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  • Book
    Nigel Langley, Bozena Michniak-Kohn, David W. Osborne, editors.
    Summary: Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content. Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.

    Contents:
    Part I
    Critical Quality Attributes: 1. Rheological Characterization in the Development of Topical Drug Products
    2. In Vitro Release & Permeation Tests as Critical Quality Attributes in Topical Product Development
    3. Determination of Particle Size and Microstructure in Topical Pharmaceuticals
    Part II
    Role of API and Excipients: 4. Quality Assessment of API in Semisolid Topical Drug Products
    5. The Role of Excipients in the Microstructure of Topical Semi-solid Drug Products.
    Digital Access Springer 2019
  • Article
    Arnesen H, Heilo A, Jakobsen E, Ly B, Skaga E.
    Acta Med Scand. 1978;203(6):457-63.
    In a prospective trial, 42 medical patients with a history of deep vein thrombosis of less than five days were allocated at random to treatment with streptokinase or heparin. Only patients with extensive thromboses were included. Streptokinase was given in a loading dose of 250 000 IU and a maintenance dose of 100 000 IU/hour for 4 days as a mean. Heparin was given in a loading dose of 15 000 IU and a maintenance dose of 20 000-50 000 IU/day. The therapeutic results were evaluated by phlebography. Significant thrombolysis occurred in 71.4% of 21 patients treated with streptokinase and in 23.8% of the 21 heparin-treated patients. Using the chi2-test for overall association, this difference was statistically highly significant (p = 0.002). Three patients in each treatment group experienced major bleeding, two in each group requiring blood transfusions. Minor bleeding and slight rise in temperature were encountered more often in the streptokinase than in the heparin group. It is concluded that patients with acute deep vein thrombosis with proximal extension of the thrombus beyond the calf veins should be offered a therapeutic trial with streptokinase.
    Digital Access Access Options