A client who is terminally ill reports hearing about a drug that is in preclinical investigation. The client asks the nurse if the drug will be available to the public soon. What should the nurse consider when formulating an answer to this question?

1. After preclinical investigation the drug has one more step before being released for public use.
2. The average length of preclinical investigation is 18 months.
3. When the drug reaches the clinical investigation stage it is usually released within 2 years.
4. The drug will not be available until after the post-marketing studies are done.


2
Rationale 1: Preclinical investigation is the first of three stages the drug must go through before being released for use.
Rationale 2: Preclinical investigation may last 1 to 3 years with 18 months being the average.
Rationale 3: Clinical investigation may last 2 to 10 years with 5 years being the average.
Rationale 4: Post-marketing studies are started as soon as the NDA review is completed and may continue for years after drug release.
Global Rationale: Preclinical investigation is the first of three stages the drug must go through before being released for use. Preclinical investigation may last 1 to 3 years with 18 months being the average. Clinical investigation may last 2 to 10 years with 5 years being the average. Post-marketing studies are started as soon as the NDA review is completed and may continue for years after drug release.

Nursing

You might also like to view...

A 56-year-old woman will soon begin treatment of her overactive bladder with tolterodine (Detrol). What patient teaching should the nurse provide to this woman?

A) "It's good to measure your heart rate before you take your Detrol each day, and withhold it if your heart rate is below 60 beats/minute." B) "You'll probably need to stop taking your hormone replacement therapy when you're taking Detrol." C) "You'll likely find that you have scant amounts of blood in your urine for the first few days, but this is not unusual or problematic." D) "You might find that you get a dry mouth or a headache from this drug, but this does not mean it has to be discontinued."

Nursing

Which principle takes priority when addressing a behavioral crisis in an inpatient setting?

a. Resolve the crisis with the least restrictive intervention possible. b. Rights of an individual patient are superseded by the rights of the majority of patients. c. Swift intervention is justified to maintain the integrity of a therapeutic milieu. d. Allow patients opportunities to regain control without intervention if the safety of other patients is not compromised.

Nursing

Conflict can be positive because __________

a. it can engage people in aggressive discussion b. it can lead to innovation and creative decisions c. it identifies the stronger members of the team d. it fosters competition

Nursing

Which of the following terms is used to refer to a thick crust or scab that develops after skin has a traumatic wound or burn?

A. Argyria B. Eschar C. Lyse D. None of these

Nursing