Publications by authors named "Lg Shane"

Policymakers in the United States (US) recommend coronavirus disease 2019 (COVID-19) vaccination with a monovalent 2023-2024 vaccine formulation based on the Omicron XBB.1.5 variant.

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Article Synopsis
  • * While tendering can contain costs, it risks reducing market competition, potentially leading to drug shortages and alternatives that may be less effective or riskier for patients.
  • * The review aims to analyze the tendering process and its effects on drug availability, along with exploring the role of biosimilars—lower-cost alternatives to branded biologics—in mitigating health care expenses and their varying integration through tendering worldwide.
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Background: Patients with cancer have an elevated risk of venous thromboembolism. Importantly, patients with cancer, who have metastatic disease, renal insufficiency, or are receiving anticancer therapy, have an even higher risk of a recurrent event. Similarly, the risk of recurrent venous thromboembolism is higher than the risk of an initial event.

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Biosimilar drugs are highly similar to an originator (reference) biologic, with no clinically meaningful differences in terms of safety or efficacy. As biosimilars offer the potential for lower acquisition costs versus the originator biologic, evaluating the economic implications of the introduction of biosimilars is of interest. Budget impact analysis (BIA) is a commonly used methodology.

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Background: International guidelines recommend extended duration secondary prophylaxis in cancer patients who develop primary venous thromboembolism (VTE). Agent selection is guided in part by one large randomized trial (i.e.

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Objective: To review the scientific and regulatory aspects of biosimilar development and practical considerations for the use of biosimilars that are relevant to pharmacists.

Data Sources: Literature searches of PubMed and congress abstracts for publications pertaining to biosimilars were conducted from January 2016 to January 2017. Individual drug company web pages and governmental, regulatory, and other agency websites were also reviewed.

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Background: Patients with cancer are at increased risk of venous thromboembolism (VTE) and the risk is further elevated after a primary VTE. To reduce the risk of recurrent events, extended prophylaxis with vitamin K antagonists (VKA) is available for use. However, in a large randomized trial (Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer [CLOT]; Lee et al), extended duration dalteparin reduced the relative risk of recurrent VTE by 52% compared to VKA (=0.

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Background: Despite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it.

Objectives: The objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weight (quantity and quality) of available evidence.

Methods: MEDLINE, Embase, and ISI Web of Science were searched to September 2015.

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Objective: To understand the levels of awareness, usage, and knowledge of biosimilars among patients, caregivers, and the general population in the US and the European Union; perceptions of biosimilars compared to originator biologics; perceived benefits and drawbacks of clinical trials; and whether advocacy groups impact patients' willingness to try a biosimilar.

Methods: An international survey was conducted which contained up to 56 closed-ended (requiring yes/no or ranking answers) and open-ended questions, depending on the population assigned. The survey was divided into distinct sections, including medication-class awareness, usage, and knowledge about biologic and biosimilar therapies; perceptions of clinical trials; and involvement in advocacy groups.

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Objective: To measure the economic cost of rotavirus-associated diarrhea for a selected group of families, in a nonexperimental setting, and to estimate the factors that influence these costs.

Design: Use and other socioeconomic data from a family survey (the Pediatric Rotavirus Epidemiology Study for Immunization) of children who tested positive for rotavirus were collected for the metropolitan Toronto and Peel regions of Ontario during the rotavirus season of 1997-1998. Service costs were estimated from provider data.

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Objectives: To provide a qualitative and quantitative review of the published literature that examines the relationship between reliable markers of insulin resistance and coronary artery disease risk factors (plasma glucose, triglycerides, high density lipoprotein cholesterol, hypertension, obesity, low density lipoprotein size) and outcomes (as related to ischemic heart disease) in populations with and without type 2 diabetes.

Methods: The MEDLINE database was searched (January 1966 to April 2000). Additional references were identified from bibliographies of retrieved articles.

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