Question

What is the goal of a phase II clinical trial? A. Demonstrate activity of the intervention....

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.

Homework Answers

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 .

Know the answer?
Your Answer:

Post as a guest

Your Name:

What's your source?

Earn Coins

Coins can be redeemed for fabulous gifts.

Not the answer you're looking for?
Ask your own homework help question
Similar Questions
Please prepare a brief description of the reasoning for your choice of answer. 1)What is not...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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
Need Online Homework Help?

Get Answers For Free
Most questions answered within 1 hours.

Ask a Question
ADVERTISEMENT