1,042 results match your criteria surrogate solid


A Primer on RECIST 1.1 for Oncologic Imaging in Clinical Drug Trials.

Radiol Imaging Cancer 2021 May;3(3):e210008

From the Department of Radiological Sciences, David Geffen School of Medicine at UCLA, 757 Westwood Plaza, Suite 1621, Los Angeles, CA 90095-1721 (K.R., M.D., V.S., A.G., R.D., J.G.); and Department of Radiology, Beth Israel Lahey Health, Burlington, Mass (M.B.A.).

Drug discovery and approval in oncology is mediated by the use of imaging to evaluate drug efficacy in clinical trials. Imaging is performed while patients receive therapy to evaluate their response to treatment. Response criteria, specifically Response Evaluation Criteria in Solid Tumors version 1. Read More

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Incorporating cytologic adequacy assessment into precision oncology workflow using telepathology: An institutional experience.

Cancer Cytopathol 2021 Apr 30. Epub 2021 Apr 30.

Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York.

Background: Tumor sample quality and quantity determine the success of somatic mutation analysis. Thus, a rapid on-site evaluation (ROSE) tumor cytology adequacy assessment was incorporated into the workflow of precision oncology at Weill Cornell Medicine in New York City. Optimal samples were obtained from 68 patients with metastatic cancer. Read More

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Tailored Limonene-Based Nanosized Microemulsion: Formulation, Physicochemical Characterization and Skin Irritation Assessment.

Adv Pharm Bull 2021 Feb 9;11(2):274-285. Epub 2020 Aug 9.

Department of Pharmaceutical Technology, Faculty of Pharmacy, Beirut Arab University, Beirut, Lebanon.

Microemulsion (ME) achieved progressing consequences on both the research and industry levels due to their distinctive properties. ME based-limonene system is considered as a surrogate to the traditional microemulsion composed of conventional oils. Thus, a novel microemulsion based on D-limonene and Gelucire® 44/12 had been designed and evaluated with assessing the factors affecting its physicochemical characteristics and in vivo skin irritation. Read More

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February 2021

Accelerated Solvent Extraction of Terpenes in Cannabis Coupled With Various Injection Techniques for GC-MS Analysis.

Front Chem 2021 1;9:619770. Epub 2021 Apr 1.

Verity Analytics, San Diego, CA, United States.

The cannabis market is expanding exponentially in the United States. As state-wide legalization increases, so do demands for analytical testing methodologies. One of the main tests conducted on cannabis products is the analysis for terpenes. Read More

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Safety of Surgical Fertility Preservation Procedures in Children Prior to Hematopoietic Stem Cell Transplant.

Transplant Cell Ther 2021 Apr 14. Epub 2021 Apr 14.

Division of Pediatric Oncology, Dana Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts; Department of Pediatrics, Harvard University Medical School, Boston, Massachusetts.

Long-term survival following hematopoietic stem cell transplant (HSCT) in childhood continues to improve, and patients are thus increasingly faced with the late effects of treatment. Infertility is very common for both males and females following HSCT and is one of the most distressing sequelae. Adoption and surrogate egg or sperm donation are possibilities for some patients, but post-HSCT reversal of gonadal failure is not possible. Read More

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Development of a chromatography-free method for high-throughput MS-based bioanalysis of therapeutic monoclonal antibodies.

Bioanalysis 2021 May 15;13(9):725-735. Epub 2021 Apr 15.

Analytical Chemistry Group, Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591-6707, USA.

Our objective was to test the feasibility of developing an LC-free, MS-based approach for high-throughput bioanalysis of humanized therapeutic monoclonal antibodies. A universal tryptic peptide from human IgG1, IgG3 and IgG4 was selected as the surrogate peptide for quantitation. After tryptic digestion, the surrogate peptide was fractionated via solid-phase extraction before being subjected to direct infusion-based MS/MS analysis. Read More

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Benchtop NIR method development for continuous manufacturing scale to enable efficient PAT application for solid oral dosage form.

Int J Pharm 2021 May 9;601:120581. Epub 2021 Apr 9.

Worldwide Research and Development, Pfizer Inc., Groton, CT 06340, USA.

A Near Infrared (NIR) method was developed using a small benchtop feed frame system to quantify Saccharin potency in a powder blend during continuous manufacturing process. A 15-point Design of Experiments (DoE) was created based on the NIR spectral response and compositions of the formulation to develop a calibration set. The calibration set was designed to create compositional and raw material lots variation using minimum resources. Read More

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Translational pharmacokinetic-pharmacodynamic modeling of preclinical and clinical data of the oral MET inhibitor tepotinib to determine the recommended phase II dose.

CPT Pharmacometrics Syst Pharmacol 2021 Apr 5. Epub 2021 Apr 5.

Merck KGaA, Darmstadt, Germany.

Tepotinib is a highly selective and potent MET inhibitor in development for the treatment of patients with solid tumors. Given the favorable tolerability and safety profiles up to the maximum tested dose in the first-in-human (FIH) trial, an efficacy-driven translational modeling approach was proposed to establish the recommended phase II dose (RP2D). To study the in vivo pharmacokinetics (PKs)/target inhibition/tumor growth inhibition relationship, a subcutaneous KP-4 pancreatic cell-line xenograft model in mice with sensitivity to MET pathway inhibition was selected as a surrogate tumor model. Read More

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A high concentration of TGF-β correlates with opportunistic infection in liver and kidney transplantation.

Hum Immunol 2021 Jun 2;82(6):414-421. Epub 2021 Apr 2.

Department of Immunology, University Clinical Hospital Virgen de la Arrixaca - Biomedical Research Institute of Murcia (IMIB), Murcia, Spain.

Transforming growth factor-β (TGF-β) has been associated with numerous human infections, but its role in the occurrence of opportunistic infection (OI) after solid organ transplantation remains unexplored. This study aimed to assess the utility of the TGF-β following in vitro stimulation of whole peripheral blood (WPB) as a surrogate biomarker of post-transplant OI in a cohort of liver and kidney recipients. Thirty liver and thirty-one kidney transplant recipients were recruited to be prospectively monitored for one-year post-transplantation. Read More

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Exploration of modified progression-free survival as a novel surrogate endpoint for overall survival in immuno-oncology trials.

J Immunother Cancer 2021 Apr;9(4)

Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, P. R. China

Background: Progression-free survival (PFS) exhibits suboptimal performance as the surrogate endpoint for overall survival (OS) in trials studying immune checkpoint inhibitors (ICIs). Here we propose a novel surrogate endpoint, modified PFS (mPFS), which omits the events of disease progression (but not deaths) within 3 months after randomization.

Methods: PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for randomized trials studying ICIs in advanced solid tumors with available PFS and OS data up to May 2020. Read More

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Tumor Cellularity and Infiltrating Lymphocytes (CelTIL) as a Survival Surrogate in HER2-Positive Breast Cancer.

J Natl Cancer Inst 2021 Mar 31. Epub 2021 Mar 31.

Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.

In early-stage HER2-positive breast cancer, biomarkers that guide de-escalation and/or escalation of systemic therapy are needed. CelTIL score is a novel, combined biomarker based on stromal tumor-infiltrating lymphocytes and tumor cellularity and determined in tumor biopsies at week 2 of anti-HER2 therapy only. We evaluated the prognostic value of CelTIL in 196 patients with early-stage HER2-positive disease treated with standard trastuzumab-based chemotherapy in the NeoALTTO phase III trial. Read More

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Clinical and Metabolic Characteristics of Non-Alcoholic Fatty Liver Disease Patients in Saudi Arabia: Data from the Systematic Observatory Liver Disease (SOLID) Registry.

Diabetes Metab Syndr Obes 2021 16;14:1167-1175. Epub 2021 Mar 16.

Liver Transplant Center, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia.

Background And Aims: The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing in Saudi Arabia (SA), but descriptions of the clinical and metabolic characteristics of these patients are limited. The present study aims to fill this gap.

Methods: Demographic, clinical, and laboratory data of all NAFLD patients from 2009 to 2019 were retrieved from the Systematic Observatory Liver Disease Registry (SOLID) [n=832 (337 males; 495 females); mean (± standard deviation, SD) age was 42. Read More

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Spatially Resolved Emission Factors to Reduce Uncertainties in Air Pollutant Emission Estimates from the Residential Sector.

Environ Sci Technol 2021 04 15;55(8):4483-4493. Epub 2021 Mar 15.

Laboratory for Earth Surface Process, College of Urban and Environmental Sciences, Peking University, Beijing 100871, China.

The residential sector is a major source of air pollutant emission inventory uncertainties. A nationwide field emission measurement campaign was conducted in rural China to evaluate the variabilities of realistic emission factors (EFs) from indoor solid fuel combustion. For a total of 1313 burning events, the overall average EFs (±standard deviation) of PM were 8. Read More

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CAR-T cell therapy: practical guide to routine laboratory monitoring.

Pathology 2021 Apr 5;53(3):408-415. Epub 2021 Mar 5.

Clinical Hematology, The Royal Melbourne Hospital and Peter MacCallum Cancer Centre, Melbourne, Vic, Australia; Centre of Excellence in Cellular Immunotherapy, Peter MacCallum Cancer Centre, Melbourne, Vic, Australia; Division of Blood Cells and Blood Cancer, The Walter and Eliza Hall Institute, Parkville, Vic, Australia. Electronic address:

Chimeric antigen receptor (CAR)-T cell therapy is a genetically-modified cellular immunotherapy that has a current established role in the treatment of relapsed/refractory B-cell acute lymphoblastic leukaemia and diffuse large B-cell lymphoma, with emerging utility in a spectrum of other haematological and solid organ malignancies. It is associated with a number of characteristic toxicities, most notably cytokine release syndrome and neurotoxicity, for which laboratory testing can aid in the prediction of severity and in monitoring. Other toxicities, such as cytopenias/marrow hypoplasia, hypogammagloblinaemia and delayed immune reconstitution are recognised and require monitoring due to the implications for infection risk and prophylaxis. Read More

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Racial disparities in immune-related adverse events of immune checkpoint inhibitors and association with survival based on clinical and biochemical responses.

World J Clin Oncol 2021 Feb;12(2):103-114

Department of Hematology/Oncology, MedStar Washington Hospital Center, Washington, DC 20010, United States.

Background: Immune checkpoint inhibitors (ICPi) cause various immune-related adverse events irAE) with thyroid dysfunction as a commonly reported abnormality. There is increasing evidence showing positive association with development of irAE and survival. However, prior trials with ICPi had underrepresentation of minorities with < 5% African Americans. Read More

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February 2021

Neoadjuvant treatment of stage IIIA-N2 in -Mutant/-rearranged non-small cell lung cancer.

Transl Lung Cancer Res 2021 Jan;10(1):607-621

Department of Medical Oncology, Hospital Clínic, Barcelona, Spain.

Defining the optimal neoadjuvant strategy in early-stage and locoregional (N2) oncogenic-driven lung cancer remains a major challenge for the scientific community. Whereas significant advances have been achieved with the use of personalized medicine and targeted therapies in advanced stages, we are still far from translating the same magnitude of benefits into an earlier-stage disease. Perioperative strategies with neoadjuvant and adjuvant tyrosine kinase inhibitors in patients with and gene alterations have yielded mixed results and further biomarker-driven trials are needed to shed more light on the significance of inhibiting the oncogenic signaling addiction at earlier stages of the disease and the conceivable value of incorporating more potent targeted inhibitors in this setting. Read More

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January 2021

Induction treatment in patients with stage III non-small cell lung cancer.

Transl Lung Cancer Res 2021 Jan;10(1):539-554

Department of Medical Oncology, Catalan Institute of Oncology, Barcelona, Spain.

Stage III non-small cell lung cancer (NSCLC) comprises a highly heterogeneous group of patients defined according to the extent and localization of disease. Patients with discrete N2 involvement identified preoperatively with resectable disease are candidates for multimodal therapy either with definitive chemoradiation therapy, induction chemotherapy, or chemoradiotherapy (CTRT) followed by surgery. Neoadjuvant chemotherapy has yielded comparable survival benefit to adjuvant chemotherapy in patients with stage II-III disease and may allow for downstaging the tumor or the lymph nodes, an earlier delivery of systemic treatment, and better compliance to systemic therapy. Read More

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January 2021

Electrical Source Imaging in Freely Moving Rats: Evaluation of a 12-Electrode Cortical Electroencephalography System.

Front Neuroinform 2020 25;14:589228. Epub 2021 Jan 25.

National Institute of Mental Health, Klecany, Czechia.

This work presents and evaluates a 12-electrode intracranial electroencephalography system developed at the National Institute of Mental Health (Klecany, Czech Republic) in terms of an electrical source imaging (ESI) technique in rats. The electrode system was originally designed for translational research purposes. This study demonstrates that it is also possible to use this well-established system for ESI, and estimates its precision, accuracy, and limitations. Read More

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January 2021

Iron Acquisition of Urinary Tract Infection Involves Pathogenicity in .

Microorganisms 2021 Feb 2;9(2). Epub 2021 Feb 2.

Institute of Molecular Medicine, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.

Uropathogenic (UPEC) is a major bacterial pathogen that causes urinary tract infections (UTIs). The mouse is an available UTI model for studying the pathogenicity; however, represents as an alternative surrogate host with the capacity for high-throughput analysis. Then, we established a simple assay for a UPEC infection model with for large-scale screening. Read More

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February 2021

Surrogate based Global Sensitivity Analysis of ADM1-based Anaerobic Digestion Model.

Authors:
A Trucchia L Frunzo

J Environ Manage 2021 Mar 10;282:111456. Epub 2021 Jan 10.

Department of Mathematics and applications "R. Caccioppoli", via Cintia 1, 91126, Naples, Italy. Electronic address:

In order to calibrate the model parameters, Sensitivity Analysis routines are mandatory to rank the parameters by their relevance and fix to nominal values the least influential factors. Despite the high number of works based on ADM1, very few are related to sensitivity analysis. In this study Global Sensitivity Analysis (GSA) and Uncertainty Quantification (UQ) for an ADM1-based Anaerobic Digestion Model have been performed. Read More

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Biomarker and surrogate development in vascularised composite allograft transplantation: Current progress and future challenges.

J Plast Reconstr Aesthet Surg 2021 Apr 2;74(4):711-717. Epub 2020 Dec 2.

Department of Plastic, Reconstructive and Hand Surgery, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford OX3 9DU, Oxford, United Kingdom. Electronic address:

Vascularised composite allograft (VCA) transplantation is now a feasible reconstructive option for patients who have suffered significant soft tissue injuries. However, despite numerous technical advances in the field over two decades, a number of challenges remain, not least the management of transplant rejection. Part of the difficulty faced by clinicians is the early recognition and prevention of acute rejection episodes. Read More

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Utilization of greenhouse effect for the treatment of COVID-19 contaminated disposable waste - A simple technology for developing countries.

Int J Hyg Environ Health 2021 03 8;232:113690. Epub 2021 Jan 8.

Water Resources Engineering, Lund University, Lund, Sweden.

Countries with abundant solar radiation have the potential to invest in simple technologies for deactivation of many bacteria and viruses in medical solid waste. In addition to the traditional Infection and Prevention Control (IPC) measures, these simple technologies contribute to better protection of health care workers in countries with compromised solid management schemes. Monitoring of temperature, relative humidity and ultraviolet inside containers soundly designed to collect disposal infectious waste illustrated to deactivate several viruses and bacteria. Read More

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Palladium-Catalyzed Cascade Carbonylative Synthesis of 1,2,4-Triazol-3-ones from Hydrazonoyl Chlorides and NaN.

Org Lett 2021 Feb 12;23(3):974-978. Epub 2021 Jan 12.

Leibniz-Institut für Katalyse e. V. an der Universität Rostock, Albert-Einstein-Straβe 29a, 18059 Rostock, Germany.

A palladium-catalyzed three-component carbonylative reaction for the synthesis of 3-1,2,4-triazol-3-ones from hydrazonoyl chlorides and NaN has been achieved. The reaction presumably proceeds through a cascade carbonylation, acyl azide formation, Curtius rearrangement, and intramolecular nucleophilic addition sequence. A wide variety of structurally diverse 3-1,2,4-triazol-3-ones were constructed in moderate to excellent yields. Read More

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February 2021

Sustainable polypyrrole-based magnetic-microextraction of phthalates from jellies and apple-based beverages prior to tandem mass spectrometry analysis.

J Chromatogr A 2021 Jan 29;1637:461858. Epub 2020 Dec 29.

Departamento de Química, Unidad Departamental de Química Analítica, Facultad de Ciencias, Universidad de La Laguna (ULL). Avda. Astrofísico Fco. Sánchez, s/n°. 38206 San Cristóbal de La Laguna, España. Electronic address:

Synthesised polypyrrole-coated FeO magnetic nanoparticles have been successfully characterised and applied as sorbent for the magnetic-micro-dispersive solid-phase extraction of eleven phthalic acid esters from jelly and apple-based beverage matrices widely consumed by the population and, especially, by children. Sorbent was synthesised through chemical coprecipitation and subsequently characterised by different techniques. The influence of several parameters on the extraction efficiency was exhaustively evaluated using a step-by-step strategy. Read More

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January 2021

Experimental analysis of the influence of cortical bone layers and bone quantity on implant primary stability.

J Biol Regul Homeost Agents 2020 Nov-Dec;34(6 Suppl. 3):47-57

Advanced Oral Surgery Unit, Department of Dentistry, Vita Salute University, San Raffaele Hospital, Milano, Italy.

The systematic analysis of parameters impacting implant primary stability is difficult to achieve with human cadavers or animal models, particularly for complex trans-sinus procedures to determine the effects of cortical layers and bone engagement on implant stability before and after a simulated load in vitro. Solid rigid polyurethane blocks, partially intersected by an 8-mm-thick space, were created to imitate tri-cortical situations, the presence of the sinus cavity, and the posterior maxilla with different degrees of bone atrophy. Implants were inserted through the cavity at an angle of 30˚ (scenarios 1 and 2) to imitate the clinical protocol. Read More

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February 2021

Bioethical issues and legal frameworks of surrogacy: A global perspective about the right to health and dignity.

Eur J Obstet Gynecol Reprod Biol 2021 Mar 15;258:1-8. Epub 2020 Dec 15.

Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, Sapienza University of Rome, Italy. Electronic address:

Modern advances in assisted reproduction technology (ART) have disrupted the traditional concept of parenthood. Every year, thousands of people travel abroad from their home countries in order to circumvent restrictive legislation or to benefit from lower fees. In a similar context, surrogacy raises many bioethical and legal issues. Read More

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Radiological response to nivolumab in patients with hepatocellular carcinoma: A multicenter analysis of real-life practice.

Eur J Radiol 2021 Feb 17;135:109484. Epub 2020 Dec 17.

Barcelona Clínic Liver Cancer (BCLC) Group, Liver Unit, Hospital Clínic of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. Electronic address:

Background And Aims: Immune-checkpoint inhibitors are effective in many advanced tumors. However, there is scarce information regarding the radiological response to these agents in hepatocellular carcinoma outside clinical trials. We aimed to describe the radiological response in a retrospective cohort of hepatocellular carcinoma patients treated with nivolumab and to analyze the radiological evolution according to tumor response at first post-treatment radiological assessment. Read More

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February 2021

Quantification of nivolumab in human plasma by LC-MS/HRMS and LC-MS/MS, comparison with ELISA.

Talanta 2021 Mar 12;224:121889. Epub 2020 Nov 12.

Laboratoire de Biochimie et Pharmaco-toxicologie, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, F-69495, Pierre Bénite, France; EMR 3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine Lyon-Sud, F-69921, Oullins, France; Laboratoire de Toxicologie, Faculté de Pharmacie ISPBL, Université Lyon 1, F-69373, Lyon, France. Electronic address:

Nivolumab is a fully human immunoglobulin G4 used for the treatment of several advanced solid cancers as immune checkpoint inhibitors. There are some challenges for the quantification of mAb in plasma because IgG are present intrinsically in complex biologic matrices and this determination must be based on reliable, selective, and accurate analytical methods. This study described two validated methods carried out in two separate laboratories, one developed with a triple quadrupole tandem mass spectrometry (LC-MS/MS) and the other with high resolution mass spectrometry with an orbitrap system (LC-MS/HRMS). Read More

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Assessment of the Oxidative Desulfurization of Middle Distillate Surrogate Fuels with Spectroscopic Techniques.

J Anal Methods Chem 2020 9;2020:8876082. Epub 2020 Dec 9.

Laboratory of Fuels Technology and Lubricants, School of Chemical Engineering, National Technical University of Athens, Athens, Greece.

The oxidative desulfurization of five (5) model sulfur compounds and eleven (11) surrogate blends was investigated using the hydrogen peroxide (HO)-acetic acid (CHCOOH) system. Consequently, extractive desulfurization was carried out using conventional solvents. The model sulfur compounds, as well as the solvent, are present in petroleum middle distillates. Read More

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December 2020

Population pharmacokinetics of ganciclovir and valganciclovir in paediatric solid organ and stem cell transplant recipients.

Br J Clin Pharmacol 2020 Dec 29. Epub 2020 Dec 29.

Clinical Pharmacology Unit, CHU Sainte-Justine, Montreal, Quebec, Canada.

Aims: Ganciclovir (GCV) and its prodrug valganciclovir (VGCV) are first-line agents to prevent and treat cytomegalovirus in transplant recipients. There is high pharmacokinetic (PK) interindividual variability and PK data are scarce, especially in paediatric stem cell transplant (SCT) recipients. We sought to determine the optimal GCV and VGCV dosing in transplanted children. Read More

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December 2020