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Drug trials help evaluate the safety of a drug compound in human population and its pharmacological efficacy. Drug trials also help companies identify how well the drug works for a given disease and what side effects to expect. The data extrapolated from the study is used to get FDA approval to market the drug and is used by doctors and pharmacists for medical treatments.
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Stakeholders in clinical trials?
Clinical trials are experiments to find out how effective a drug is, and if there are any side effects. The stakeholders in clinical trials are the patients, doctors, drug companies, drug manufacturers, and pharmacists.
What agency conducts trials and approves new drugs?
U.S. Food and Drug Administration requires drug trials and approve or disapprove new drugs based on these trials, but they do not conduct the trials. The trials are conducted by the organization who sponsors the drug (wants it approved). This can be a pharmaceutical company or a government agency.
What has the author Tom Brody written?
Tom Brody has written: 'Clinical trials' -- subject(s): Research Design, Clinical Trials Data Monitoring Committees, Drug Approval, Clinical Trials as Topic, Clinical trials, Drug approval
What are the ethics of clinical drug trials?
yes
Give two reasons why clinical trials have to be done before drugs are made freely available?
There are many reasons why clinical trials need to be conducted before making new drugs commercially available. First of all, drug makers need to be sure that a drug is safe, this is tested by giving the drug to a group of volunteers in a controlled environment (staying at a clinic for several days) and monitoring their vital signs, their blood chemistry, and checking for any side effects. Secondly, clinical trials are needed to determine whether a drug is effective at treating a certain condition. Drugs in clinical trials are given blind, meaning that the doctor nor the patient knows whether someone is taking the drug being studied or a placebo (sugar pill). Studying the effects of the drug in this scenario can prove whether the drug is effective. Finally, clinical trials are also used to determine the proper dose of a drug by giving escalating doses to volunteers and monitoring the blood levels of the drug and watching for any side effects.
Where do clinical trials for a new drug take place?
what protein is a new drug most likely to be
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.
How does a pharmaceutical company invest in research and experimental studies?
These organizations are completely involved in drug manufacturing processes along with the drug’s clinical trials and phases, drug launch in the market, and its commercialization. Pharmaceutical invests in the research and experimental studies for the drug innovation and once the designing of the drug is finalized, they are often outsourced to the contract manufacturing organizations to manufacture the drug and undergo clinical trials and finally commercialize the drug.
Why are animals used in drug trials?
Primarily due to the fact that test animals allow for drug trials without endangering the lives of human beings. The practice, while highly debatable in ethics, gives the manufacture an idea of what positive and negative effects may occur if human trials were done.
What is scientific evidence?
Well that is a vague question, but in medicine there needs to have been clinical trials that prove that a particular drug works. Studies need to be done comparing the drug in question against a placebo. One group will receive the drug and another will receive the placebo. If the drug works, there should be significant number of patients who obtain the desired results.
What ethical issues might arise when a drug company funds trials of a new drug it has developed to treat a genetic disorder?
you are in my science class.
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
