BIOSTAT LECOM Test 1 Questions & Answers 2024/2025
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BIOSTAT LECOM
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BIOSTAT LECOM
BIOSTAT LECOM Test 1 Questions & Answers 2024/2025
Define NDA - ANSWERSNew Drug Application
Define IND - ANSWERSInvestigational New Drug Application
What are the steps for drugs development? - ANSWERS-Molecules are found for drug creation
-Pre-Clinical Trials
-IND submitted
-Clinical ...
BIOSTAT LECOM Test 1 Questions &
Answers 2024/2025
Define NDA - ANSWERSNew Drug Application
Define IND - ANSWERSInvestigational 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? - ANSWERSTesting of drug safety and drug data in
animals
What is Phase 1 in Drug Development? - ANSWERSChemistry 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? - ANSWERSA 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? - ANSWERSRCT (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? - ANSWERSDrug 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? - ANSWERSWithdrawal/discontinuation of drug
Identify where in the Drug Discovery Process human studies begin. - ANSWERSAfter receipt of the IND
application.
Which Phases of clinical trials examine pharmacokinetic and pharmacodynamics using health
volunteers? - ANSWERSPhase 1
Which Phase of Clinical Trials requires at least one large randomized controlled trial? - ANSWERSPhase 3
Pharmacovigilance is conducted in which phase? - ANSWERSPhase 4
The "outcome" variable is also known as what? - ANSWERSDependent Variable
Which axis are independent variables? - ANSWERSHorizontal and x-axis
Which axis are dependent variables? - ANSWERSVertical and y-axis
Would Height be considered dependent or independent Variable? - ANSWERSIndependent
Would Blood Pressure be considered dependent or independent variable? - ANSWERSDependent
Independent Variables can quite often be what kind of variable? - ANSWERSNominal
Dependent variables can quite often be what kind of variables? - ANSWERSRatios
What are the two classes of Variables? - ANSWERS-Discrete (categorical)
-continuous (# line)
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