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:
1. beats slower than 60 beats per minute
2. chronic autoimmune disease
3. a branch in the medical field
4. Having the effect of relieving pain and inducing drowsiness, stupor, or
insensibility.
5. obstruction of an artery, typically by a clot of blood or an air bubble.
Explanation:
They are able to use imperatives and interrogatives.
They frequently use the auxiliary verb "have" in statements.
Answer:
The white blood cells i.e. granulocytes and macrophages are specifically stimulated by GM-CSF in response to chemotherapy in cancer patients.
Explanation:
The colony stimulating factors (CSFs) are the regulators of granulocytes and macrophages in blood. The CSFs has the potential to regenerate the white blood cells damaged during chemotherapy. Thus, CSFs mobilize the stem cells to enhance the immune process and produce hematopoietic cells such as granulocytes, macrophages in cancer patients. The CSFs resemble hormones that are specifically targeted to produce blood cells in specified regions where the quantity of those cells is low. The CSFs belong to a group of regulatory factors also known as cytokines and does not produce only a single cell type but stimulates colonies of different blood cell types for any specific organ. Hematopoietic cells produced by CSF are step-wise and formation of blast colonies take place initially. Afterwards, the blast cells regenerate and differentiated into multiple progenitor cells consisting of granulocytes, monocytes, macrophages, eosinophills, erythroids, and lymphocytes. The progenitor cells in the granulocyte-macrophage lineage matures into neutrophilic granulocytes and macrophages.
Out of all types of CSF colonies, the Granulocyte-Macrophage (GM-CSF) colony is specially involved in regenerating immune responses in cancer patients. These cytokines stimulates the dendritic cell formation and produces dendritic activity against the cancerous cells. These GM-CSF colonies enhance the immune response of host against melanomas, tumors by reducing their growth and inducing remission. Hence, it can be said that granulocytes and macrophages are infection protective cells and elevates dangerously low levels of white blood cells in cancer patients following chemotherapy. The GM-CSF induction regenerates the bone marrow which is damaged and improves stem cells production.
precision and accuracy of patient sample results important to both management of overall quality
