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forsale [732]
3 years ago
9

Which clinical step is omitted for biosimilar agents?

Biology
1 answer:
Marysya12 [62]3 years ago
4 0
There are normally four steps to approve (or not ) a medicine:
step 1: it must be proven that this drug is not toxic
step 2: it must be proven that this drug is active on sick people
step 3: it is compared to other drugs which have the same indication
step 4: is the pharmacovigilance. The drug is monitored during all its commercialization.

During the approval of biosimilar agents, step 2 is omitted because we need to establish that there are “no clinically meaningful differences” in the efficacy and safety<span> of the biosimilar when compared to the original, which can be done in step 3.</span>
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Explanation:

Temperature and the changes in it are part of quantitative observations because these can only be measured and understood through numbers. Indeed, the temperature is globally measured through different numerical scales such as the Celsius or the Kelvin scale. This does not occur in other qualities such as color because this is considered and analyzing using qualities or traits rather than values. According to this, the correct answer is "The temperature of the water decreased by 5°C."

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Infectious are more easily spread nowadays becuse of an increased population. The more the population increases, the bigger the advantage an infectious disease has. As of right now, because everyone is wearing masks, their immune systems are being weakened. Another reason for this is because of the increase in chemicals in our foods, which are now being transferred to our bodies. All of the medications people are taking also have an affect on the spread of disease; it gives diseases a chance to mutate.

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