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The therapeutic equivalence of complex drugs

open access: yesRegulatory Toxicology and Pharmacology, 2011
When the patent of a small molecule drug expires generics may be introduced. They are considered therapeutically equivalent once pharmaceutical equivalence (i.e. identical active substances) and bioequivalence (i.e. comparable pharmacokinetics) have been established in a cross-over volunteer study.
Schellekens, Huub   +5 more
openaire   +6 more sources

Understanding Therapeutic Equivalence in Epilepsy

CNS Spectrums, 2010
ABSTRACTThe issues surrounding generic drug substitution in patients with epilepsy are complex.The substitution of one formulation of an antiepileptic drug (AED) for another is controversial. Well-reasoned and defensible cases can be made both for and against such substitution.
Raman, Sankar, Tracy A, Glauser
openaire   +2 more sources

On the Definition of Therapeutic Equivalence

Drug Information Journal, 2000
What do we mean by therapeutic equivalence and how do we prove that two drugs are therapeutically equivalent? We suggest that therapeutic equivalence should be defined and demonstrated using predefined limits on the dose scale rather than on the effect scale.
Anders Källén, Per Larsson
openaire   +1 more source

Therapeutic equivalence: fallacies and falsification

Statistics in Medicine, 2003
AbstractThe number of studies designed specifically to demonstrate therapeutic equivalence or alternatively non‐inferiority of pharmaceutical treatments has increased dramatically in recent years, during which time awareness of the methodological issues has increased. Regulatory authorities have been quick to recognize the need for specific support and
openaire   +2 more sources

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