Results 251 to 260 of about 3,107,552 (340)

Myofibre Density Reveals a Critical Threshold Around Age 6 in Steroid-Naïve Duchenne Muscular Dystrophy: A Retrospective Observational Study. [PDF]

open access: yesNeuropathol Appl Neurobiol
Yamakado T   +10 more
europepmc   +1 more source

The therapeutic equivalence of complex drugs

Regulatory 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

Therapeutic equivalence of vildagliptin 100 mg once daily modified release to 50 mg twice daily immediate release formulation: An open-label, randomized, two-period, single- and multiple-dose, 6-day crossover study.

Diabetes & metabolic syndrome, 2022
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).
Ramachandra Sangana   +9 more
semanticscholar   +1 more source

Community pharmacists' understanding and perceptions of FDA therapeutic equivalence standards

Research in Social and Administrative Pharmacy, 2019
Background: 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 ...
Brandon J Euen, H. Fadda
semanticscholar   +1 more source

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

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