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.
<h3>
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.
To know more about FDA, visit:
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Answer:
Given
Per Kg of body mass, there is 3 gram of potassium
And abundance of three isotopes are as follows
Potassium-39, Potassium-40, and Potassium-41. Have abundances respectively as 93.26%, 0.012% and 6.728%.
1) A body weighing 80 Kg will have 240 grams of potassium. And the amount of Potassium-40 will be 0.012% of 240 gram
= 240*0.012/100 = 0.0288 gram.
2) Dose in (Gy) = (energy absorbed)/(mass of the body) = ( 1.1*106*1.6*10-19)/(80) = 22*10-10 J/kg
Dose (in siverts) = RBE*Dose(in Gy) = 1.2*22*10-10 = 26.4*10-10
Answer:
the correct answer is option a, b, d, and f.
Explanation:
When the body is not able to make enough healthy RBCs due to B-12 deficiency this condition called pernicious anemia. It is a treatable condition with the help of the B-12 shots or pills. The major reason is the lack of a stomach protein known as Intrinsic factor which is essential for the absorption of the B-12.
Symptoms associated with this condition are -
Fatigue, shortness of breath, cold hands and feet, Paresthesias, feeling dizzy, chest pain, pale or yellow skin, depression, and trouble focusing and others.
Thus, the correct answer is option a, b, d, and f.