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
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.
You might also like to view...
Which patients would be candidates for genetic testing for long QT syndrome (LQTS). (Select all that apply.)
a. Patients with prolonged QT interval during a cardiac and genetic work-up b. Family history of positive genotype and negative phenotype. c. Patients diagnosed with torsades de pointes d. Family history of sudden cardiac death e. Family history of bleeding disorders f. Family history of obesity
When planning care for a patient with melena, the nurse expects which appearance of the stool?
A) Coffee ground appearance of the stool B) Black and tarry stools C) Bright red blood in the stool D) Visually undetectable blood
Medication measured in a medicine cup should be measured at eye level to ensure accuracy
Indicate whether the statement is true or false
A patient is experiencing a panic attack. What did the nurse assess to make this clinical determination? (Select all that apply.)
1. Sweating 2. Trembling 3. Nausea 4. Checking 5. Breathing difficulty