Drug development (Lecture 18)

Question 1

What agency looks at Canadian drug development?

Answer 1

PDD (Pharmaceutical Drugs Directorate)

Question 2

Accidental vs Deliberate drug discovery

Answer 2

Accidental -> Unexpected
Deliberate -> Actual research into the molecule

Question 3

What types of tests are in preclinical testings

Answer 3

Animal testing, In Vitro, Structure activity relationships

Question 4

When is the first time that drug is administered in humans

Answer 4

Phase I

Question 5

Describe Phase I trial based on healthy vs unhealthy, # of participants, aim of the trial

Answer 5

Healthy patients (only with a few exceptions)
Up to 100 volunteers (small)
Aimed at examining PK parameters and only some safety

Question 6

What types of drugs are exempt from typical Phase I

Answer 6

Anticancer (too toxic in healthy individuals)
HIV drugs

Question 7

When is the first time that the drug is administered in patients

Answer 7

Phase II trials

Question 8

Describe Phase II trial based on healthy vs unhealthy, # of participants, aim of trial

Answer 8

Unhealthy
Up to 300 participants
Proof of concept (Does it actually work in patients), Safety examinations, Dosage adjustments

Question 9

Describe Phase III trial based on healthy vs unhealthy,, # of participants, aim of trial

Answer 9

Unhealthy
Thousands of patients
Comparisons with existing drugs for safety and efficacy analysis
*Very expensive

Question 10

What is a New Drug Submission (NDS)

Answer 10

Submission containing;
preclinical and clinical
Synthesis and production
packaging, and any safety concerns (ADR)

Question 11

What are the 3 agencies that regulate drug review process in Canada?

Answer 11

PDD (Pahrmaceutical drugs directorate), HPFB (health products and Food branch), Health Canada

Question 12

What are the 2 things manufacturers need to sell drug in Canada

Answer 12

Notice of compliance(NOC) and DIN (Drug information number)

Question 13

How did the COVID-19 vaccine achieve rapid development?

Answer 13

1. Overlapping of clinical trials
2. No major safety concerns were found

Question 14

What does the PMPRB do? (Patented Medicine Prices Review Board)

Answer 14

1. Regulate prices to ensure non-excessive pricing
2. Reviews the ‘Factory gate price’ - Price at which manufactureres sell to wholesalers, hospitals, and pharmacies

Question 15

Function of Canada’s drug agency (CDA)

Answer 15

Provide Health care decision makers with information about optimal use of drugs and health technologies

Question 16

What is a Special Acess Program (SAP)

Answer 16

Allows for practitioners to request drugs unavailable in Canada usually reserved for serious and life threatening conditions

Question 17

Phase IV trials aim

Answer 17

Post-market surveillance -> safety analysis at a large population

Question 18

When is a supplemental NDS needed?

Answer 18

Used when manufacturer changes to product that already has been authorised for sale

Question 19

When is an abbreviated NDS needed?

Answer 19

For generic drug companies -> Not as much information compared to patent company -> Just need to prove that drug works the same was the original and safety is assured

Question 20

What are the common reasons for drug withdrawal?

Answer 20

Safety, Lack of efficacy, Loss of therapeutic interest, poor market performance (money)

Question 21

DIN vs NPN

Answer 21

DIN is for drugs
NPN is for natural health products

Question 22

Excluded substances in the Natural Health Products

Answer 22

Biologics, Injectables, Tobacco, Marijuana