If two formulations are pharmaceutical equivalents, what must they contain?

When two formulations are described as pharmaceutical equivalents, they must contain the same drug substance, in the same salt form, and be of the same dosage form. This means that not only do they have to include the same active ingredient, but they also need to be in the same form of the drug, such as both being tablets or both being capsules.

This definition is crucial in ensuring that two different products can be expected to have the same therapeutic effect when used under the same conditions. While factors such as dosage strength might also be essential, the core requirement for equivalency specifically highlights the need for the same drug, salt form, and dosage form, making option B the most accurate representation of what defines pharmaceutical equivalents.

The other options do not satisfy the criteria laid out for pharmaceutical equivalence. Different dosage forms would refer to different formulations altogether, thereby excluding them from being equivalent. Identical brand packaging is not necessary for equivalency, as generic versions can have different packaging while remaining equivalent in active ingredients and dosage forms. Lastly, similar bioavailability rates relate more to bioequivalence, which is significant for assessing therapeutic substitution but does not align with what is strictly required for pharmaceutical equivalency.