16: Regulatory Science

Question 1

in terms of health care costs, what gets more spending, maintenance of good health or treating late stage diseases

Answer 1

treating late stage diseases

Question 2

4 steps in the process of discovery

Answer 2

basic research
translational research
applied research
apply to consumers for cures, treatments, and prevention

Question 3

sources of new drugs may come from

Answer 3

new chemical entity by organic synthesis
lead compound modifications to already existing compounds
natural sources like plants and animals
genetic developments

Question 4

3 aspects of the genetic field of drug development

Answer 4

recombinant DNA
monoclonal antibodies
human gene therapy

Question 5

_________ is a technology that uses enzymes to cut and paste together DNA sequences of interest. these pieces are then put into vectors to be expressed by host cells

Answer 5

recombinant DNA

Question 6

what kind of genetics based drugs can be used to detect HCG

Answer 6

monoclonal antibody

Question 7

what is included in the research and development stage of drug development

Answer 7

finding intrinsic dissolution, solubility, physiochemical properties, etc

Question 8

what is the last step in the early development of drugs

Answer 8

provisional BCS classification

Question 9

Directly relates to the tendency of a substance to prefer one phase (liquid, solid, gas) over another
a measure of the “real” partial pressure or pressure of a gas in comparison to ideal gas

Answer 9

fugacity

Question 10

liquid crystal ____ ratio may be used as a surrogate parameter for intestinal permeability

Answer 10

fugacity

Question 11

when there is a health claim, the product must be a ____ or ____

Answer 11

NHP or non-Rx drug

Question 12

______: use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms

Answer 12

drugs

Question 13

define a NHP

Answer 13

A substance or combination of substances set out on Schedule 1 of the Regulations, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:
The diagnosis, treatment mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans
Restoring or correcting organic functions in humans; or
Modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Question 14

what medications are suitable for self care

Answer 14

non-Rx

Question 15

what are not NHPs

Answer 15

schedule 2 excluded substances like radiopharmaceuticals and biologics

Question 16

main factors for determining if a product is a NHP, non-Rx, or cosmetic

Answer 16

presence of health claim

ingredients

Question 17

how many years on average, from early lab testing, does it take for a new drug to be approved for general public

Answer 17

8-9 years

Question 18

what are INDs

Answer 18

investigational new drug

Question 19

T or F: a IND only includes small molecule drugs, not biological products

Answer 19

F- includes biological products used in vitro for diagnostic purposes

Question 20

tendency of a substance to prefer one phase over another

Answer 20

fugacity

Question 21

octanol fugacity is a surrogate for

Answer 21

membrane permeability

Question 22

food and drugs act catagories

Answer 22

medical cannabis regulation
food and drug regulations
medical devices regulations
NHP regulations
cosmetics regulations

Question 23

what regulatory framework applies to health products in canada with one set of regulations for food and drugs and one for natural health products

Answer 23

food and drug act

Question 24

the food and drugs act has one set of regulations for _______ and one for ________

Answer 24

food and drugs

NHPs

Question 25

T or F: NHPs are not suitable for self care and require pharmacist intervention

Answer 25

F- suitable

Question 26

\ a company wants to market a popular herbal remedy as a IM shot. Would it be classified as a NHP ?

Answer 26

no. NHP can't be administered by puncturing skin

Question 27

T or F: certain antibiotics are NHP

Answer 27

F

Question 28

anything on schedule 2 is 1. okay for self directed use 2. a NHP 3. excluded substances to NHPs 4. prescription medication

Answer 28

3

Question 29

what is schedule 1 1. NHPs 2. parenteral adminstered meds 3. substances under the tobacco act 4. antibiotics

Answer 29

1

Question 30

a toothpaste with fluoride is considered a 1. cosmetic 2. NHP 3. non-Rx drug 4. Rx- drug 5. 2 and 3

Answer 30

5

Question 31

toothpaste without fluoride is considered a 1. cosmetic 2. NHP 3. non-Rx drug 4. Rx- drug 5. 2 and 3

Answer 31

1

Question 32

______ can not include claims about your health 1. cosmetic 2. NHP 3. non-Rx drug 4. Rx- drug 5. 2 and 3

Answer 32

1

Question 33

antiperspirants, under health canada, are considered 1. NHP 2. non-Rx 3. cosmetics

Answer 33

1

Question 34

the USA has _____ while canada has _______ for trialing new drugs

Answer 34

``` USA = investigational new drug application (IND) canada = clinical trial application phases 1, 2, 3 ```

Question 35

goal at the end of phase 3 clinical trials for USA = _________, canada __________

Answer 35

``` USA = new drug application (NDA) canada = new drug submission ```

Question 36

before an IND, the sponsor must first submit data showing that the drug is ________ for use in initial, ________

Answer 36

reasonably safe | small scale clinical studies

Question 37

what options do researchers have for showing the drug is safe for use in initial studies

Answer 37

compiling existing nonclinical data previous clinical data new preclinical data

Question 38

tests performed before IND

Answer 38

genotoxicity ADMA investigations toxicity of metabolites

Question 39

what are 3 things, at minimum, the FDA will ask the sponsor to provide at the preclinical stage

Answer 39

pharmacological profile of drug determine acute toxicity in at least 2 species of animals conduct short term studies of 2wks-3months

Question 40

in animal testing, generally how many species are needed

Answer 40

2 or more

Question 41

______ represent the ultimate premarket testing ground for unapproved drugs

Answer 41

clinical trials

Question 42

what is the single most important factor in approval/ disapproval of a new drug

Answer 42

clinical trial results

Question 43

what phase of clinical trials looks at structure activity relationships

Answer 43

phase 1

Question 44

what phase of trials looks for therapeutic windows

Answer 44

phase 2

Question 45

T or F: early evidence of effectiveness may be gained in phase 1

Answer 45

T

Question 46

what is the purposes of a clinical hold

Answer 46

so the CDER can stop a trial if safety or other factors were not disclosed and cause risk

Question 47

in what phase of clinical trials do we first see patients with the disease we want to treat

Answer 47

phase 2

Question 48

what phase is done to evaluate the overall benefit risk relationship of a drug to provide info for physician labeling

Answer 48

phase 3

Question 49

what is an uncontrolled trial

Answer 49

no participants taking placebo/ alternate therapy

Question 50

what is the average time to process a review for a new drug (After clinical trials are completed)

Answer 50

18 months

Question 51

what phase is post marketing studies

Answer 51

4

Question 52

which of the following is true for biosimilar drugs 1. it relies on new information about safety, efficacy and effectiveness 2. is a biologic that gets market authorization after a version prev authorized in canada + demonstrates similarity to the reference product 3. previously referred to as subsequent reference biologics

Answer 52

2

Question 53

T or F: all gennerics sold in canada must be made in canada

Answer 53

T

Question 54

the FDA considers 2 products bioeq if

Answer 54

90% CI of the relative mean Cmax, AUC of comparing test to reference is within 80-125% in the fasting state

Question 55

why is 80-125% considered bioeq?

Answer 55

arbitrary | not 80-120% because PK parameters for exposure (AUC and Cmax) are log distributed

Question 56

______ bioavailability is reported when the product is an oral solution of an oral solid dosage form

Answer 56

relative

Question 57

_____ bioavailability is reported when the reference product is an IV dosage form

Answer 57

absolute