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∙ 13y ago
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Define Post marketing surveillance in clinical trial?
PMS is defined as a new drug development i.e, pharmacovigillence
What is mean by post marketing surveillance?
Post-marketing surveillance refers to the ongoing monitoring of a drug or medical device after it has been approved and marketed. This process helps to identify, track, and evaluate any potential side effects, adverse reactions, or quality issues that may arise once the product is in broader use among patients. Post-marketing surveillance is crucial for ensuring the continued safety and effectiveness of healthcare products.
What phase in the development of pharmaceutical drugs is the drug tested on healthy human volunteers to test for toxicity and the body's handling of the drug?
phase I clinical trials
What are the three phases of drug effects?
There are three phases of drug effects. These three phases are the administration phase, active phase, and the metabolism phase.
What drug phase enrolls 1200 subjects?
phase 1
What is Pharmaceutical phase of drug action?
Pharmaceutical phase of drug action is the first of the three phases to drug action. It includes the disintegration of the dosage form as well as the dissolution of the drug
What is a phase IIa clinical trial?
A phase II clinical trial is the phase of testing to see whether or not a drug has any biological effect. The phase IIa trial is the phase in which it is determined what dosage of a drug should be given.
Does vector marketing drug test?
no
Which phase is directly affected when a cancer drug interferes with the development of mitotic spindle fibers during cell division?
Late prophase, metaphase, and anaphase would be negatively affected by a cancer drug that interferes with the development of mitotic fibers in cell division.
When was TGen Drug Development created?
TGen Drug Development was created in 2003.
What is TGen Drug Development's population?
The population of TGen Drug Development is 24.
What are phase 3 clinical trials?
Clinical trials are the process of evaluation of new drugs, devices, biological for their safety and effectiveness employing human being. These are carried out in Four different phases. Phase-1 This is carried out in healthy volunteer for determining the Pharmacokinetics and pharmacodynamics of the drug Phase-2 This is carried out in Patients (50-100) to evaluate the safety and efficacy of the drug Phase-3 Carried out on large number of patients to confirm the safety and efficacy of the dug. This is the phase on the basis of which companies get approval for marketing process of their drug. For this they have to submit all phase 3 data to the regulatory authorities in addition to other phases data and preclinical studies data. Phase-4 Involve v large population after the drug get market approval Ms Abhinandan Sandhu Faculty (Clinical Research)
