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What other benefits do I get from taking part in a BE study?
You will be compensated for your time and inconvenience, and reimbursed for expenses incurred. Also, a medical report will be given to you free of charge upon completion of a BE study....
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Can I leave a study after it has begun?
Yes. Your participation in a study is voluntary. You can choose to leave the study at any time, for any reason without penalty or denial of benefits....
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What is informed consent?
Informed consent is your agreement to participate in a study after learning the important facts about the study. These facts include: Why the research is being done What the researchers want to accomplish what will be done during the trial and for how long What risks are involved in the trial What benefits can be expected from the trial What other treatments are available...
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Are there any risks?
The side effects are no more than taking a dose of medication. Possible side effects include headache, stomach upset and allergy. You will be given the details of the medication in the subject information sheet before you sign the informed consent. You may experience some discomfort from the blood collecting procedures. You will be covered with insurance for any adverse events you may encounter....
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Are BE studies safe? I don’t want to be a guinea pig!
The Malaysian government has strict guidelines and safeguards (Malaysian Guidelines for Good Clinical Practice [GCP]) to protect people who choose to take part in clinical studies. Every clinical study in Malaysia must also be approved, monitored and reviewed by the Independent Ethics Committee (IEC). The IEC consists of people from the medical field as well as lay people to make sure that a clinical...
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Should I take part in a BE study?
Choosing to participate in a BE study is a personal decision. Listed below are factors you may want to consider before volunteering: To learn more about health topics To monitor your health through free thorough physical and medical examinations, laboratory tests and E.C.G. To know that you are helping the advance of medical science and improvement of future healthcare To obtain satisfaction from helping...
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What happens in a BE study?
Volunteers will undergo a medical check-up before the study. For the study proper, they stay for one or more days in study wards reserved for clinical studies. They take one dose of a medical product (Either Brand A or Brand B) and allow the BE study team to collect their blood samples (about a teaspoonful each time) at fixed interval times for one or...
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Who takes part in a BE study?
Every year, several million subjects in the world participate in BE and clinical studies. A BE study requires volunteers who are healthy and pass certain inclusion and exclusion criteria, i.e. factors that allow you to and disallow you from taking part in the BE study....
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What is a bioequivalence (BE) study?
A BE study is a type of clinical study conducted to compare two products containing the same medicine but produced by different companies. This study checks if the two products produce similar concentrations in the human body at specific intervals after taking the products....
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Why do we need clinical studies?
These studies are done to see if the new drugs or treatments are safe and effective for people to use....
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