Myofibre Density Reveals a Critical Threshold Around Age 6 in Steroid-Naïve Duchenne Muscular Dystrophy: A Retrospective Observational Study. [PDF]
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TRANSLATION, CULTURAL ADAPTATION, AND SEMANTIC VALIDATION OF THE PEDIATRIC NEUROGENIC BOWEL DYSFUNCTION SCORE (NDBS) INTO BRAZILIAN PORTUGUESE AND A PILOT STUDY. [PDF]
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Functional Outcomes of Miniplate/Screw Versus Suzuki Frame Fixation in Eaton Type III Middle Phalanx Base Fractures: A Case Series. [PDF]
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Rethinking the role of the pretend play mode in mentalisation-focused psychoanalytic child therapy for adopted and foster children with attachment trauma: from a pre-mentalising mode to a developmental achievement and a milestone on the trajectory towards mentalisation. [PDF]
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The therapeutic equivalence of complex drugs
Regulatory Toxicology and Pharmacology, 2011When 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.
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BACKGROUND AND AIMS Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor to treat type 2 diabetes mellitus, is available as immediate release (IR) tablets administered at 50 mg twice daily (BID).
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Community pharmacists' understanding and perceptions of FDA therapeutic equivalence standards
Research in Social and Administrative Pharmacy, 2019Background: Pharmacists need to demonstrate knowledge of and have confidence in Food and Drug Administration (FDA) therapeutic equivalence (TE) standards to improve acceptance of generic medicines amongst patients and other healthcare professionals ...
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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.
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