List the goals for each phase of the clinical trial: 1. Pre-clinical investigations 2. Phase I...

List the goals for each phase of the clinical trial:

1. Pre-clinical investigations

2. Phase I

3. Phase II

4. Phase III

5. Phase IV

Solutions

Expert Solution

1. Pre-clinical trials: Test the effect of drugs on animal and human cell morphology and physiology, followed by testing on animals with similar target organs as humans

2. Phase I: A very small number of candidates are chosen to test the safety of the drug in humans, and to determine the dosage

3. Phase II: Test efficacy of the drug in a large group, with blind and double blind procedures to maintain tamper free results

4. Phase III: Tests effectiveness, adverse effects, additional benefits of the drug in various patients who are chosen based on pre-existing conditions which are targeted by the drug

5. Phase IV: This consists of continued research after the drug is released, providing new information about drug-drug and drug-food interactions, compare quality of life and measure cost-effectiveness of the drug

gladiator answered 1 year ago

Next > < Previous

Related Solutions

Match the following definitions with the type of clinical trial:(a) preclinical, (b) phase I, (c)...

Match the following definitions with the type of clinical trial: (a) preclinical, (b) phase I, (c) phase II, (d) phase III, or (e) phase IV. ____ Studies involving animals or cell cultures. ____ Conducted to determine the safety of a treatment in humans. Patients go through intense monitoring. ____ Large studies (may or may not be a randomized trial) conducted after the therapy has been approved by the FDA to assess the rate of serious side effects and explore further...

1. Suppose a researcher is interested in carrying out a phase II clinical trial in order...

1. Suppose a researcher is interested in carrying out a phase II clinical trial in order to assess the effectiveness of four different doses of an investigational new drug. Assume the following table represents the summary statistics revolving around the number of adverse events in the four fasting glucoses among the groups. Fasting Glucose Treatment Group 124 1 124 1 125 2 134 2 138 2 137 2 136 2 119 1 124 3 120 1 116 3 124 3...

how do I perform a clinical trial for Xiliiarx in the treatment of Type 2 diabetes as a pharmacist assuming I want to do the same as the previous clinical trial?

how do I perform a clinical trial for Xiliiarx in the treatment of Type 2 diabetes as a pharmacist assuming I want to do the same as the previous clinical trial? What are the step by step specific activities I need to carry out for a successful clinical trial?

________________________Directions: Answer the questions and submit to Week #6 assignment 1.) Pre-Operative Phase – List 3...

________________________Directions: Answer the questions and submit to Week #6 assignment 1.) Pre-Operative Phase – List 3 criteria a pre-operative surgical RN would assess in a patient who is having upcoming surgery. Explain what the Pre-Anesthesia Care Unit (PACU) is .2.) Intra-Operative Phase – Discuss role of “Circulating RN” during a surgical procedure. Discuss role of Scrub Tech/Scrub RN during a surgical procedure. 3.) Post-Operative Phase – Explain what occurs during PACU Phase I and Recovery Phase II after a surgery...

1) List three clinical specimens from a patient should never be refrigerated. 2) List five clinical...

1) List three clinical specimens from a patient should never be refrigerated. 2) List five clinical specimens from a patient should always be refrigerated if delay in transportation is expected.

In a Phase II clinical trial with a binary endpoint, 8 out of 20 patients responded...

In a Phase II clinical trial with a binary endpoint, 8 out of 20 patients responded to a new drug. Let X be the total number of patients responding to the new drug among the 20 patients and pi be the population response rate. Please specify the distribution of X and obtain a 95% confidence interval for pi.

Q. 1. Explain the Occupational Low back pain with account of Contributor factors, Clinical assessment, Investigations,...

Q. 1. Explain the Occupational Low back pain with account of Contributor factors, Clinical assessment, Investigations, Clinical and Occupational Management and Prevention. Q. 2. Give an account on Repetitive Strain Injury (RSI) with full details of Synonyms, Clinical features, Relevant exposure, Other contributed factors, Extent of other problems, Treatment and Prevention. PLEASE answer all question WITHOUT copy past i need unique answer,,

list 5 policies for medicare and identify what goals each each adresss

List TWO CAUSES of EACH clinical condition. Explain why it causes this clinical condition.

List TWO CAUSES of EACH clinical condition. Explain why it causes this clinical condition.- HYPOTHYROIDISM1.2.- HYPERTHYROIDISM1.2.

1. List the mortgage approval process from pre-approval through to the deed to the property 2....

1. List the mortgage approval process from pre-approval through to the deed to the property 2. What is the Loan Processor role? Why is it significant to the Home Loan process? Who do they interact with and pass their findings to? 3. What is the Underwriter role? Why is it significant to the Home Loan process? Who do they interact with and pass their findings to? Why are they important to the loan process? 4. Discuss the important pieces of...

Subjects