Abstract

Summary Drugs that do not have a critical dosage and are commonly used together, can justifiably be combined in a single product. Such combinations are more convenient to doctor and patient and have reduced risk of treatment error and drug interaction. Combination products include more than one active drug, each of which has its own chemical and physical properties, so that they are complex formulations. Copies of combination products are, therefore, even less likely to have comparable performance than copies of single drugs. Generic copies are encouraged by pharmacopoeial monographs and the current inclusion of complex formulations and combinations in the BP may allow a new era of clinical non-equivalence from products considered to be generically equivalent.

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