Letter to the Editor: Surgical Timing and Neurological Outcomes in Traumatic Central Cord Syndrome: A Single-Center Retrospective Cohort Study. [PDF]
Wang Z.
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Are clinician-administered ataxia scales truly culture-free? Rethinking contextual validity in diverse populations. [PDF]
Narzari H +4 more
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Evaluation of a Wearable Device for Cardiorespiratory Monitoring in Healthy Anaesthetised Cats. [PDF]
Melek Ş +3 more
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Efficacy and safety of TQC3403 in patients with chronic obstructive pulmonary disease (COPD): a multicenter, randomized, open-label, phase 3 equivalence trial. [PDF]
Chen D +11 more
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Short-Term HbA1c Non-Inferiority of Synthetic Semaglutide Should Not Be Conflated With Full Therapeutic Interchangeability. [PDF]
Singh AK, Singh A, Singh R.
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The therapeutic equivalence of complex drugs
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
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Related searches:
Understanding Therapeutic Equivalence in Epilepsy
CNS Spectrums, 2010ABSTRACTThe 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
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On the Definition of Therapeutic Equivalence
Drug Information Journal, 2000What 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
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Therapeutic equivalence: fallacies and falsification
Statistics in Medicine, 2003AbstractThe 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
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