BioStat Test 1 LECOM| Questions with
Solutions
Define NDA - - New Drug Application
- Define IND - - Investigational New Drug Application
- What are the steps for drugs development? - - -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? - - Testing of drug safety
and drug data in animals
- What is Phase 1 in Drug Development? - - 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? - - 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? - - 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? - - 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? - -
Withdrawal/discontinuation of drug
- Identify where in the Drug Discovery Process human studies begin. - -
After receipt of the IND application.
- Which Phases of clinical trials examine pharmacokinetic and
pharmacodynamics using health volunteers? - - Phase 1
, - Which Phase of Clinical Trials requires at least one large randomized
controlled trial? - - Phase 3
- Pharmacovigilance is conducted in which phase? - - Phase 4
- The "outcome" variable is also known as what? - - Dependent Variable
- Which axis are independent variables? - - Horizontal and x-axis
- Which axis are dependent variables? - - Vertical and y-axis
- Would Height be considered dependent or independent Variable? - -
Independent
- Would Blood Pressure be considered dependent or independent variable? -
- Dependent
- Independent Variables can quite often be what kind of variable? - -
Nominal
- Dependent variables can quite often be what kind of variables? - - Ratios
- What are the two classes of Variables? - - -Discrete (categorical)
-continuous (# line)
- What are discrete variables? - - Nominal and Ordinal
- What are continuous variables? - - Interval and ratio
- What are Nominals? - - Just a name; example: eye color. Not changeable
- What is Ordinal? - - A name with an order such as a number line. Subject is
able to change because of no objectivity.
- What is an Interval? - - 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? - - 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? - - Nominal
- On January 11, 2015, The temperature in Erie, PA was 16 degrees. What
type of Variable is 16? - - Interval
Solutions
Define NDA - - New Drug Application
- Define IND - - Investigational New Drug Application
- What are the steps for drugs development? - - -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? - - Testing of drug safety
and drug data in animals
- What is Phase 1 in Drug Development? - - 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? - - 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? - - 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? - - 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? - -
Withdrawal/discontinuation of drug
- Identify where in the Drug Discovery Process human studies begin. - -
After receipt of the IND application.
- Which Phases of clinical trials examine pharmacokinetic and
pharmacodynamics using health volunteers? - - Phase 1
, - Which Phase of Clinical Trials requires at least one large randomized
controlled trial? - - Phase 3
- Pharmacovigilance is conducted in which phase? - - Phase 4
- The "outcome" variable is also known as what? - - Dependent Variable
- Which axis are independent variables? - - Horizontal and x-axis
- Which axis are dependent variables? - - Vertical and y-axis
- Would Height be considered dependent or independent Variable? - -
Independent
- Would Blood Pressure be considered dependent or independent variable? -
- Dependent
- Independent Variables can quite often be what kind of variable? - -
Nominal
- Dependent variables can quite often be what kind of variables? - - Ratios
- What are the two classes of Variables? - - -Discrete (categorical)
-continuous (# line)
- What are discrete variables? - - Nominal and Ordinal
- What are continuous variables? - - Interval and ratio
- What are Nominals? - - Just a name; example: eye color. Not changeable
- What is Ordinal? - - A name with an order such as a number line. Subject is
able to change because of no objectivity.
- What is an Interval? - - 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? - - 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? - - Nominal
- On January 11, 2015, The temperature in Erie, PA was 16 degrees. What
type of Variable is 16? - - Interval
