16: Regulatory Science Flashcards
in terms of health care costs, what gets more spending, maintenance of good health or treating late stage diseases
treating late stage diseases
4 steps in the process of discovery
basic research
translational research
applied research
apply to consumers for cures, treatments, and prevention
sources of new drugs may come from
new chemical entity by organic synthesis
lead compound modifications to already existing compounds
natural sources like plants and animals
genetic developments
3 aspects of the genetic field of drug development
recombinant DNA
monoclonal antibodies
human gene therapy
_________ 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
recombinant DNA
what kind of genetics based drugs can be used to detect HCG
monoclonal antibody
what is included in the research and development stage of drug development
finding intrinsic dissolution, solubility, physiochemical properties, etc
what is the last step in the early development of drugs
provisional BCS classification
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
fugacity
liquid crystal ____ ratio may be used as a surrogate parameter for intestinal permeability
fugacity
when there is a health claim, the product must be a ____ or ____
NHP or non-Rx drug
______: use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms
drugs
define a NHP
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.
what medications are suitable for self care
non-Rx
what are not NHPs
schedule 2 excluded substances like radiopharmaceuticals and biologics
main factors for determining if a product is a NHP, non-Rx, or cosmetic
presence of health claim
ingredients
how many years on average, from early lab testing, does it take for a new drug to be approved for general public
8-9 years
what are INDs
investigational new drug
T or F: a IND only includes small molecule drugs, not biological products
F- includes biological products used in vitro for diagnostic purposes
tendency of a substance to prefer one phase over another
fugacity
octanol fugacity is a surrogate for
membrane permeability
food and drugs act catagories
medical cannabis regulation food and drug regulations medical devices regulations NHP regulations cosmetics regulations
what regulatory framework applies to health products in canada with one set of regulations for food and drugs and one for natural health products
food and drug act
the food and drugs act has one set of regulations for _______ and one for ________
food and drugs
NHPs
T or F: NHPs are not suitable for self care and require pharmacist intervention
F- suitable
\ a company wants to market a popular herbal remedy as a IM shot. Would it be classified as a NHP ?
no. NHP can’t be administered by puncturing skin
T or F: certain antibiotics are NHP
F
anything on schedule 2 is
- okay for self directed use
- a NHP
- excluded substances to NHPs
- prescription medication
3
what is schedule 1
- NHPs
- parenteral adminstered meds
- substances under the tobacco act
- antibiotics
1
a toothpaste with fluoride is considered a
- cosmetic
- NHP
- non-Rx drug
- Rx- drug
- 2 and 3
5
toothpaste without fluoride is considered a
- cosmetic
- NHP
- non-Rx drug
- Rx- drug
- 2 and 3
1
______ can not include claims about your health
- cosmetic
- NHP
- non-Rx drug
- Rx- drug
- 2 and 3
1
antiperspirants, under health canada, are considered
- NHP
- non-Rx
- cosmetics
1
the USA has _____ while canada has _______ for trialing new drugs
USA = investigational new drug application (IND) canada = clinical trial application phases 1, 2, 3
goal at the end of phase 3 clinical trials for USA = _________, canada __________
USA = new drug application (NDA) canada = new drug submission
before an IND, the sponsor must first submit data showing that the drug is ________ for use in initial, ________
reasonably safe
small scale clinical studies
what options do researchers have for showing the drug is safe for use in initial studies
compiling existing nonclinical data
previous clinical data
new preclinical data
tests performed before IND
genotoxicity
ADMA investigations
toxicity of metabolites
what are 3 things, at minimum, the FDA will ask the sponsor to provide at the preclinical stage
pharmacological profile of drug
determine acute toxicity in at least 2 species of animals
conduct short term studies of 2wks-3months
in animal testing, generally how many species are needed
2 or more
______ represent the ultimate premarket testing ground for unapproved drugs
clinical trials
what is the single most important factor in approval/ disapproval of a new drug
clinical trial results
what phase of clinical trials looks at structure activity relationships
phase 1
what phase of trials looks for therapeutic windows
phase 2
T or F: early evidence of effectiveness may be gained in phase 1
T
what is the purposes of a clinical hold
so the CDER can stop a trial if safety or other factors were not disclosed and cause risk
in what phase of clinical trials do we first see patients with the disease we want to treat
phase 2
what phase is done to evaluate the overall benefit risk relationship of a drug to provide info for physician labeling
phase 3
what is an uncontrolled trial
no participants taking placebo/ alternate therapy
what is the average time to process a review for a new drug (After clinical trials are completed)
18 months
what phase is post marketing studies
4
which of the following is true for biosimilar drugs
- it relies on new information about safety, efficacy and effectiveness
- is a biologic that gets market authorization after a version prev authorized in canada + demonstrates similarity to the reference product
- previously referred to as subsequent reference biologics
2
T or F: all gennerics sold in canada must be made in canada
T
the FDA considers 2 products bioeq if
90% CI of the relative mean Cmax, AUC of comparing test to reference is within 80-125% in the fasting state
why is 80-125% considered bioeq?
arbitrary
not 80-120% because PK parameters for exposure (AUC and Cmax) are log distributed
______ bioavailability is reported when the product is an oral solution of an oral solid dosage form
relative
_____ bioavailability is reported when the reference product is an IV dosage form
absolute
