Module 1 - Drug Development

Question 1

What is a disease

Answer 1

Interferes with normal state, causes abnormal function of system, part, or organ.

Question 2

What is a disease defined by?

Answer 2

-Recognition of etiologic agents
-identifiable signs and symptoms
-consistent anatomical alterations

Question 3

Aetiology

Answer 3

Genes play into disease, environment can turn a gene on

Question 4

Drug

Answer 4

Agent for diagnosis, treatment, cure, or prevention

A poison

Question 5

Lead Compound

Answer 5

Prototype for fundamental and desired activity of drug
may not yet posses all desired features

Question 6

Prodrug and why we use it

Answer 6

-Metabolically transformed after administration to be activated.
-Controlled release, targeting, stability, distribution, optimal solubility, permeability (in gut), extended effects

Question 7

Dosage Form and uses for altering drug forms

Answer 7

How a drug is prepared for patient and its delivery system
-can reduce toxicity, conceal taste/smell, patient convenience, accurate administration, decomposition protection.

Question 8

When is chemical name given to a drug

Answer 8

At initial discovery with its empirical formula

Question 9

When is generic/nonproprietary name given?

Answer 9

When drug shows promise

Question 10

When is proprietary/brand name given

Answer 10

When developed and marketed

Question 11

Pharmaceutics

Answer 11

Formulation and drug manufacture
-physical, chemical, and biological factors that influence the stability and effectiveness. Considered during formulation and manufacturing

Question 12

Biopharmaceutics

Answer 12

Study of drug properties and dosage form after administration
-involves pharmacokinetics (absorption, distribution, metabolism, and excretion)

Question 13

What is Pharmacokinetics concerned with?

Answer 13

What the body does to a drug

Question 14

What is considered a new drug?

Answer 14

Drug not recognized as safe and effective, new chemical entity

Question 15

What are the three American Drug Regulators?

Answer 15

Food, Drug and Cosmetic Act
Food and Drug Administration (FDA)
New Drug Application (NDA)

Question 16

What are the three Canadian drug regulators?

Answer 16

Food and Drug Act
Health Canada
New Drug Submission (NDS)

Question 17

How long is the drug discovery process, how many make it to human testing, what is the total cost of a new drug?

Answer 17

10-12 years, 5/10,000 drugs, 2.6 billion

Question 18

What are the first two processes of drug discovery that take 2-6 years. How many drugs are in this process?

Answer 18

Discovery and preclinical trials. 5000-10000 in discovery and 250 in preclinical.

Question 19

What are the three phases of clinical trials? how many participants are included in each phase?

Answer 19

Phase 1: 20-100 participants. Checks safety profile and microkinetics.
Phase 2: 100-500 participants. Finding correct dose and finding efficacy.
Phase 3: 1000-5000 participants. Test safety and efficacy on a larger scale

Question 20

What form is submitted before clinical trials

Answer 20

Investigational new drug form (IND)

Question 21

What form is submitted after clinical trials?

Answer 21

New drug Application Form (NDA)

Question 22

What two processes occur after clinical trials?

Answer 22

FDA review then scale up to MFG (0.5-2 years)

Question 23

When does the formulation process occur?

Answer 23

During pre-clinical trials

Question 24

What is treatment requested by a physician that is not approved yet?

Answer 24

Special access programme (SAP)

Question 25

What does NDS stand for

Answer 25

New Drug Submission

Question 26

What is the role of CADTH

Answer 26

Economic decisions for affordability.

Question 27

What is PMPRB

Answer 27

Patented Medicine Price Review Board. Regulates medication price to ensure access is possible

Question 28

Why do biologics take longer to approve?

Answer 28

High complexity and finding an expert that can review it

Question 29

What does postmarketing look for

Answer 29

-Removal if new side effects arise that were absent in lab -Watch for indication of possible new drug -Phase 4 clinical adverse reaction report

Question 30

What are some methods of Patent Protection

Answer 30

Superior clinical formulations New administration routes Chiral switching More than one usage

Question 31

Innovator Product

Answer 31

Brand name developed by innovator of first product

Question 32

Generic Product (what application form is needed?)

Answer 32

Copy of brand name when patent is expired Abbreviated New Drug Application

Question 33

Bioequivalence

Answer 33

Seemingly equivalent products may vary due to formulation and manufacturing. Use dissolution testing to ensure new drug is equivalent to original patent.

Question 34

What information is sought during post-marketing surveillance

Answer 34

Adverse reaction, defect reporting, product line extension-modified version

Question 35

Where does a drug interfere?

Answer 35

Symptoms & Disabilities. Controls/stops them.

Question 36

Diagnosis drug example

Answer 36

Radioactive bio markers for cancer diagnosis

Question 37

Prognosis drug example.

Answer 37

Inhaler for asthma. Controls prognosis and prevents from getting worse

Question 38

What happens if is drug is given to a healthy individual?

Answer 38

Interacts with biological processes and causes side effects. Even if it’s a benign drug it is still a poison.

Question 39

Drug Product

Answer 39

Preparation/formulation of a drug Has: active ingredient, additives, dosage form, method of preparation