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Does therapeutic equivalent code meet bioequivalence?
1) Yes
2) No

1 Answer

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Final answer:

A therapeutic equivalent code does meet bioequivalence according to the FDA, which requires that therapeutic equivalents be bioequivalent to the branded drug they replicate.

Step-by-step explanation:

The question whether a therapeutic equivalent code meets bioequivalence can be addressed with a confident 'Yes'. According to the FDA guidelines, for a drug to be deemed a therapeutic equivalent, it must be pharmaceutically equivalent and bioequivalent. This means that therapeutic equivalents must deliver the same amount of active ingredient into a patient's bloodstream in the same amount of time as the original product. The FDA has detailed guidelines and criteria for determining bioequivalence, including in vivo and in vitro studies that assess the drug's release into the bloodstream.

This ensures that the generic version of a drug will have the same therapeutic effect and safety profile as the brand-name version, provided it is administered in the same manner. Therefore, therapeutic equivalents are considered bioequivalent and can be used interchangeably with the brand-name drug they replicate.

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