Question 1
Question
Which of the following answers is correct?
Answer
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The NOAEL is defined as the highest dose at which no clinical and/or biological relevant adverse effect is observed in preclinical toxicology studies
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The NOAEL is defined as the lowest dose at which at least one clinical and/or biological relevant adverse effect is observed in preclinical toxicology studies
Question 2
Question
The following are true about the early stages of schizophrenia: (more than one answer might be correct)
Answer
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Attention deficits may be present
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Motor dysfunction is an early warning sign.
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Medical interventions prior to the first psychotic symptoms may be more effective
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Brain structure that is clearly different from healthy individuals
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Mild or moderate disturbance in language.
Question 3
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Schizophrenia is a genetic disorder,
Answer
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but it is not heritable
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and its heritability is around 80%.
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and environmental factors are not important.
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and its heritability is around 10%.
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but genetics factors are not associated with schizophrenia symptoms
Question 4
Question
What types of bias affect the "internal validity" of a study? (several answers are correct)
Answer
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selection bias (creating groups with different confounders; solved by randomization)
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performance bias and detection bias (investigators respectively treating or assessing more positively those subjects on the treatment arm; controlled by blinding interventions and outcome assessments)
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attrition bias (dropout of subjects with a negative outcome not included in the final result)
Question 5
Question
Which brain function is dominated most by one hemisphere?
Answer
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Hearing
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Smelling
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Language
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Memory
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Vision
Question 6
Question
Which of these anatomic structures is not part of the basal ganglia?
Answer
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Corpus striatum
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Red nucleus
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Subthalamic nucleus
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Caudate nucleus
Question 7
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A meta-analysis is a study that
Answer
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retrospectively combines all trials performed by one group
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eliminates the bias introduced by studies of low quality
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can only be performed when more than 10 trials have been performed
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is a prospective trial of study quality
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none of the above
Question 8
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Which study(ies) belong(s) to Phase I? (more than one answer might be correct
Question 9
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What has the neurotransmitter dopamine been shown to encode?
Answer
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stop signals
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reward signals
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fear signals
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motor signals
Question 10
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Which answer is incorrect? Risk factors for schizophrenia include:
Answer
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Weight gain
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Influenza infection during pregnancy
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Toxoplasmosis gondii
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Age of father at conception
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High expressed emotions families
Question 11
Question
What is the main advantage of bipolar electrophysiological recordings, compared to a common reference?
Question 12
Question
Which of the following statements is correct?
Answer
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A SUE is always related to the administration of the test substance
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A SUSAR can be a serious or a non-serious adverse reaction
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A SUSAR should be reported to Ethic Committee and Health Authorities
Question 13
Question
The attrition (=failure) rate from first in man to registration of a drug in medicine is typically ...
Question 14
Question
What are the legal preconditions for the conduct of a clinical study? (more than one answer is correct)
Question 15
Question
Which of the following statements is correct?
Answer
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The first dose in humans is equivalent to NOAEL
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The first dose in humans is a fraction of NOAEL
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The first dose in humans is higher than NOAEL
Question 16
Question
Ownership of intellectual property in academic research in Germany and the US is held by
Question 17
Question
Which of the following statements is true regarding the striatum? (more than one answer is correct)
Answer
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receives inhibitory input from the cortex
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consists of the lenticular nucleus and the putamen
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receives dopaminergic input from the substantia nigra pars compacta
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contains cells that use acetylcholine as their transmitter
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all of the above statements are true
Question 18
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Which other description of the clinical symptom chorea is correct?
Question 19
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The primary outcome of a First-in-Human study is always:
Answer
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Safety and tolerability
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Feasibility
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Pharmacodynamics
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Therapeutic effect