Question 6 What regulations must dietary supplements be subjected to? . They mus
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Question 6 What regulations must dietary supplements be subjected to? . They must pass the first three phases of clinical trials, but do not need to pass the fourth. o They do not need to pass clinical trials . They must pass clinical trials just like any other drug. o They must pass the first two phases of clinical trials, but not the last two. They must pass the first phase of a clinical trials, but do not need to pass the last three. Question 7 Which of the following is true of observational studies? They are the best way to form causal connections, as they demonstrate relationships between variables in their natural environments e They are great for generating hypotheses. e They provide broad, generalizable results. . They are the most often usej form of clinical trial.Explanation / Answer
6. Dietary supplements as a category of food are classified by the Dietary Supplement Health and Education Act (DSHEA). Hence, they are safe until proven otherwise. FDA regulations only requires clinical trials for drug. Dietary supplement do not require FDA approval. The DSHEA only allows FDA to stop a company from synthesizing a dietary supplement if there are reports of significant harm to Americans. Only if a new ingredient is present in the supplement, then the manufacturer should prove to FDA that this ingredient is a safe for consumption.
Right choice: They do not need to pass clinical trials.
7. An observational study studies individuals in a sample. However, it does manipulate or influence the variables of interest. They can be cross-sectional, cohort, or case controlled studies. A designed experiment, conversely, applies to treatments of individuals. It isolates the effects of a treatment as a response variable. Observation studies are prone to bias, although they provide data from large number of individuals with a low cost. They also allow longer follow-ups. Clinical data requires experimental step-up. Experimental study establishes causal connections while observational studies only establish associations between explanatory and response variable as they merely observe. The case controlled observational studies are used to generate hypotheses. These hypotheses are then studies by prospective cohort or other studies. Observational studies develop new hypotheses. Randomized controlled trials employ broad criteria. Hence, results can be generalized to larger populations.
Right answer: they are great for generating hypothesis.
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