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Showing posts with the label Open Access

Juniper Publishers - FDA 510 (k) Process- How To Get It Right The First Time?

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  Cancer Therapy & Oncology International Journal Abstract The medical devices that are designated to be marketed need to go through a clearance process set forth by FDA. The Premarket notification (PMN) or 510(k) is the most common regulatory pathway in US but poses many challenges to medical device manufacturers. FDA has cleared more than 1, 40,000 medical devices since 1976. This is a clearance process, and not an approval, for medical devices. 510(K) submission has a purpose, a process and should be well understood in order to avoid unnecessary delays and failures. Keywords: Medical device; Regulation; FDA; 510(K); Substantially Equivalent Abbreviations: FDA: Food and Drug Administration, PMA: Premarket Approval; SE: Substantially Equivalent; Introduction Getting a clearance letter from FDA on 510(K) for a medical device is a milestone and the ultimate goal for any medical device manufacturer, be it a small ...

Juniper Publishers - Encouraging Debut of Immunotherapy In Myeloma

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  Cancer Therapy & Oncology International Journal Abstract Multiple myeloma (MM) is a malignant disorder of antibody-producing clonal plasma cells. It is the second most common hematologic neoplasia worldwide [1]. Despite recent advances in myeloma treatment (high-dose chemotherapy followed by autologous stem cell transplantation, novel immunomodulatory drugs, and proteasome inhibitors); MM remains largely incurable with chemotherapy [2]. This is mostly due to the persistence of minimal residual disease (MRD), which leads to high relapse rates [2]. Furthermore, the prognosis of MM patients who become refractory to recently developed novel agents is very poor [1]. Abbreviations: MM: Multiple Myeloma; MRD: Minimal Residual Disease; PD-L1: Programmed Cell Death Ligand; MDSCs: Myeloid-Derived Suppressor Cells; ACT: Adoptive Cellular Therapy; SLAMF7: Signaling Lymphocyte Activating-Molecule Family Member 7; ADCC: Antibody-Dependent Cellular Cytotoxicity;...

Juniper Publishers - Pharmacists Perspective on Management of GBM

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  Cancer Therapy & Oncology International Journal Abstract Management of patients with glioblastoma multiform requires the concerted efforts of multiple healthcare professionals, including pharmacists. Pharmacists across different practice settings may encounter patients being treated for glioblastoma multiforme. The oral chemotherapy temozolomide is a standard of care forglioblastoma multiforme, with dosing regimens and cycles that require dispensing considerations by the pharmacist as well as careful patient monitoring. Pharmacists should be able to direct the patient with glioblastoma multiforme to payment assistance for this drug as well. Bevacizumab is used to increase progression-free survival in recurrent glioblastoma multiforme, and pharmacists can also aid in the dosing and monitoring of this agent. Sequelae of glioblastoma multiforme include brain edema, seizures, venous thromboembolism, depression, and fatigue. Management of sequelae may includ...

Juniper Publishers - Robotic Radical Partial Nephrectomy: Keep Pushing the Boundaries

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  Cancer Therapy & Oncology International Journal Mini Review Robotic Radical Partial Nephrectomy: Keep Pushing the Boundaries *Sanchia Goonewardene The Royal Free and UCL, UK Submission: October 26, 2016; Published: October 18, 2016 *Corresponding author: Sanchia Goonewardene, The Royal Free and UCL, NW3 2NG London, UK How to cite this article: Sanchia G. Robotic Radical Partial Nephrectomy: Keep Pushing the Boundaries. Canc Therapy & Oncol Int J. 2016; 2(1):555580. DOI: 10.19080/CTOIJ.2016.02.555580 Abstract The purpose of robotic radical partial nephrectomy is to ensure oncological clearance, whilst maintaining renal function. Main renal artery clamping during robotic partial nephrectomy (RPN) may compromise post-operative renal function [1]. Recent technologic advances mean resectional technique and outcomes can be improved. Specifically, robotic platforms, with robotic-assisted instrumentation, have ...

Juniper Publishers - Biphosphonate in Locally Advanced Breast Cancer

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  Cancer Therapy & Oncology International Journal Abstract Introduction and Objective: Clinical studies have demonstrated synergistic antitumor effects of chemotherapy (CT) and zoledronic acid (AZ). In the essay Neo - AZURE, to determine whether the addition of AZ to neoadjuvant chemotherapy gives compléte histological responses. We report a prospective evaluation comparing compléte pathological response between different subs - biomolecular groups. Methods: From 2012 to 2014, 432 patients received neoadjuvant chemotherapy + AZ. The main objective is the complete histologic response. Secondary endpoints were clinical response according to RECIST criteria, estimate the overall survival of patients targeted by the study, assess bone density before and at the end of chemotherapy, the side effects associated with the treatment protocol, and Quality life Results: histologic complete response with zoledronic acid was 40.13% .the higher in the subgro...