BIOSTAT TEST 1 LECOM QUESTIONS WITH CORRECT ANSWERS LATEST UPDATE
2025/2026
Define NDA - Answers New Drug Application
Define IND - Answers Investigational New Drug Application
What are the steps for drugs development? - 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? - Answers Testing of drug safety and drug data
in animals
What is Phase 1 in Drug Development? - 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? - 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? - 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? - 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? - Answers Withdrawal/discontinuation of drug
Identify where in the Drug Discovery Process human studies begin. - Answers After receipt of
the IND application.
Which Phases of clinical trials examine pharmacokinetic and pharmacodynamics using health
volunteers? - Answers Phase 1
Which Phase of Clinical Trials requires at least one large randomized controlled trial? - Answers
, Phase 3
Pharmacovigilance is conducted in which phase? - Answers Phase 4
The "outcome" variable is also known as what? - Answers Dependent Variable
Which axis are independent variables? - Answers Horizontal and x-axis
Which axis are dependent variables? - Answers Vertical and y-axis
Would Height be considered dependent or independent Variable? - Answers Independent
Would Blood Pressure be considered dependent or independent variable? - Answers Dependent
Independent Variables can quite often be what kind of variable? - Answers Nominal
Dependent variables can quite often be what kind of variables? - Answers Ratios
What are the two classes of Variables? - Answers -Discrete (categorical)
-continuous (# line)
What are discrete variables? - Answers Nominal and Ordinal
What are continuous variables? - Answers Interval and ratio
What are Nominals? - Answers Just a name; example: eye color. Not changeable
What is Ordinal? - Answers A name with an order such as a number line. Subject is able to
change because of no objectivity.
What is an Interval? - 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? - Answers Must be a true 0. Can only be positive. A name that cannot be below
0.
Mitchell Marner of Toronto Maple Leafs Hockey Club wears number 16. What type of Variable is
16? - Answers Nominal
On January 11, 2015, The temperature in Erie, PA was 16 degrees. What type of Variable is 16? -
Answers Interval
In a Parametric distribution, which measurements are all approx. equal? - Answers Mean,
median, mode
The interquartile range is defined by what? - Answers 25th to the 75th percentile.
What are the measurements of the middle? - Answers Mean, Median, Mode
2025/2026
Define NDA - Answers New Drug Application
Define IND - Answers Investigational New Drug Application
What are the steps for drugs development? - 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? - Answers Testing of drug safety and drug data
in animals
What is Phase 1 in Drug Development? - 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? - 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? - 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? - 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? - Answers Withdrawal/discontinuation of drug
Identify where in the Drug Discovery Process human studies begin. - Answers After receipt of
the IND application.
Which Phases of clinical trials examine pharmacokinetic and pharmacodynamics using health
volunteers? - Answers Phase 1
Which Phase of Clinical Trials requires at least one large randomized controlled trial? - Answers
, Phase 3
Pharmacovigilance is conducted in which phase? - Answers Phase 4
The "outcome" variable is also known as what? - Answers Dependent Variable
Which axis are independent variables? - Answers Horizontal and x-axis
Which axis are dependent variables? - Answers Vertical and y-axis
Would Height be considered dependent or independent Variable? - Answers Independent
Would Blood Pressure be considered dependent or independent variable? - Answers Dependent
Independent Variables can quite often be what kind of variable? - Answers Nominal
Dependent variables can quite often be what kind of variables? - Answers Ratios
What are the two classes of Variables? - Answers -Discrete (categorical)
-continuous (# line)
What are discrete variables? - Answers Nominal and Ordinal
What are continuous variables? - Answers Interval and ratio
What are Nominals? - Answers Just a name; example: eye color. Not changeable
What is Ordinal? - Answers A name with an order such as a number line. Subject is able to
change because of no objectivity.
What is an Interval? - 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? - Answers Must be a true 0. Can only be positive. A name that cannot be below
0.
Mitchell Marner of Toronto Maple Leafs Hockey Club wears number 16. What type of Variable is
16? - Answers Nominal
On January 11, 2015, The temperature in Erie, PA was 16 degrees. What type of Variable is 16? -
Answers Interval
In a Parametric distribution, which measurements are all approx. equal? - Answers Mean,
median, mode
The interquartile range is defined by what? - Answers 25th to the 75th percentile.
What are the measurements of the middle? - Answers Mean, Median, Mode
