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17,095 results
  • Quality and Equivalence of Topical Products: A Critical Appraisal. [Review]
    Eur J Pharm Sci 2019; :105082Miranda M, Cardoso C, Vitorino C
  • The approval of topical generic products is essentially governed by clinical endpoint studies. Is this the most efficient approach to document bioequivalence in these particular dosage forms? This issue has sparkled multiple discussions among different stakeholders - academia, industry and several regulatory agencies - in the active pursuit for new and robust surrogate methodologies. This mini re…
  • Is Bioequivalence a Sufficient Measure of Equivalence? [Journal Article]
    J Leg Med 2019 Jul-Sep; 39(3):247-261Holman A
  • This article reviews the U.S. Food and Drug Administration (FDA) regulation of generic medications-specifically, the use of bioequivalence to compare generic and brand prescriptions. New or "brand" drugs are subjected to extensive review by the FDA before they can be marketed to the public. Generics, which are posited to be identical to brands, are subject to a less extensive review process and m…
  • Facile fabrication of highly exothermic CuO@Al nanothermites via self‒assembly approach. [Journal Article]
    Nanotechnology 2019Wang Q, Ma Y, … Yang W
  • CuO@Al nanothermites with Al shell and CuO core were successfully fabricated via a simple self‒assembly route. The composition and morphology of CuO@Al nanothermites were analyzed by X‒ray diffraction (XRD) and field‒emission scanning electron microscopy (FESEM) in detail. When the equivalence ratio was 1.0, the heat output of CuO@Al nanothermites reached 1252 J/g, which was significantly larger t…
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