module 17 drug regulation and monitoring Flashcards Preview

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Flashcards in module 17 drug regulation and monitoring Deck (18)
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1
Q

FDA and CDER

A

protect public health by assuring the safety, efficacy, and security of drugs

2
Q

drug discovery

A

2-5 years
compound identification and optimization
patent application

3
Q

drug development

A
5-9 years
biological characterization of drug 
patent granted 
toxicology studies 
IND filed
- phase 1 and 2 trials 
-- end phase 2 meeting
---- phase 3 trials 
----- NDA filed 
------ FDA approval 
develop manufacturing
4
Q

post-approval regulation

A

phase IV
ANDA filed
patent expires -> generics made available

5
Q

phase 1 trials

A
small scale: 20-80
healthy volunteers 
est. safety and tolerability 
focus overall includes dosing and PK parameters 
often non-blinded
6
Q

phase 2 trials

A
dose selection 
efficacy
inc. number people 50-300
effectiveness of drug for particular disease
detecting adverse events
single blind trial
7
Q

phase 3 trials

A

large scale: 300-3000
clinical or surrogate endpoints
employ randomization, controlled, double-blind trials
results should typically provide adequate basis for extrapolating results to general pop.

8
Q

preclinical research: purpose and methods

A

show that the drug is reasonable and safe

  • data from in vitro or animal studies
  • design studies to provide evidence necessary for administering the compounds to humans
  • investigations on absorption and metabolism
  • toxicity of drug metabolites
  • speed of excretion
  • 2 or more species tested
9
Q

preclinical research: animal testing

A

short-term: 2weeks-3mo.
long-term: few weeks to several years
- control group or placebo
- compare to current drug

10
Q

investigational new drug (IND) application

A

sponsor submits info to FDA who reviews and decided to continue to human trials or not.
- know bias: placebo and drug must look same

11
Q

ethics in clinical drug investigation

A
  • must minimize the risk for participants
  • provisions must be made for overall care of pt
  • investigator responsible for terminating the trial when risk becomes higher than benefit
  • adverse events must be reported immediately to ethics committee
  • data and safety monitoring board reviews safety and efficacy data
12
Q

institutional review boards

A

used to ensure the rights and welfare of people participating in trials

13
Q

clinical trial design must consider and answer

A
  • which prospectively defined outcome variables are feasible to measure and scientifically valid
  • whether a control group is possible and what tx to use in control group, if any
  • ease with which subjects and investigators may be blinded
  • definition and scope of disease
  • number of participating trial sites and pts
14
Q

New drug application (NDA)

A

from clinical trails -> selling
must provide following info
- drug is safe and effective for proposed use
- drugs proposed labeling is appropriate
- methods used in manufacturing the drug and the control used maintain the drugs quality are adequate to preserve the drugs identity, strength, quality, and purity.

15
Q

fast track status

A

accelerated development and approval status for serious and life-threatening disease

16
Q

orphan drug

A

drug for a disease that affects <200,000 people in the US

17
Q

generic drug approval

A

contain the same active ingredients as brand
be identical in strength, dose, and route of admin
have the same use indications
be bioequivalent
meet the same batch requirements
be manufactured under the same strict standards

18
Q

phase 4 studies

A

post-drug approval
more info about the side effects and safety of the drug when used in general population
long term risks and benefits
efficacy when used in the general population

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