Test1 Flashcards
Drug research standards in the US are set by
the FDA
What are EXCIPIENTS
non-essential ingredients in drugs
Why are EXCIPIENTS used
added to stabilize drugs, or to make them taste better, or to allay bacterial growth in medical applications
The IND application is
the Investigational New Drug application
What application does the FDA require prior to human testing during clinical trials
The IND application
Investigational New Drug
What does the IND application need to include
Values from initial testing, including:
drug composition,
manufacturing, &
plan for testing on humans.
Usually the IND application is approved by the FDA after ____ have passed.
30 days
After the _____ application is approved by the FDA, the first of 3 phases of clinical trials can begin.
IND
Investigational New Drug
____ is the emphasis of Phase I of clinical trials on human subjects.
Safety
______ and ____ effects and side effects of a drug are ascertained in Phase I of clinical trials on human subjects.
pharmacological & physiological
also how long it takes to be metabolized and excreted
____ is the emphasis of Phase II of clinical trials on human subjects.
Effectiveness (of the drug)
Comparing the effects of placebo versus drug is tested in Phase __ of clinical trials on human subjects.
II
The Drug Competition Action Plan was created by the ____ in 2017.
FDA
In Phase ___ clinical trials, volunteers are recruited in the thousands.
III
Drug interactions are determined in Phase __ clinical trials.
III
___ ____ are determined in Phase III clinical trials.
Drug interactions
as well as further evaluation of safety and effectiveness
________ studies requires finding healthy volunteers to demonstrate rate of absorption and excretion of compounds and excipients at the beginning of the clinical trials (and later for marketing).
Bioavailability
What is the NDA in clinical trials?
New Drug Application
After Phase ___ the NDA must be filed with the FDA.
IV
The NDA request includes
All Phase I - III information
Animal and human data
Analysis of the data
How the drug behaves in the body
Manufacturing process
Approximately half of drugs do not reach Phase ___
III
Why do approx. half of drugs do not reach Phase III?
Safety and efficacy
or
fail to meet financial criteria set by investors
A ____ formally asks for FDA approval to move a new drug to its commercial sale.
New Drug Application (NDA)
_____ applications are required to be passed prior to human testing during clinical trials.
Investigational New Drug (IND)
Phase __ studies can involve several hundred to several thousand subjects.
III
Late-phase drug development, especially in Phase ___ clinical trials and later efforts, can account for the majority of the costs of the process as a whole.
III
The IRB in clinical trials is composed of:
An independent board of
scientists, physicians, and nurses
who review the clinical trial protocol to ensure patient safety.
IRB in clinical trials stands for:
Institutional Review Board
