Question

What is the goal of a phase II clinical trial?

A. Demonstrate activity of the intervention.

B. Assess Drug-food interactions.

C. Determine the maximum tolerated dose.

D. Provide human pharmacokinetics data.

Answer #1

Phase II clinical trail is thestudy of Proof of Concept Trial/Study and Exploratory Trial/Study .

In this phase the Early evaluation of efficacy of drugs and the exploratory study to demonstrate the initial efficacy and safety by definitive end-points . In sort the evalution is take pass by the high dose of drug treatment and that dosage of drug doesn't cause any side effect that would not acceptable .

So, the most apt answer for this question is option (c) , determine the maximum tolerated dose .

Please prepare a brief description of the reasoning for
your choice of answer.
1)What is not typically measured during a Phase I clinical
trial?
a)The safety profile of the drug candidate when used in healthy
subjects
b)A clinical endpoint to estimate the drug’s candidates
effectiveness
c)The maximal tolerable dose of the drug candidate
d)The absorption, distribution, metabolic, and excretion
properties of a drug candidate
2)Which of the following is incorrect regarding the successful
completion of Phase III clinical trials?
a)Efficacy...

A clinical test on humans of a new drug is normally done in
three phases. Phase I is conducted with a relatively small number
of healthy volunteers. For example, a phase I test of a specific
drug involved only 8 subjects. Assume that we want to treat 8
healthy humans with this new drug and we have 13 suitable
volunteers available. Complete parts (a) through (c).
a. If the subjects are selected and treated in sequence, so
that the trial...

Please prepare a brief description of the reasoning
for your choice of answer.
1)Based on the structure of imatinib, describe the
physical and chemical properties that can account for it being
orally active?
2)What is not typically measured during a Phase I
clinical trial?
a)The safety profile of the drug candidate when used
in healthy subjects
b)A clinical endpoint to estimate the drug’s
candidates effectiveness
c)The maximal tolerable dose of the drug candidate
d)The absorption, distribution, metabolic, and
excretion properties...

A certain drug is used to treat asthma. In a clinical trial of
the drug, 20 of 265 treated subjects experienced headaches (based
on data from the manufacturer). The accompanying calculator display
shows results from a test of the claim that less than 9 % of
treated subjects experienced headaches. Use the normal distribution
as an approximate to the binomial distribution and assume a 0.05
significance level to complete parts (a) through (e) below.
a. Is the test two-tailed, left-tailed...

A certain drug is used
to treat asthma. In a clinical trial of the drug, 20 of 262
treated subjects experienced headaches (based on data from the
manufacturer). The accompanying calculator display shows results
from a test of the claim that less than 12% of treated subjects
experienced headaches. Use the normal distribution as an
approximation to the binomial distribution and assume a 0.05
significance level to complete parts (a) through (e) below.
A. Is the test
two-tailed, left-tailed, or...

A certain drug is used
to treat asthma. In a clinical trial of the drug, 25 of 289
treated subjects experienced headaches (based on data from the
manufacturer). The accompanying calculator display shows results
from a test of the claim that less than 18% of treated subjects
experienced headaches. Use the normal distribution as an
approximation to the binomial distribution and assume a 0.01
significance level to complete parts (a) through (e) below.
A. Is the test
two-tailed, left-tailed, or...

A certain drug is used
to treat asthma. In a clinical trial of the drug, 20 of 262
treated subjects experienced headaches (based on data from the
manufacturer). The accompanying calculator display shows results
from a test of the claim that less than 12% of treated subjects
experienced headaches. Use the normal distribution as an
approximation to the binomial distribution and assume a 0.05
significance level to complete parts (a) through (e) below.
A. Is the test
two-tailed, left-tailed, or...

In a clinical trial of Lipitor, a common drug used to lower
cholesterol, 863 patients were given a treatment of 10-mg
Atorvastatin tablets. Among them, 19 patients experienced flu
symptoms and 844 patients did not.
a) Estimate the probability that a patient taking the drug will
experience flu symptoms.
b) Is this unusual for a patient taking the drug to experience
flu symptoms? Explain.
c) If you know that the probability of flu symptoms for a person
not receiving any...

A clinical trial is conducted comparing two anticoagulant drugs.
240 patients meeting all inclusion criteria are randomly assigned
to receive drug 1 or drug 2. After one year, 40 of the patients
receiving drug 1 and 20 of the patients recieving drug 2 reported a
blood clot.
Number with blood clots after 1 year (successes)
Number without blood clots after 1 year
Sample Size
Drug 1
40
80
120
Drug 2
20
110
120
Which of the following would be...

1. For Drug X, Cmax occurs at 4 hours post-dose, but maximum
response does not occur until 8 hours post-dose. What would you
expect to see on a hysteresis plot of concentration-response for
this drug?
Group of answer choices
A. Counter-clockwise hysteresis
B. Uni-directional hysteresis
C. Clockwise Hysteresis
D. Bi-directional hysteresis
2.
A population
pharmacokinetic model was developed using sparse pharmacokinetic
data from two phase III studies. A method for evaluating this
model’s performance on estimating the PK parameters is:...

ADVERTISEMENT

Get Answers For Free

Most questions answered within 1 hours.

ADVERTISEMENT

asked 2 minutes ago

asked 14 minutes ago

asked 16 minutes ago

asked 20 minutes ago

asked 20 minutes ago

asked 36 minutes ago

asked 45 minutes ago

asked 59 minutes ago

asked 59 minutes ago

asked 1 hour ago

asked 1 hour ago

asked 1 hour ago