|
71 |
Role-play.
|
|
72 |
Viva. |
|
73 |
Viva. |
|
74 |
Viva. |
|
75 |
EMQ. Fezolinetant |
71. Role-play. Candidate’s
instructions will be will be emailed shortly before the tutorial.
72
- 74. Viva. Topics will be revealed during the tutorial so that you
can’t prepare!
75. Fezolinetant & the SKYLIGHT trials. EMQ. Questions.
Abbreviations.
FDA: US Food & Drug Administration.
Please attempt to answer without
preparation – that is what you have to do in the exam.
Question
1.
Which of the following drugs featured in the SKYLIGHT series of trials
and led to it
being approved for use by the FDA in
2023?
|
A |
Fezofez |
|
B |
Fezolift |
|
C |
Fezolinetant |
|
D |
Fezolineout |
|
E |
Fezolineup |
|
F |
none of
the above |
Question
2.
What kind of drug is it?
|
A |
GnRH
analogue |
|
B |
hair
restorer |
|
C |
synthetic
dynorphin |
|
D |
synthetic
kisspeptin |
|
E |
synthetic
neurokinin |
|
F |
|
|
G |
neurokinin
3 receptor antagonist |
|
H |
none of
the above |
Question
3.
What is it used for?
|
A |
Fragile
X syndrome |
|
B |
male-pattern
baldness |
|
C |
menopausal
vasomotor symptoms |
|
D |
migraine |
|
E |
premature
ovarian insufficiency |
|
F |
recurrent
miscarriage |
|
G |
none of
the above |
Question
4.
What side effects have been attributed to its use?
|
A |
acne |
|
B |
alopecia
|
|
C |
asthma |
|
D |
depression |
|
E |
diarrhoea |
|
F |
impaired
memory |
|
G |
insomnia |
Question
5.
What is the situation re its use in the NHS?
|
A |
it is
licensed for use in the NHS |
|
B |
NICE has
not approved its use because of its high cost |
|
C |
NICE has
not approved its use because of concerns re side-effects v benefits |
|
D |
NICE is
due to start appraising fezolinetant in July 2024 |
|
E |
none of
the above |
Question
6. Which, if any, of the following are
correct about the warning issued by the FDA in
September
2024?
|
A |
10 cases
of severe liver damage occurred within 2 months of starting Fzo |
|
B |
10 cases
of severe renal damage occurred within 2 months of starting Fzo |
|
C |
regular
liver function tests should be done for 9 months |
|
D |
regular
renal function tests should be done for 9 months |
|
E |
Fzo
should no longer be prescribed |
|
F |
none of
the above |
Question 7.
Which, if any, of the following are correct about the Highlight1 trial?
|
A |
it
compares FZO with E2 patches in relief of VMS in menopausal women
age > 50 |
|
B |
it
compares FZO with E2 patches in relief of VMS in menopausal women
age > 60 |
|
C |
it
compares FZO with E2 patches in relief of VMS in women with POI |
|
D |
it
compares FZO with E2 patches in relief of VMS in women with breast
Ca |
|
E |
it
compares FZO with placebo patches in relief of VMS in women with breast Ca |
|
F |
it is a
Phase 4 trial. |
|
G |
none of
the above |
Question 8.
Which, if any, of the following are correct about the phases of clinical
trials?
|
A |
a Phase
0 trial uses the new Rx at low doses to check safety |
|
B |
a Phase 1
trial attempts to assess what effects the new Rx has |
|
C |
a Phase
2 trial usually involves up to 100 individuals as guinea pigs |
|
D |
a Phase
3 trial compares the new Rx with existing regimes for efficacy |
|
E |
a Phase
5 trial compares the cost of the new Rx with the standard treatment |
|
F |
none of
the above |
No comments:
Post a Comment