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Structure-based design,synthesis of novel inhibitors of Mycobacterium tuberculosis FabH as potential anti-tuberculosis agents

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Chinese Chemical Letters 2009年第9期20卷 1019-1022页

作者： Xue Hui Zhang Hong Yu Wu Zhong Li LiWang Song Li Beijing Institute of Pharmacology and Toxicology Beijing 100850 China drug Evaluation Center of State food and drug administration Beijing 100038 China

Mycobacterium tuberculosis FabH, an essential enzyme in mycolic acids biosynthetic pathway, is an attractive target for novel anti-tuberculosis agents. Structure-based design, synthesis of novel inhibitors of mtFabH was reported in this paper. A novel scaffold structure was designed, and 12 candidate compounds that displayed favorable binding with the active site were identified and synthesized. 2009 Song Li. Published by Elsevier B.V. on behalf of Chinese Chemical Society. All rights reserved.

关键词： Structure-based design Synthesis Enzyme inhibitor Mycobacterium tuberculosis FabH

Discrimination of polysorbate 20 by high-performance liquid chromatography-charged aerosol detection and characterization for components by expanding compound database and library

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Journal of Pharmaceutical Analysis 2024年第5期14卷 722-732页

作者： Shi-Qi Wang Xun Zhao Li-Jun Zhang Yue-Mei Zhao Lei Chen Jin-Lin Zhang Bao-Cheng Wang Sheng Tang Tom Yuan Yaozuo Yuan Mei Zhang Hian Kee Lee Hai-Wei Shi Jiangsu Institute for food and drug Control Nanjing210019China School of Pharmacy China Pharmaceutical UniversityNanjing211112China School of Pharmacy Nanjing University of Chinese MedicineNanjing210046China Chinese Pharmacopoeia Commission Beijing100061China Nanjing Well Pharmaceutical Group Co. Ltd.Nanjing210018China School of Environmental and Chemical Engineering Jiangsu University of Science and TechnologyZhenjiangJiangsu212003China University of Massachusetts Amherst Amherst01003USA Department of Chemistry National University of SingaporeSingapore117543Singapore

Analyzing polysorbate 20(PS20)composition and the impact of each component on stability and safety is crucial due to formulation variations and individual *** similar structures and polarities of PS20 components make accurate separation,identification,and quantification *** this work,a high-resolution quantitative method was developed using single-dimensional high-performance liquid chromatography(HPLC)with charged aerosol detection(CAD)to separate 18 key components with multiple *** separated components were characterized by ultra-high-performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UHPLC-Q-TOF-MS)with an identical gradient as the HPLC-CAD *** polysorbate compound database and library were expanded over 7-time compared to the commercial *** method investigated differences in PS20 samples from various origins and grades for different dosage forms to evaluate the composition-process ***-Q-TOF-MS identified 1329 to 1511 compounds in 4 batches of PS20 from different *** method observed the impact of 4 degradation conditions on peak components,identifying stable components and their tendencies to ***-CAD and UHPLC-Q-TOF-MS results provided insights into fingerprint differences,distinguishing quasi products.

关键词： Polysorbate 20 Component Database Discrimination Degradation

Critical role of bioinformatics in translating huge amounts of next-generation sequencing data into personalized medicine

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Science China(Life Sciences) 2013年第2期56卷 110-118页

作者： HONG HuiXiao ZHANG WenQian SHEN Jie SU ZhenQiang NING BaiTang HAN Tao PERKINS Roger SHI LeMing TONG WeiDa Division of Bioinformatics and Biostatistics National Center for Toxicological ResearchUS Food and Drug Administration Beijing Genomic Institute Beishan Industrial Zone Division of Systems Biology National Center for Toxicological ResearchUS Food and Drug Administration

Realizing personalized medicine requires integrating diverse data types with *** most vital data are genomic information for individuals that are from advanced next-generation sequencing(NGS) technologies at *** technologies continue to advance in terms of both decreasing cost and sequencing speed with concomitant increase in the amount and complexity of the *** prodigious data together with the requisite computational pipelines for data analysis and interpretation are stressors to IT infrastructure and the scientists conducting the work *** is increasingly becoming the rate-limiting step with numerous challenges to be overcome for translating NGS data for personalized *** review some key bioinformatics tasks,issues,and challenges in contexts of IT requirements,data quality,analysis tools and pipelines,and validation of biomarkers.

关键词： personalized medicine next-generation sequencing bioinformatics short reads alignment assemble data analysis

Weizmannia coagulans:an ideal probiotic for gut health

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food Science and Human Wellness 2024年第1期13卷 16-26页

作者： Shiqi Zhang Pinglan Li Suwon Lee Yu Wang Chunming Tan Nan Shang Key Laboratory of Functional Dairy Ministry of EducationCollege of Food Science and Nutritional EngineeringChina Agricultural UniversityBeijing 100083China Coree Beijing Co. Ltd.Beijing 101312China Key Laboratory of Precision Nutrition and food Quality Department of Nutrition and HealthChina Agricultural UniversityBeijing 100083China College of Engineering China Agricultural UniversityBeijing 100083China

Weizmannia coagulans(formerly Bacillus coagulans)is a spore-forming and lactic acid-producing *** has recently attracted much attention from researchers and food manufacturers due to its probiotic functions and stability in processing and *** is capable of improving gut health through the regulation of gut microbiota,modulation of immunity,and improving digestibility and ***,germinated cells and metabolites of *** modulate the gut micro-environment and further affect other *** is an environment-friendly probiotic since it can contribute to the host by reconstructing the balance of gut microbiota and only temporarily resides in the intestine after *** has been generally recognized as safe(GRAS)by the US food and drug administration(FDA),thus it is an ideal probiotic for improving gut *** merit of its stability in processing and storage provides *** spores many possibilities for its use in various types of functional *** review presents an overview of the characteristics of *** that make it an ideal probiotic candidate and highlights the proposed health benefits with scientific evidence conferred by the administration of ***.

关键词： Weizmannia coagulans Spore former Probiotics Microbiota Gut disorders

Review on drug Regulatory Science Promoting COVID-19 Vaccine Development in China

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Engineering 2022年第3期8卷 127-132页

作者： Zhiming Huang Zhihao Fu Junzhi Wang National Medical Products administration Beijing 100053China National Institutes for food and drug Control Beijing 102629China

Regulatory science is a discipline that uses comprehensive methods of natural science,social science,and humanities to provide support for administrative decision-making through the development of new tools,standards,and approaches to assess the safety,efficacy,quality,and performance of regulated *** the pandemics induced by infectious diseases,such as H1N1 flu,severe acute respiratory syndrome(SARS),and Middle East respiratory syndrome(MERS),regulatory science strongly supported the development of drugs and vaccines to respond to the *** particular,with the support of research on drug regulatory science,vaccines have played a major role in the prevention and control of coronavirus disease 2019(COVID-19).This review summarizes the overall state of the vaccine industry,research and development(R&D)of COVID-19 vaccines in China,and the general state of regulatory science and supervision for vaccines in ***,this review highlights how regulatory science has promoted the R&D of Chinese COVID-19 vaccines,with analyses from the aspects of nationallevel planning,relevant laws and regulations,technical guidelines,quality control platforms,and postmarketing ***,this review provides a reference for the formulation of a vaccine development strategy in response to the current pandemic and the field of vaccine development in the post-pandemic era,as well as guidance on how to better respond to emerging and recurring infectious diseases that may occur in the future.

关键词： Regulatory science COVID-19 vaccine Vaccine industry

Innovative confocal laser method for exact dioptric power measurement of intraocular lens implants Invited Paper

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Chinese Optics Letters 2008年第12期6卷 876-878页

作者： Ilko K.Ilev Robert W.Faaland Do-Hyun Kim Robert H.James Don Calogero Office of Science and Engineering Laboratories Center for Devices and Radiological Health U.S.Food and Drug Administration10903 New Hampshire AvenueSilver Spring Office of Device Evaluation Center for Devices and Radiological Health U.S.Food and Drug Administration9200 Corporate BoulevardRockville

We present a novel confocal laser method （CLM） for precise testing of the dioptric power of both positive and negative intraocular lens （IOL） implants. The CLM principle is based on a simple fiber-optic confocal laser design including a single-mode fiber coupler that serves simultaneously as a point light source used for formation of a collimated Gaussian laser beam, and as a highly sensitive confocal point receiver. The CLM approach provides an accurate, repeatable, objective, and fast method for IOL dioptric power measurement over the range from 0 D to greater than ±30 D under both dry and in-situ simulated conditions.

关键词： Crystalline lens Fiber optic couplers Gaussian beams Intraocular lenses Laser beams Single mode fibers

Clinical review considerations of class I PI3K inhibitors in hematolymphatic malignancies by Center for drug Evaluation

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Chinese Journal of Cancer Research 2022年第4期34卷 415-421页

作者： Limin Zou Yueli Qi Ling Tang Yu Du Meiyi Xiang Xiaoming Chen Jun Ma Zhimin Yang Office of Clinical Evaluation 1 Center for Drug EvaluationNational Medical Products AdministrationBeijing 100022China Office of Management and Communication Center for Drug EvaluationNational Medical Products AdministrationBeijing 100022China harbin Institute of Hematology and Oncology Harbin 150010China

Several phosphoinositide 3-kinase(PI3 K) inhibitors are currently approved to treat hematolymphatic malignant diseases worldwide, and many drugs that have the same target are in the clinical research stage. In March 2022,duvelisib became the first PI3 K inhibitor approved in China indicated for the treatment of hematolymphatic malignant diseases. Meanwhile, linperlisib and copanlisib have almost completed the technical review of the clinical specialty. The Center for drug Evaluation(CDE) of the China National Medical Products administration(NMPA) found that class I PI3 K inhibitors can cause various degrees of immune-related adverse events, which are associated with action mechanisms, affecting the benefit-risk assessment of the drugs. On April 21, 2021, the United States food and drug administration(FDA) convened the Oncologic drugs Advisory Committee(ODAC)meeting to discuss the safety of PI3 K inhibitors indicated for hematolymphatic malignancies and their related risk of death. The hematological tumor group of CDE of the China NMPA summarized and combined the data on PI3 K inhibitors listed or under technical review for marketing authorization applications and found that such products may have unique efficacy and safety characteristics in Chinese patients with malignant lymphoma.

关键词： Class I PI3K inhibitors efficacy hematolymphatic malignancies safety

Biomarkers of Aging: Changes in Circadian Rhythms Related to the Modulation of Metabolic Output

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Biomedical and Environmental Sciences 1991年第1期4卷 182-191页

作者： PETER H.DUFFY RITCHIE J.FEUERS food and drug administration Natiomd Center Jbr Toxicological Research JeffersonFood and Drug Administration Natiomd Center Jbr Toxicological Research Jefferson Arkansas 72079 To whom correspondence should be addressedArkansas 72079

Twenty-four hour (circadian) rhythmicity is an important component of biological variability associated with studies relating to biomarkers of aging. Chronobiological testing techniques must be utilized because (1) many variables that are related to the modulation of metabolic output vary dramatically at different times of the day; (2) various experimental variable and treatment groups must be synchronized with environmental cues that control circadian rhythms; and (3) multiple circadian variables may interact together to modulate the rate of aging. The rhythm for physiological factors such as whole animal metabolic output, body temperature, heart rate, urine flow, potassium, etc. were found to be dissociated or altered by the senescence process; behavioral variables such as spontaneous activity, wheel running, feeding and drinking, verbal performance, as well as sleep-wakefulness rhythms, seem to be accurate predictors of biological age. Circadian rhythms for a variety of enzymes of intermediary metabolism which are directly associated with energy metabolism have been well documented. These well-defined rhythms of enzyme activity have also been shown to degenerate with aging. Rhythms tend to lose amplitude as activity falls with age and as a general loss of regulation (especially time of day where maximal activity might be found) of activity across the 24-h span occurs. As with behavioral variables, changes in enzyme rhythms appear to accurately predict aging. Generally speaking, the loss of temporal organization with age, characterized by decreased circadian amplitude, loose internal synchronization, and poor response to external environmental time queues, is associated with poor health states and decreased longevity. Temporal rhythms for whole animal parameters are highly correlated with molecular events, such as regulation of cellular metabolism. DNA repair, and gene expression. Automated data acquisition and process control systems will be required for future C

关键词： Biomarkers of Aging Changes in Circadian Rhythms Related to the Modulation of Metabolic Output

Two new C-glucoside oxanthrones from Rumex gmelini

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Chinese Chemical Letters 2009年第7期20卷 839-841页

作者： Zhen Yue Wang Hai Peng Zhao Yue Ming Zuo Zong Quan Wang Xian Ming Tang Graduate School of Heilongjiang University of Traditional Chinese Medicine Harbin 150040 China Lunan Pharmaceutical Group Corporation Linyi 276005 China Jiangxi University of Traditional Chinese Medicine Nanchang 330004 China Yiling Pharmaceutical Group Corporation Shijiazhuang 050035 China harbin food and drug administration Harbin 150016 China

Two new C-glucoside oxanthrones, 6-methoxyl-10-hydroxyaloin A （1） and 6-methoxyl-10-hydroxyaloin B （2）, were isolated from the roots of Rumex gmelini Turcz. Their structures were elucidated on the basis of spectroscopic techniques and chemical means C 2009 Zhen Yue Wang. Published by Elsevier B.V. on behalf of Chinese Chemical Society. All fights reserved.

关键词： Rumex gmelini Turcz. C-glucosidc oxanthrones 6-Methoxyl-10-hydroxyaloin A 6-Methoxyl-10-hydroxyaloin B