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Phase 2a Clinical Trials are pilot studies done on a relatively smaller number of patients(100-300) in order to judge the efficacy and safety of the investigational drug.
Whereas Phase 2b Clinical trials are Pivotal studies, a well established controlled trails done on a larger number of patients in order to judge the efficacy and safety of the investigational drug.
What else can I help you with?
Which type of clinical trials is used the least?
Phase IV trial
What is the difference between phase 3 and pivotal phase 3 clinical trials?
Trial from which data will be used to make significant claims These are the well designed Phase III trials whose data is generally used to get marketing approvals and information provided in the Package Insert or Product Information Leaflet. These are not to be confused with pilot studies or trials that ar done to only access the logistic check by enrolling few patients.
What are phase 2 b clinical trials?
Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)). Drug efficacy was usually studied in Phase III trials but the pressure to cut costs during the clinical trials process has increased the use of Phase IIB trials that can already give clues as to how effective the drug will be at treating a certain condition.
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
When are drugs tested on humans?
After clinical animal trials at: Phase 1 - small group of healthy volunteers are tested
What is Clinical Trails?
Clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related involvement to evaluate the effects on health outcomes. Clinical research trials may be conducted by government health agencies such as NIH (National Institute of Health), researchers affiliated with a hospital or university medical program, independent researchers, or private industry. Clinical trial interventions include but are not restricted to: Experimental Drugs Cells and Other Biological Products Vaccines Medical Devices Surgical and Other Medical Treatments and Procedures Psychotherapeutic and Behavioural Therapies Health Service Changes Preventive Care Strategies and Educational Interventions. Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease. Types of Clinical TrialsThere are two main types of clinical trials: Observational clinical trials do not test drugs or treatments. Researchers observe participants by monitoring their health over a period of time. These studies provide researchers with data that advances our understanding of Parkinson’s and how to treat the disease. Interventional clinical trials test the safety and effectiveness of a candidate drug, therapy or experimental treatment. Clinical trials also can be classified as follows: Treatment trials Prevention trials Screening trials Quality of Life trials Genetics trials Phases in Clinical Trials: Phase 0: Number of Subjects (10-15) Phase I: Screening for safety: Number of Subjects (20-80) Phase II: preliminary efficacy of the drug: Number of Subjects (100-300) Phase III: Final confirmation of safety and efficacy: Number of Subjects (1000-3000) Phase IV: Post marketing studies.
What is the equation for calculating the phase difference between two waves?
The equation for calculating the phase difference between two waves is: Phase Difference (2 / ) (x) Where: Phase Difference is the difference in phase between the two waves is the wavelength of the waves x is the difference in position between corresponding points on the waves
What is the formula for calculating the phase difference between two waves?
The formula for calculating the phase difference between two waves is: Phase Difference (2 / ) (x) Where: Phase Difference is the difference in phase between the two waves is the wavelength of the waves x is the difference in position between corresponding points on the waves
Difference between ClinTrial and oracle clinical?
Both are Clinical Data Management Systems (CDMS), developed by different companies. ClinTrial is a product by Phase Forward and Oracle Clinical (OC) is a product by Oracle. Though they have different features, basic functionality is the same Check http://en.wikipedia.org/wiki/Clinical_data_management_system for more details about CDMS Basically CDMS systems are used in case of paper & hybrid (paper and EDC) trials.
What is the relation between the path difference and phase difference?
The phase difference between two waves is directly proportional to the path difference between them. The phase difference is a measure of how much the wave has shifted along its oscillation cycle, while the path difference is a measure of the spatial separation between two points where the waves are evaluated.
Phase 4 of Clinical Trials and the New Drug Application may take years to monitor durability of response?
5 to 10 years
Clinical trials have how many phases?
Clinical trials typically have four phases: Phase 1 involves small groups of healthy volunteers to assess safety and side effects; Phase 2 involves a larger group to see if the treatment works; Phase 3 involves an even larger group to further evaluate efficacy and monitor side effects; and Phase 4 occurs after the drug has been approved and involves long-term monitoring.
