Which phase of clinical research involves basic science research?
1. Submission of NDA
2. Clinical phase trials
3. Postmarketing study
4. Preclinical investigation
4
Rationale 1: A review of the NDA is the third stage of drug approval. During this stage, clinical phase III trials and animal testing may continue, depending on the results obtained from preclinical testing. If the NDA is approved, the process continues to the final stage. If the NDA is rejected, the process stops until concerns are addressed.
Rationale 2: During these phases, clinical pharmacologists, researchers, and healthcare providers examine data from volunteers and large groups of selected patients with certain diseases.
Rationale 3:Postmarketing surveillance is the fourth stage of the drug approval process. It takes place after clinical trials and the NDA review process have been completed. Testing in humans is continued to check for any new harmful effects in larger and more diverse populations.
Rationale 4: Preclinical investigation involves basic science research.
Global Rationale: Preclinical investigation involves basic science research. A review of the NDA is the third stage of drug approval. During this stage, clinical phase III trials and animal testing may continue, depending on the results obtained from preclinical testing. If the NDA is approved, the process continues to the final stage. If the NDA is rejected, the process stops until concerns are addressed. During these phases, clinical pharmacologists, researchers, and healthcare providers examine data from volunteers and large groups of selected patients with certain diseases.
You might also like to view...
The nurse caring for a 91-year-old patient with osteoarthritis is reviewing the patient's chart. This patient is on a variety of medications prescribed by different care providers in the community
In light of the QSEN competency of safety, what is the nurse most concerned about with this patient? A) Depression B) Chronic illness C) Inadequate pain control D) Drug interactions
The nurse is teaching a group of menopausal women about the signs and symptoms of menopause and how they can get relief. One of the main concerns of the group is vaginal dryness and difficult intercourse
What is the reason the nurse will give for this? 1. The loss of cervical gland function leads to dryness of the mucous membranes of the vagina. 2. The vaginal pH increases, and the number of Doderlein's bacilli decreases. 3. The uterine lining thins and the muscle layer atrophies. 4. The labia shrink and lose their pigmentation.
The nurse is participating in a clinical study of the effects of teaching on drug compliance. The subjects are randomly assigned to either an experimental group or a control group
Health professionals deliver one of two teaching modules to each patient. This is an example of which kind of study? a. Double-blind b. Open-label c. Single-blind d. Triple-blind
A patient with a somatic symptom disorder has the nursing diagnosis: Interrupted family processes, related to patient's disabling symptoms as evidenced by spouse and children assuming roles and tasks that previously belonged to patient
An appropriate outcome is that the patient will: a. Assume roles and functions of the other family members. b. Demonstrate a resumption of former roles and tasks. c. Focus energy on problems occurring in the family. d. Rely on family members to meet his or her personal needs.