BIOSTAT TEST 1 LECOM QUESTIONS
AND ANSWERS
Define NDA - Correct Answers -New Drug Application
Define IND - Correct Answers -Investigational New Drug Application
What are the steps for drugs development? - Correct Answers --Molecules are found for
drug creation
-Pre-Clinical Trials
-IND submitted
-Clinical Trials (phases 1-3)
-NDA Submitted
-FDA Review & Approval
-Phase 4
What are Pre-Clinical trials in drug development? - Correct Answers -Testing of drug
safety and drug data in animals
What is Phase 1 in Drug Development? - Correct Answers -Chemistry of the drug is
tested in small group of healthy volunteers (tens). Provides the findings of maximum
tolerable dose.
What is Phase 2 in Drug Development? - Correct Answers -A group of a couple of
hundred people with disease or symptoms of disease to see effectiveness and to find
side-effects in drug. Also known as Pilot testing
What is Phase 3 in Drug development? - Correct Answers -RCT (Randomized Control
Testing). Drug given to thousands of patients with disease to see overall risks and
benefits. Use of placebo testing.
What is Phase 4 in Drug development? - Correct Answers -Drug is released to the open
world of people and is then tracked to find any risks and side-effects that were not
shown in trial known as black box warnings.
If a drug fails its Phase 4 stage what can occur? - Correct Answers
-Withdrawal/discontinuation of drug
Identify where in the Drug Discovery Process human studies begin. - Correct Answers -
After receipt of the IND application.
, Which Phases of clinical trials examine pharmacokinetic and pharmacodynamics using
health volunteers? - Correct Answers -Phase 1
Which Phase of Clinical Trials requires at least one large randomized controlled trial? -
Correct Answers -Phase 3
Pharmacovigilance is conducted in which phase? - Correct Answers -Phase 4
The "outcome" variable is also known as what? - Correct Answers -Dependent Variable
Which axis are independent variables? - Correct Answers -Horizontal and x-axis
Which axis are dependent variables? - Correct Answers -Vertical and y-axis
Would Height be considered dependent or independent Variable? - Correct Answers -
Independent
Would Blood Pressure be considered dependent or independent variable? - Correct
Answers -Dependent
Independent Variables can quite often be what kind of variable? - Correct Answers -
Nominal
Dependent variables can quite often be what kind of variables? - Correct Answers -
Ratios
What are the two classes of Variables? - Correct Answers --Discrete (categorical)
-continuous (# line)
What are discrete variables? - Correct Answers -Nominal and Ordinal
What are continuous variables? - Correct Answers -Interval and ratio
What are Nominals? - Correct Answers -Just a name; example: eye color. Not
changeable
What is Ordinal? - Correct Answers -A name with an order such as a number line.
Subject is able to change because of no objectivity.
What is an Interval? - Correct Answers -Name that can be above or below 0. No true 0.
Example: change in systolic HBP. Only can be addition and subtraction.
What is a Ratio? - Correct Answers -Must be a true 0. Can only be positive. A name that
cannot be below 0.
AND ANSWERS
Define NDA - Correct Answers -New Drug Application
Define IND - Correct Answers -Investigational New Drug Application
What are the steps for drugs development? - Correct Answers --Molecules are found for
drug creation
-Pre-Clinical Trials
-IND submitted
-Clinical Trials (phases 1-3)
-NDA Submitted
-FDA Review & Approval
-Phase 4
What are Pre-Clinical trials in drug development? - Correct Answers -Testing of drug
safety and drug data in animals
What is Phase 1 in Drug Development? - Correct Answers -Chemistry of the drug is
tested in small group of healthy volunteers (tens). Provides the findings of maximum
tolerable dose.
What is Phase 2 in Drug Development? - Correct Answers -A group of a couple of
hundred people with disease or symptoms of disease to see effectiveness and to find
side-effects in drug. Also known as Pilot testing
What is Phase 3 in Drug development? - Correct Answers -RCT (Randomized Control
Testing). Drug given to thousands of patients with disease to see overall risks and
benefits. Use of placebo testing.
What is Phase 4 in Drug development? - Correct Answers -Drug is released to the open
world of people and is then tracked to find any risks and side-effects that were not
shown in trial known as black box warnings.
If a drug fails its Phase 4 stage what can occur? - Correct Answers
-Withdrawal/discontinuation of drug
Identify where in the Drug Discovery Process human studies begin. - Correct Answers -
After receipt of the IND application.
, Which Phases of clinical trials examine pharmacokinetic and pharmacodynamics using
health volunteers? - Correct Answers -Phase 1
Which Phase of Clinical Trials requires at least one large randomized controlled trial? -
Correct Answers -Phase 3
Pharmacovigilance is conducted in which phase? - Correct Answers -Phase 4
The "outcome" variable is also known as what? - Correct Answers -Dependent Variable
Which axis are independent variables? - Correct Answers -Horizontal and x-axis
Which axis are dependent variables? - Correct Answers -Vertical and y-axis
Would Height be considered dependent or independent Variable? - Correct Answers -
Independent
Would Blood Pressure be considered dependent or independent variable? - Correct
Answers -Dependent
Independent Variables can quite often be what kind of variable? - Correct Answers -
Nominal
Dependent variables can quite often be what kind of variables? - Correct Answers -
Ratios
What are the two classes of Variables? - Correct Answers --Discrete (categorical)
-continuous (# line)
What are discrete variables? - Correct Answers -Nominal and Ordinal
What are continuous variables? - Correct Answers -Interval and ratio
What are Nominals? - Correct Answers -Just a name; example: eye color. Not
changeable
What is Ordinal? - Correct Answers -A name with an order such as a number line.
Subject is able to change because of no objectivity.
What is an Interval? - Correct Answers -Name that can be above or below 0. No true 0.
Example: change in systolic HBP. Only can be addition and subtraction.
What is a Ratio? - Correct Answers -Must be a true 0. Can only be positive. A name that
cannot be below 0.
