuring at the same time each day/taking at the same time each day

Question 23

Compliance

Answer 23

Compliance says if the results of the trial or valid patient usually asked to return their unused drug at the clinic each visit to see the accuracy of the overall compliance

Question 24

Quality of life

Answer 24

• Clinical trials will measure the impact of the drug or treatment on the quality of life
• some drugs may be effective in treating the disease but may not improve the quality of life

Question 25

Analysis of the results

Answer 25

The experimental drug must be compared to the control drug using statistics if successful will be granted approval

Question 26

Bioavailability studies

Answer 26

• new brand name drugs and the generic drug will contain the identical active ingredients as the original brand name drug, in the same amount and usually in the same dosage form

Question 27

Bioavailability

Answer 27

The proportion of an administered dose of a drug that reaches the systemic circulation in an unchanged form

Question 28

Bioequivalent

Answer 28

The two drug products generic and brand-name which contain the same active ingredients and give similar blah blah those are said to be bioequivalent

Question 29

Phase 4 clinical trials

Answer 29

Risks that are delayed or less frequent than 1 in 1000 administrations may be missed in the phase 3 trial. Thus, surveillance of the effects of the drugs are required after the drug is released for general use
- referred to as the post marketing surveillance