An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint. Unfortunately, participants are not happy about visiting the clinic weekly, and they are considering dropping out. Therefore, a protocol amendment is being prepared to remove the weekly blood draw. This change can be implemented once the protocol is finalised and submitted to the FDA.
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What is the FDA?</h3>
The Federal Food and Drugs Act, which was passed in 1906, led to the creation of the Food and Drug Administration (FDA). The organisation is divided into divisions, each of which is in charge of the majority of the organisation's responsibilities relating to food, medicines, cosmetics, animal food, nutritional supplements, medical devices, biological products, and blood products.
The FDA is renowned for its efforts to control the creation of new medications. All new pharmaceuticals must undergo clinical trials, according to regulations set down by the FDA. Before medicines may be offered to humans, pharmaceutical companies must put them through four stages of clinical testing.
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Answer:
well
Explanation:
what's this I don't understand
Micheal might be suffering from diabetes insipidus.
Diabetes insipidus
Diabetes insipidus is a condition in which the affected person has the urge to pee a lot and feels thirsty all the time. Even though it is not directly related to diabetes, it is named as such because the affected person has symptoms similar to diabetes. The two main symptoms are polydipsia and polyuria.
Cause of Diabetes insipidus
Diabetes insipidus is caused by the lack of production of antidiuretic hormone (ADH). ADH is produced by the hypothalamus which then gets stored in the pituitary gland. When the person was subjected to surgery to remove the entire mass of cancer cells in the pituitary gland, the ability of the gland to store ADH could have been lost.
The ADH allows the retention of water by concentrating the urine. In a person with diabetes insipidus, the production of AHD is affected, and in very rare cases the response by the kidneys to ADH is reduced which also reduces the water reabsorption and increases urine volume.
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Answer:
an inherent component
Explanation:
ability to speak fluently and eloquently in public.
Answer:
Electronic health records are a major source of phenotypical data. : True-a.