(20 Fragen mit jeweils
a) und b), 45 Minuten Zeit, Multiple Choice, englisch)
10 Tiere sterben in präklinischer Studie aus Gründen, die nichts mit der
Testsubstanz zu tun haben, muss ich dokumentieren? (ja)
- rough design first in man (FIM)
- ICH S7A,
core battery for which organ systems
- how to perform an integrated risk assessment
- basic role of HERG channel
- membrane potential: by which ion species
- definition of cardiac output
-
preferred animal species for QT measurement
- basic design of TQT study
- mechanism for some common drugs (for better mood)
- CNS core
battery: which studies
- animal models for drug dependency
- drugs that effect the respiratory system
- parameters tested for RS
- what kind of effects cannot be detected my measuring
ventilation parameters
- when should studies be performed
- frequent GI system-related side effects
- markers for tubular damage
- markers for nephron damage
- drugs that induce acute kidney damage
- basic scope of ICHS9
- hERG channel evaluation of
antibodies
- definition circardian
rhythm/biological rhythm
- location of master clock
(Multiple Choice, 43 Fragen unter Angabe wie viele richtige Antworten, Gruppe A und B mit gleichen Fragen aber unterschiedlicher Reihenfolge, 45 Minuten Zeit, Englisch)
- activities not done in P0/PI
- what to be performed before Phase 0/1 in drug development
process
- tox studies needed for first into
man (FIM) (SP, Genotox, General Tox)
- what is required in guideline of Safety Pharmacology
- when can a waiver be applied for ICS S7A
- ICH
S7B, which assays for nonclinical methodologies
- ICH
S9, under which conditions = waivers
- ions responsible for upstroke of action potential during
depolarization (Na+)
- mechanism/function of Ca2+ during contraction (ca induced Ca
release, cellular contraction)
- definition/formula for cardiac output (stroke volume x heart
rate)
- major function to be maintained by CV system (blood
pressure, brain perfusion)
- in vivo CV animal model: when anesthetized animals useful
(when high dose required)
- not suitable animal species for CV (mouse, rat)
- pacemaker heart (sinus node)
- different statements regarding arrhythmias (to be judged
corrector not)
- TQT
study, when positive
- TQT
study, positive control use (moxifloxaxin)
- female, higher risk for TdP
- drugs acting on the glutamatergic receptor/neurotransmission
(Memantine, Phencyclidine)
- mechanism of action for cocaine
- animal models to investigate drug dependency potential
(withdrawal, self administration/place preference,
drug discrimination)
- CNS-core
battery
- most frequent drug side effects (headache, dizziness)
- location of respiratory center in brain (brain stem)
- characteristics/function of alveoli, impairment in COPD
- definition Tidal Volume
- which animal models for nausea (gastric emptying, gastric
secretion)
- effect of different drugs on GI function
- ferret and dogs as animal models for GI side effects
- use of ussing chamber
- endpoints of studies, differences safety pharmacology vs. tox studies (in SP – endpoints are on day 1)
- SP
studies for biologics, requirement/waiver
- kidney, main function/effect of kidney on drugs
- kidney, drugs with acute effects on (Gentamicin, Formoterol)
- hERG assay requirement for
biologics
- ICH
S9 guideline, scope
- risk assessment, definition of NOAEL
- risk assessment, what to consider (specificity, sensitivity,
predictivity of applied models)
- GLP,
responsibility for GLP compliance of test facility (facility management)
- GLP,
10 animals in control group died, documentation (yes)
- GLP,
during ongoing study decision to take additional plasma samples, how to
document (study plan amendment before plasma samples)
- chronobiology, circadian rhythm, biological rhythm, location
of master clock, effect on food uptake, effect on drug PK
- case
study, proceed into FIM although some SP findings (yes, if safe starting dose
and stopping criteria)
- Definition
therapeutic index
- QT
related questions – true or false? (one statement – QT
changes temperature sensitive – only in minipigs? –
No)
- what effects does Calcium trigger
- what assays are used to assess ion channel activities
- what CV-endpoints can be established in studies of Safety
Pharmacology
- what and in what priorities are different parts maintained
stable by the cardiovascular system
- advantages/disadvantages of different models and in what
situations one preferred over another
- what is the main pacemaker in heart tissue
- the definition of a valid QT-study
- what compound is used in CV-studies as positive control
- how does the QT and following consequences of females differ
from the one of males
- what is to be assessed in the CNS-studies
- how is drug interaction assessed in CNS-studies
- function
of cocaine, amphetamines, "angel dust"
- what are additional CNS studies
- most frequent diseases in new drugs
- where (in body) is respiration controlled
- typical respiration diseases
- main functions of kidney
- GI-models
for nausea
- timing in achieving endpoints in contrast to typical tox-studies
- relevance of hERG-assays in
oncology
- how does regulation and studies for oncology-drugs differ
- who is responsible for GLP compliance of testing facility
- not-item
related death in a study – to be documented? when in
process of study/study report etc.
- change in study-program (change of day of analysis due to
first analytic results) - – to be documented? when in
process of study/study report etc.? Who is to be informed?
- definition of therapeutic index
Aus ca 45 Multiple Choice Fragen
zu Safety Pharmacology in
Basel 2017: Viele Fragen bestanden aus 3-5 Aussagen und man musste die
richtigen ankreuzen bzw. welche Kombination richtig ist. Es wurde immer
angegeben, wie viele man ankreuzen muss.
What is the
mechanism of cocaine in the synapse?
Which amino
acid is needed to synthesize dopamine?
How large
is the tidal volume of humans in mL?
What has to
be tested according to ICH S7A for CNS?
What apart
from drugs can affect the QT?
Which
species is used for in vivo CV studies?
Who signs
the quality assurance (GLP)?
What has to
be done, if 10 animals die non-drug related in a study (GLP)?
Kim1 is a
kidney injury marker for which part (possible answers: glomerulus, proximal
tubule...)?
What
controls the respiratory activity?
Which
tissue is the main pace maker of the heart?
Which
organisms have circadian rhythms?
When is the
cortisol concentration the highest in humans?
Night and day active species?
Do
circadian rhythms influence in vivo study results?
Can the
magnitude of toxic effects be influenced by circadian rhythms?
Nocturnal
dippers
Which
species are used nausea testing?
According
to ICH S9, under which conditions no stand alone
safety pharm is needed?
Definitions
of tidal volume, cardiac output, minute volume,
Correction
of QT ( how? Quality control?
For every species the same formula?)
What leads
to vasodilation?
A substance
accumulates in the heart during repeated dosing. How should the safety pharm
study be designed?
On which
days after dosing are endpoints measured in Safety pharmacology?
In which
phase (1-4) takes the QT prolongation place? (question
was difficult to understand)
Which
assays measure the functionality of ion channels?
Which ion
channel is investigated? (K, Na, Ca?)
A safety
pharm study is integrated in a repeated dose tox
study. Does it matter if the safety pharm endpoints are measured after the
first dose or can it also be done after another dosing?
Neue Fragen? Dann maile sie sofort an herbsjo1@gmx.de
E-Mail bitte deutlich
schreiben. Ich bin Brillenträger!
Last Update: 17. April 2017