Which of the following is essential for drug products to be considered bioequivalent and not just chemically equivalent by the FDA?
They must have similar brand names. |
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They must have the same active ingredient or ingredients. |
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They must have similar dosages. |
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They must have the same route of administration. |
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They must have similar rates of release into the body. |
ANSWER:-
OPTION:-E
They must have similar rates of release into the body...
If their rates and extent of absorptiont do not show a significant difference from the rate and extent obsorption of the reference drug when administered at same molar dose of therapeutic ingradient under similar experimental conditions either in singlesor multiple doses are said to be bioequivalent and not just chemically equivalent by FDA
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