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Quantitative determination of Nebivolol Hydrochloride and Rosuvastatin Calcium in laboratory prepared mixture by robust, high-performance liquid chromatographic method

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Discover Chemistry 2025年第1期2卷 1-16页

作者： Bolla, Sandeep Boggula, Narender Department of Statistical Programming Fortrea (Formerly LabCorp) Durham USA Department of Pharmaceutical Chemistry Omega College of Pharmacy Hyderabad India

A robust and eco-friendly high-performance liquid chromatographic (HPLC) method has been developed and validated to quantify Nebivolol Hydrochloride and Rosuvastatin Calcium in a laboratory-prepared mixture, following ICH guidelines. Utilizing a Shimpack ODS C18 column with a mobile phase consisting of Methanol, Acetonitrile, and phosphate buffer (pH 3.5, adjusted with ortho-phosphoric acid) in a 40:20:40 (v/v/v) ratio, the method achieved effective separation and detection at 281 nm. The assay demonstrated excellent linearity, precision, and accuracy for both drugs, with retention times of 2.455 min for Nebivolol and 6.197 min for Rosuvastatin. Forced degradation studies under acidic, basic, oxidative, thermal, and photolytic conditions revealed the method’s stability-indicating capability, with distinct separation of degradation products. The method’s environmental impact was assessed using the Analytical Eco Scale, AGREE metrics, and GAPI (Green Analytical Procedure Index), yielding favorable greenness scores (AES: 69, AGREE: 0.61), signifying moderate adherence to green analytical chemistry principles. This validated method is reliable for routine analysis and quality control, making it applicable to pharmaceutical and analytical laboratories.

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Dimension reduction with expectation of conditional difference

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statistical Theory and Related Fields 2023年第3期7卷 188-201页

作者： Wenhui Sheng Qingcong Yuan Department of Mathematical and Statistical Sciences Marquette UniversityMilwaukeeWIUSA Biostatistics and Programming SanofiUSBridgewaterNJUSA

In this article,we introduce a flexible model-free approach to sufficient dimension reduction analysis using the expectation of conditional difference *** any strict conditions,such as linearity condition or constant covariance condition,the method estimates the central subspace exhaustively and efficiently under linear or nonlinear relationships between response and *** method is especially meaningful when the response is *** also studiedthe√n-consistency and asymptotic normality of the *** efficacy of our method is demonstrated through both simulations and a real data analysis.

关键词： Central subspace expectation of conditionaldifference measure sufficientdimension reduction

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Recursive Neyman Algorithm for Optimum Sample Allocation under Box Constraints on Sample Sizes in Strata

arXiv

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arXiv 2023年

作者： Wesolowski, Jacek Wieczorkowski, Robert Wójciak, Wojciech Programming Coordination of Statistical Surveys and Registers Department Statistics Poland Aleja Niepodleglości 208 Warsaw00-925 Poland Faculty of Mathematics and Information Science Warsaw University of Technology ul. Koszykowa 75 Warsaw00-662 Poland

The optimum sample allocation in stratified sampling is one of the basic issues of survey methodology. It is a procedure of dividing the overall sample size into strata sample sizes in such a way that for given sampling designs in strata the variance of the stratified π estimator of the population total (or mean) for a given study variable assumes its minimum. In this work, we consider the optimum allocation of a sample, under lower and upper bounds imposed jointly on sample sizes in strata. We are concerned with the variance function of some generic form that, in particular, covers the case of the simple random sampling without replacement in strata. The goal of this paper is twofold. First, we establish (using the Karush-Kuhn-Tucker conditions) a generic form of the optimal solution, the so-called optimality conditions. Second, based on the established optimality conditions, we derive an efficient recursive algorithm, named RNABOX, which solves the allocation problem under study. The RNABOX can be viewed as a generalization of the classical recursive Neyman allocation algorithm, a popular tool for optimum allocation when only upper bounds are imposed on sample strata-sizes. We implement RNABOX in R as a part of our package stratallo which is available from the Comprehensive R Archive Network (CRAN) repository. Copyright © 2023, The Authors. All rights reserved.

关键词： Sampling

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Stability-indicating liquid chromatographic method for the simultaneous estimation of colchicine and rosuvastatin in combination

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Essential Chem 2025年第1期2卷

作者： Sandeep Bolla Narender Boggula a Department of Statistical Programming Fortrea Durham North Carolina USA b Department of Pharmaceutical Chemistry Omega College of Pharmacy Hyderabad India

ABSTRACTThis study focuses on developing and validating a robust, reliable, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous quantification of Colchicine and Rosuvastatin in bulk and synthetic mixture. The developed method is designed to meet International Council for Harmonization (ICH) guidelines for stability-indicating assays. The mobile phase consisted of buffer (pH adjusted to 4.0 with ortho-phosphoric acid): methanol: acetonitrile: in a 50:30:20 (v/v/v) ratio, and separation was performed on a Shim-pack ODS C18 (250 mm × 4.6 mm, 5 µm) column. The method was validated for specificity, linearity, precision, accuracy, and robustness. Forced degradation studies were performed under acidic, basic, oxidative, photolytic, and thermal stress conditions. Results showed that the method is selective for the active ingredients and degradation products, with retention times for Colchicine and Rosuvastatin being approximately 5.91 and 8.44 minutes, respectively. Moreover, the greenness profile for the proposed method was assessed utilizing the analytical greenness (AGREE) metrics with a score of the later one equals to 0.61 that indicated the greenness evaluation of the method. This method can be effectively used for routine quality control and stability testing.

关键词： Colchicine and rosuvastatin COVID-19 HPLC method stability indicating method UV spectroscopy

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Ex utero intrapartum therapy in infants with congenital diaphragmatic hernia:a propensity score matching analysis

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World Journal of Pediatric Surgery 2022年第4期5卷 267-274页

作者： Yunlong Zhao Ying Wang Chao Liu Yulin Jiang Yandong Wei Hua Meng Shan Jian Xiting Zhu Lijian Pei Xiaochen Bai Feng Feng Yan Lv Xiya Zhou Qingwei Qi Jingna Li Lishuang Ma Peking Union Medical College Graduate School BeijingChina Department of Neonatal Surgery Children’s Hospital of Capital Institute of PediatricsCapital Institute of PediatricsBeijingChina Department of Obstetrics Peking Union Medical College HospitalBeijingChina Department of Ultrasound Peking Union Medical College HospitalBeijingChina Department of Pediatrics Peking Union Medical College HospitalBeijingChina Department of Biostatistics and Statistical Programming Everest Clinical Research CorporationBeijingChina Department of Anesthesiology Peking Union Medical College HospitalBeijingChina Department of Pediatrics Beijing Obstetrics and Gynecology HospitalCapital Medical UniversityBeijingChina Department of Radiology Peking Union Medical College HospitalBeijingChina

Objective Previous studies have shown that ex utero intrapartum therapy(EXIT)is safe and feasible for newborns with congenital diaphragmatic hernia(CDH).This study reports our experience with EXIT in fetuses with CDH in an attempt to explore the efficacy of EXIT on the survival rate of this *** A retrospective analysis of the clinical data of 116 children with CDH was *** children were assigned to EXIT and non-EXIT *** score matching(PSM)toward clinical data was performed,and the clinical characteristics and outcomes were *** survival at discharge as the main outcome,logistic regression analysis was carried out to explore the efficacy of EXIT on *** During the study period,30 of 116 children received *** PSM,the survival rates of the EXIT group and the non-EXIT group were 82.76%(24/29)and 48.28%(14/29),respectively(p=0.006).EXIT(OR=0.083,95%CI=0.013to 0.525,p=0.008),liver herniation(OR=16.955,95%CI=2.342 to 122.767,p=0.005),and gestational age at diagnosis(OR=0.662,95%CI=0.497 to 0.881,p=0.005)were independent mortality-related risk factors of all children with ***-nine of 116 children underwent *** PSM,the postoperative survival rates of the EXIT group and non-EXIT group were 84.6%(22/26)and 76.9%(20/26),respectively(p=0.754).Liver herniation(OR=10.451,95%CI=1.641 to 66.544,p=0.013)and gestational age at diagnosis(OR=0.736,95%CI=0.577 to 0.938,p=0.013)were independent mortality-related risk factors of children after *** EXIT can be performed safely for selected prenatally diagnosed CDH neonates with potentially better survival and does not cause more maternal complications compared with traditional cesarean section.

关键词： hernia diagnosis congenital

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On multi-armed bandit designs for dose-finding clinical trials

The Journal of Machine Learning Research

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The Journal of Machine Learning Research 2021年第1期22卷 686-723页

作者： Maryam Aziz Emilie Kaufmann Marie-Karelle Riviere Spotify NYC Univ. Lille CNRS Inria Centrale Lille UMR 9189 CRIStAL Lille France Statistical Methodology Group Biostatistics and Programming department Sanofi R&D Chilly-Mazarin France

We study the problem of finding the optimal dosage in early stage clinical trials through the multiarmed bandit lens. We advocate the use of the Thompson Sampling principle, a flexible algorithm that can accommodate different types of monotonicity assumptions on the toxicity and efficacy of the doses. For the simplest version of Thompson Sampling, based on a uniform prior distribution for each dose, we provide finite-time upper bounds on the number of sub-optimal dose selections, which is unprecedented for dose-finding algorithms. Through a large simulation study, we then show that variants of Thompson Sampling based on more sophisticated prior distributions outperform state-of-the-art dose identification algorithms in different types of dose-finding studies that occur in phase I or phase I/II trials.

关键词： multi-armed bandits adaptive clinical trials phase I clinical trials phase I/II clinical trials Thompson sampling Bayesian methods

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7 Phase 3 Trial of an Oral CXCR4 Antagonist, Mavorixafor, for Treatment of Patients With WHIM Syndrome: Preliminary Results From Ongoing Open-Label Extension Period of Continuous Mavorixafor Treatment

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Clinical Immunology 2024年 262卷 109949-109949页

作者： Tarrant, Teresa Badolato, Raffaele Donadieu, Jean Dubuc, Susan Hu, Yanping Jiang, Honghua Li, Sunny Steiner, Deborah Yan, Tina Arbet-Engels, Christophe Associate Professor of Medicine Rheumatology and Immunology/Division of Rheumatology and Immunology Department of Medicine Duke University Durham NC USA Full Professor of Pediatrics Chair of Pediatrics ASST Spedali Civili Brescia/Department of Clinical and Experimental Sciences University of Brescia & ASST Spedali Civili Brescia Italy Pediatric Physician/CHU Paris Est - Hôpital d’Enfants Armand-Trousseau Paris France Senior Director Pharmacovigilance & Risk Management/X4 Pharmaceuticals Boston MA USA Director Clinical Research/X4 Pharmaceuticals Boston MA USA Senior Director Biostatistics/X4 Pharmaceuticals Boston MA USA Senior Director Statistical Programming/X4 Pharmaceuticals Boston MA USA Vice President Clinical Development/X4 Pharmaceuticals Boston MA USA Director Statistical Programming/X4 Pharmaceuticals Boston MA USA Chief Medical Officer/X4 Pharmaceuticals Boston MA USA

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Bayesian dose-regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics

arXiv

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arXiv 2020年

作者： Gerard, Emma Zohar, Sarah Thai, Hoai-Thu Lorenzato, Christelle Riviere, Marie-Karelle Ursino, Moreno Centre de Recherche des Cordeliers Sorbonne Université Inserm Université de Paris ParisF-75006 France Oncology biostatistics Biostatistics and Programming department Sanofi R&D Vitry-sur-Seine France Statistical Methodology Group Biostatistics and Programming department Sanofi R&D Chilly-Mazarin France Translation Disease Modeling Digital and Data Science Sanofi R&D Chilly-Mazarin France F-CRIN PARTNERS platform AP-HP Université de Paris Paris France

Phase I dose-finding trials in oncology seek to find the maximum tolerated dose (MTD) of a drug under a specific schedule. Evaluating drug-schedules aims at improving treatment safety while maintaining efficacy. However, while we can reasonably assume that toxicity increases with the dose for cytotoxic drugs, the relationship between toxicity and multiple schedules remains elusive. We proposed a Bayesian dose-regimen assessment method (DRtox) using pharmacokinetics/pharmacodynamics (PK/PD) information to estimate the maximum tolerated dose-regimen (MTD-regimen), at the end of the dose-escalation stage of a trial to be recommended for the next phase. We modeled the binary toxicity via a PD endpoint and estimated the dose-regimen toxicity relationship through the integration of a dose-regimen PD model and a PD toxicity model. For the dose-regimen PD model, we considered nonlinear mixed-effects models, and for the PD toxicity model, we proposed the following two Bayesian approaches: a logistic model and a hierarchical model. We evaluated the operating characteristics of the DRtox through simulation studies under various scenarios. The results showed that our method outperforms traditional model-based designs demonstrating a higher percentage of correctly selecting the MTD-regimen. Moreover, the inclusion of PK/PD information in the DRtox helped provide more precise estimates for the entire dose-regimen toxicity curve;therefore the DRtox may recommend alternative untested regimens for expansion cohorts. The DRtox should be applied at the end of the dose-escalation stage of an ongoing trial for patients with relapsed or refractory acute myeloid leukemia (NCT03594955) once all toxicity and PK/PD data are collected. © 2020, CC-BY.

关键词： Toxicity

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Thermodynamics of optical bloch equations

arXiv

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arXiv 2020年

作者： Elouard, Cyril Herrera-Martí, David Esposito, Massimiliano Auffèves, Alexia Department of Physics and Astronomy University of Rochester RochesterNY14627 United States Atos Centre for Excellence in Performance Programming 1 rue de Provence Echirolles38130 France Complex Systems and Statistical Mechanics Department of Physics and Materials Science University of Luxembourg LuxembourgL-1511 Luxembourg CNRS Université Grenoble Alpes Institut Néel GrenobleF-38042 France

Optical Bloch Equations (OBE) describe the coherent exchange of energy between a quantum bit (qubit) and a quasi-resonant driving field in the presence of a thermal bath. Despite it being an ubiquitous process in quantum technologies, a sound thermodynamic analysis is still missing. We hereby provide such an analysis, by deriving the relevant framework from first principles. We start from a complete microscopic description of the qubit-bath system where definitions of heat, work and entropy production are unambiguous. We trace out the bath and coarse-grain the resulting expressions in time, using a methodology similar to the derivation of the dynamical master equation, to derive closed expressions for the First and Second Law in terms of system properties. Long coarse graining times yield the Floquet Master Equation and its already known thermodynamic description. Short coarse-graining times yield instead to the OBE and a novel thermodynamic framework which explicitly depend on quantum coherences in the qubit’s energy basis which produce quantum signatures in the heat and entropy production flows. This allow us to characterize a genuinely quantum non-equilibrium situation, where the coherences created by the driving field are continuously erased by the bath. Our findings can be readily extended to larger open quantum systems. They carry the seeds for future thermodynamic analyses of quantum gates and the design of quantum engines in the strong coherent driving regime. Copyright © 2020, The Authors. All rights reserved.

关键词： Entropy

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VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up

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Annals of Oncology 2022年第9期33卷 986-987页

作者： S. Loibl J. Jassem A. Sonnenblick D. Parlier E. Winer J. Bergh R.D. Gelber E. Restuccia Y-H. Im C. Huang F. Dalenc I. Calvo M. Procter C. Caballero E. Clark H.L. Gomez Moreno J. Bliss G. Viale J. Bines M. Piccart Medicine and Research Dept. German Breast Group (GBG) Forschungs GmbH Neu-Isenburg Germany Oncology & Radiotherapy Medical University of Gdansk Gdansk Poland Oncology Department Tel Aviv Sourasky Medical Center-(Ichilov) Tel Aviv Israel Clinical Trials Support Unit Institut Jules Bordet Brussels Belgium Yale Cancer Center Yale University School of Medicine - Yale Cancer Center New Haven CT USA Department of Oncology-Pathology Karolinska Institutet and Breast Cancer Centre Cancer Theme Karolinska University Hospital Stockholm Sweden Biostatistics Dana Farber Cancer Institute Boston MA USA Product Development Oncology F. Hoffmann-La Roche Ltd Basel Switzerland Medicine Dept. Hematology/Medical Oncology Division Samsung Medical Center (SMC) - Sungkyunkwan University School of Medicine Seoul Republic of Korea Surgery Dept. NTUH - National Taiwan University Hospital Taipei Taiwan Oncologie 1A Institut Universitaire du Cancer Toulouse - Oncopole Toulouse France Breast Cancer Unit MD Anderson Cancer Center Madrid Madrid Spain Statistics and Programming Frontier Science Scotland Kincraig UK Medical Department Breast International Group (BIG) - AISBL Brussels Belgium Data Sciences - Data & Statistical Sciences (DSS) Roche Products Limited Welwyn Garden City UK Medicine Department INEN - Instituto Nacional de Enfermedades Neoplasicas Lima Peru Clinical Trials and Statistics Unit ICR - Institute of Cancer Research London UK Department of Oncology Università degli Studi di Milano Milan Italy Medical Oncology Department Instituto Nacional de Cancer - Research Center Rio de Janeiro Brazil Institut Jules Bordet Brussels Belgium

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