Glossary of pharmaceutical and GMP terms with explanations

In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).

Therapeutic equivalence

Drugs may have different brands or manufacturers, but are recognized as equivalent if they are therapeutically equivalent and can therefore be used interchangeably.

Therapeutic equivalence (German translation: therapeutische Äquivalenz) is a concept used in medicine and pharmacy to compare two or more drugs to determine whether they can achieve the same therapeutic outcomes in patients under certain conditions. Drugs may have different brands or manufacturers, but are recognized as equivalent if they are therapeutically equivalent and can therefore be used interchangeably.

Two drugs are considered to have therapeutic equivalence if they achieve the same therapeutic effect when the same patient uses them in the same dose. The prerequisite is therefore that they contain the same active pharmaceutical ingredient in the same dosage and are available in the same or at least a comparable dosage form. Usually, bioequivalence of two drugs is also a prerequisite for therapeutic equivalence, although the terms are not entirely interchangeable. However, sometimes drugs with different bioequivalence (German translation: Bioäquivalenz) are still therapeutically equivalent due to a large therapeutic index, i.e. they have equivalent efficacy and safety.

Therapeutic equivalence is important for patients and healthcare professionals as it allows them to choose the most appropriate drug based on market availability and the patient’s individual needs. Not every drug is always available and, particularly in times of supply shortages (translation into German: Lieferenpässe), it may be necessary to substitute one therapeutically equivalent drug with another.

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