Which of the following answers is correct?
The NOAEL is defined as the highest dose at which no clinical and/or biological relevant adverse effect is observed in preclinical toxicology studies
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
The following are true about the early stages of schizophrenia: (more than one answer might be correct)
Attention deficits may be present
Motor dysfunction is an early warning sign.
Medical interventions prior to the first psychotic symptoms may be more effective
Brain structure that is clearly different from healthy individuals
Mild or moderate disturbance in language.
Schizophrenia is a genetic disorder,
but it is not heritable
and its heritability is around 80%.
and environmental factors are not important.
and its heritability is around 10%.
but genetics factors are not associated with schizophrenia symptoms
What types of bias affect the "internal validity" of a study? (several answers are correct)
selection bias (creating groups with different confounders; solved by randomization)
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)
attrition bias (dropout of subjects with a negative outcome not included in the final result)
Which brain function is dominated most by one hemisphere?
Hearing
Smelling
Language
Memory
Vision
Which of these anatomic structures is not part of the basal ganglia?
Corpus striatum
Red nucleus
Subthalamic nucleus
Caudate nucleus
A meta-analysis is a study that
retrospectively combines all trials performed by one group
eliminates the bias introduced by studies of low quality
can only be performed when more than 10 trials have been performed
is a prospective trial of study quality
none of the above
Which study(ies) belong(s) to Phase I? (more than one answer might be correct
Bioequivalence
First in Human
Pharmacokinetics in renal impairment
Proof of concept
Pharmacokinetic drug interaction
What has the neurotransmitter dopamine been shown to encode?
stop signals
reward signals
fear signals
motor signals
Which answer is incorrect? Risk factors for schizophrenia include:
Weight gain
Influenza infection during pregnancy
Toxoplasmosis gondii
Age of father at conception
High expressed emotions families
What is the main advantage of bipolar electrophysiological recordings, compared to a common reference?
better spectral resolution
better time resolution
better spatial resolution
higher amplification
Which of the following statements is correct?
A SUE is always related to the administration of the test substance
A SUSAR can be a serious or a non-serious adverse reaction
A SUSAR should be reported to Ethic Committee and Health Authorities
The attrition (=failure) rate from first in man to registration of a drug in medicine is typically ...
50%
90%
20 %
30%
E. 99%
What are the legal preconditions for the conduct of a clinical study? (more than one answer is correct)
IRB approval
Insurance Certificate
Data protection approval
Youth welfare office approval
Study bank account
The first dose in humans is equivalent to NOAEL
The first dose in humans is a fraction of NOAEL
The first dose in humans is higher than NOAEL
Ownership of intellectual property in academic research in Germany and the US is held by
the inventor(s)
the funding agency
the University
Researcher(s) who are not employed by the University but inventor(s)
the University Researcher(s) who are not employed by the University but inventor(s)
Which of the following statements is true regarding the striatum? (more than one answer is correct)
receives inhibitory input from the cortex
consists of the lenticular nucleus and the putamen
receives dopaminergic input from the substantia nigra pars compacta
contains cells that use acetylcholine as their transmitter
all of the above statements are true
Which other description of the clinical symptom chorea is correct?
Babinski sign
akinesia
rigidity
uncontrollable involuntary movement
spasticity
The primary outcome of a First-in-Human study is always:
Safety and tolerability
Feasibility
Pharmacodynamics
Therapeutic effect
