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What phase of clinical testing is required by the FDA before drug approval and uses the greatest number of subjects.?
C. phase 3 your welcome :)
What phase of clinical testing is required by FDA before drug approval and uses the greatest number of subjects?
C. phase 3 your welcome :)
What phase of clinical testing is required by the FDA before drug approval and uses the greatest number of subjects?
C. phase 3 your welcome :)
Would you define clinical trial phases?
Phase I Trials: Primarily concerned with the drug's safety. Done on Healthy subjects and its the first time studied in humans. Amount of subjects to be used is approximately 20-100. Done in a hospital setting so side effects can be monitored more closely. Phase II Trials: Once tested in healthy subjects, its time to be done on the diseased subjects in which the drug is intended to cure or help. They are randomised studies as well in which case its usually blinded to all involved in the study and a Placebo is used. Several hundred subjects are tested and the company is concerned here with safety and efficacy of the drug. Lasts for about several months to a few years. Phase III Trials: Several hundred to several thousand subjects are needed for ph. 3 trials. Usually safety and efficacy again are involved to check more closely though, on severity of the adverse events. These studies can last years. Looks at study benefits, risks, etc. Phase IV Trials: Phase IV involves marketing the drug. Once the study is ended in Phase III, the study needs to be marketed. The FDA is notified of the end and results and the company applies then for the NDA (new drug application). The marketing is done for the public and looks at long term safety.
What are phase 2 a clinical trials?
Phase II clinical trial determines the effectiveness and safety of the candidate drug in patients suffering from the condition the new drug is designed to treat. The main question that is answered in phase II studies is: "What is the most effective dosage range and the drug safety within that range?" Phase II studies enroll 100 to 300 subjects, and depending upon the type of investigational drug and the condition it treats, the trial lasts anywhere from six months to two years. Phase 2 is sometimes further classified into 2a and 2b phases based on the type of trials: Phase 2a assesses the amount of drug to be given to the subject for optimal results. Phase 2b assesses the how well the drug works at the prescribed dosage levels. Know more about the phases involved in clinical trials: http://www.crocareers.in
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 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.
What are the 3 phaes for Mesothelioma Clinical Trials?
In phase one the dosage and safety of a drug is determined. In phase two they determine how effective the drug is on the targeted illness. In phase three they determine how effective the drug is compared to other drugs.
What are the phases of drug metabolism?
There are two phases of drug metabolism: Phase I - Functionalizes the drug molecule. In this phase, there are addition or modification of functional groups in order to make them more susceptible to phase II of metabolism. Phase II - Conjugates the molecule. In this phase, the functional handles of the molecule can be conjugated to highly hydrophilic molecules in order to facilitate the excretion.
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 is the Mechanism of drug action?
Pharmaceutical phase, Pharmacokinetic phase and Pharmacodynamic phase
