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Author Question: A nurse is assisting in drug trials that have reached the stage in which potential new indications ... (Read 158 times)

awywial

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on: Jul 23, 2018
A nurse is assisting in drug trials that have reached the stage in which potential new indications for approved drugs are investigated. The nurse is aware that this phase is known as phase:
 
  a. I.
  b. II.
  c. III.
  d. IV.

Question 2

Clinical experimentation occurs in four stages. The determination of the human dosage range based on responses in healthy subjects is a goal of phase _____ of human clinical experimentation.
 
  a. I
  b. II
  c. III
  d. IV


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Ashley I

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Reply #1 on: Jul 23, 2018
Answer to Question 1

ANS: D
Phase IV studies may examine potential new indications for approved drugs.

Answer to Question 2

ANS: A
Phase I trials are primarily designed to assess safety. The objectives of phase I are to determine the human dosage range based on response in healthy human subjects and to identify the pharmacokinetics (i.e., absorption, distribution, metabolism/biotransformation, excretion/elimination) of the drug. Progression to the next phase occurs if no serious adverse effects are demonstrated, the drug is eliminated in a reasonable amount of time, and the dose range is below that known to induce pathology in animals.


awywial

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Reply #2 on: Jul 23, 2018
Thanks


Ashley I

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Reply #3 on: Jul 23, 2018
Welcome :)


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