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Y2S1 302 > 16: Regulatory Science > Flashcards

16: Regulatory Science Flashcards

1
Q

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

A

treating late stage diseases

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2
Q

4 steps in the process of discovery

A

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

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3
Q

sources of new drugs may come from

A

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

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4
Q

3 aspects of the genetic field of drug development

A

recombinant DNA
monoclonal antibodies
human gene therapy

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5
Q

_________ 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

A

recombinant DNA

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6
Q

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

A

monoclonal antibody

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7
Q

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

A

finding intrinsic dissolution, solubility, physiochemical properties, etc

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8
Q

what is the last step in the early development of drugs

A

provisional BCS classification

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9
Q

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

A

fugacity

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10
Q

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

A

fugacity

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11
Q

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

A

NHP or non-Rx drug

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12
Q

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

A

drugs

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13
Q

define a NHP

A

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.

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14
Q

what medications are suitable for self care

A

non-Rx

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15
Q

what are not NHPs

A

schedule 2 excluded substances like radiopharmaceuticals and biologics

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16
Q

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

A

presence of health claim

ingredients

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17
Q

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

A

8-9 years

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18
Q

what are INDs

A

investigational new drug

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19
Q

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

A

F- includes biological products used in vitro for diagnostic purposes

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20
Q

tendency of a substance to prefer one phase over another

A

fugacity

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21
Q

octanol fugacity is a surrogate for

A

membrane permeability

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22
Q

food and drugs act catagories

A 
medical cannabis regulation
food and drug regulations
medical devices regulations
NHP regulations
cosmetics regulations
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23
Q

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

A

food and drug act

24
Q

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

A

food and drugs

NHPs

25
Q

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

A

F- suitable

26
Q

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

A

no. NHP can’t be administered by puncturing skin

27
Q

T or F: certain antibiotics are NHP

A

F

28
Q

anything on schedule 2 is

  1. okay for self directed use
  2. a NHP
  3. excluded substances to NHPs
  4. prescription medication
A

3

29
Q

what is schedule 1

  1. NHPs
  2. parenteral adminstered meds
  3. substances under the tobacco act
  4. antibiotics
A

1

30
Q

a toothpaste with fluoride is considered a

  1. cosmetic
  2. NHP
  3. non-Rx drug
  4. Rx- drug
  5. 2 and 3
A

5

31
Q

toothpaste without fluoride is considered a

  1. cosmetic
  2. NHP
  3. non-Rx drug
  4. Rx- drug
  5. 2 and 3
A

1

32
Q

______ can not include claims about your health

  1. cosmetic
  2. NHP
  3. non-Rx drug
  4. Rx- drug
  5. 2 and 3
A

1

33
Q

antiperspirants, under health canada, are considered

  1. NHP
  2. non-Rx
  3. cosmetics
A

1

34
Q

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

A 
USA = investigational new drug application (IND)
canada = clinical trial application phases 1, 2, 3
35
Q

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

A 
USA = new drug application (NDA)
canada = new drug submission
36
Q

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

A

reasonably safe

small scale clinical studies

37
Q

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

A

compiling existing nonclinical data
previous clinical data
new preclinical data

38
Q

tests performed before IND

A

genotoxicity
ADMA investigations
toxicity of metabolites

39
Q

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

A

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

40
Q

in animal testing, generally how many species are needed

A

2 or more

41
Q

______ represent the ultimate premarket testing ground for unapproved drugs

A

clinical trials

42
Q

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

A

clinical trial results

43
Q

what phase of clinical trials looks at structure activity relationships

A

phase 1

44
Q

what phase of trials looks for therapeutic windows

A

phase 2

45
Q

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

A

T

46
Q

what is the purposes of a clinical hold

A

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

47
Q

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

A

phase 2

48
Q

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

A

phase 3

49
Q

what is an uncontrolled trial

A

no participants taking placebo/ alternate therapy

50
Q

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

A

18 months

51
Q

what phase is post marketing studies

A

4

52
Q

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
A

2

53
Q

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

A

T

54
Q

the FDA considers 2 products bioeq if

A

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

55
Q

why is 80-125% considered bioeq?

A

arbitrary

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

56
Q

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

A

relative

57
Q

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

A

absolute

Y2S1 302 (10 decks)

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