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Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

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Journal of pharmaceutical Analysis 2024年第6期14卷 785-804页

作者： Patanachai K.Limpikirati Sorrayut Mongkoltipparat Thinnaphat Denchaipradit Nathathai Siwasophonpong Wudthipong Pornnopparat Parawan Ramanandana Phumrapee Pianpaktr Songsak Tongchusak Maoxin Tim Tian Trairak Pisitkun Department of Food and pharmaceutical Chemistry Faculty of Pharmaceutical SciencesChulalongkorn UniversityPathumwanBangkok10330Thailand pharmaceutical sciences and Technology(PST)Graduate program Faculty of Pharmaceutical SciencesChulalongkorn UniversityPathumwanBangkok10330Thailand Center of Excellence in Systems Biology(CUSB) Faculty of MedicineChulalongkorn UniversityPathumwanBangkok10330Thailand Department of pharmaceutical Chemistry Faculty of Pharmaceutical SciencesHuachiew Chalermprakiet UniversityBang PhliSamut Prakan10540Thailand Division of Research Affairs Faculty of MedicineChulalongkorn UniversityPathumwanBangkok10330Thailand

In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and *** specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered *** of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance *** attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the *** criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric *** in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial *** are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.

关键词： Biopharmaceutical analysis Biopharmaceutical quality control Biopharmaceutical specifications Monoclonal antibodies Protein therapeutics Regulatory science

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Oral delivery of ferroptosis inducers for effective treatment of hepatic fibrosis

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Nano Research 2024年第8期17卷 7621-7630页

作者： Yinglan Yu Shunlong Zhang Yongfeng Xu Hao Shao Lei Luo College of pharmaceutical sciences Southwest UniversityChongqing 400715China

Liver fibrosis is characterized by the excessive accumulation of extracellular matrix(ECM),which is primarily produced by activated hepatic stellate cells(HSCs).However,effective therapies for hepatic fibrosis are currently *** is a promising anti-fibrotic drug candidate,but its clinical application is hindered by limited ***,we present a novel oral delivery platform that enhances the HSCs uptake of artesunate and induces potent *** platform is vitamin Adecorated nanoparticles encapsulated with *** multifunctional ligand vitamin A interacts with retinol-binding proteins that are highly expressed on the intestinal epithelium to promote transcytosis,highly expressed on the surface of HSCs but lowly expressed in normal *** oral administration,this oral delivery platform enhances transepithelial transport in the intestine,improves drug accumulation in the liver,and continuously increases HSCs uptake of *** drug release in HSCs,artesunate depletes glutathione peroxidase 4 and glutathione,effectively initiating *** vivo experiments demonstrate that this strategy induces pronounced ferroptosis,efficiently relieving liver *** work provides a proof-ofconcept demonstration that an oral delivery strategy for ferroptosis inducers may be beneficial for liver fibrosis treatment.

关键词： liver fibrosis hepatic stellate cells oral delivery intestinal epithelium ferroptosis

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Caffeic acid 3,4-dihydroxyphenethyl ester prevents colorectal cancer through inhibition of multiple cancer-promoting signal pathways in 1,2-Dimethylhydrazine/dextran sodium sulphate mouse model

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Journal of Traditional Chinese Medicine 2024年第1期44卷 70-77页

作者： JIN Tao ZHOU Qian SHEN Jichen ZHANG Zhizhong LIAN Xiaoyuan College of pharmaceutical sciences Zhejiang UniversityHangzhou 310058China pharmaceutical Informatics Institute College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058China Ocean College Zhoushan Campus of Zhejiang UniversityZhoushan 316021China

OBJECTIVE:To elucidate the potential feature and mechanism of the caffeic acid 3,4-dihydroxyphenethyl ester(CADPE)molecule,which can prevent colorectal cancer(CRC)in the 1,2-Dimethylhydrazine(DMH)/dextran sodium sulphate(DSS)-induced mouse ***:Institute of cancer research(ICR)male mice were injected with 20 mg/kg DMH for a *** that,2%DSS was administered in the drinking water for another 7 *** CADPE treatment was given to the DMH/DSS induced male mice at three different periods until their *** examination was used for observing the CRC development at colonic ***(IHC),blood cells smearing and crypt damage scoring methods were used for investigating the anti-inflammation feature of CADPE related to *** reversing targets searching method was applied with artificial intelligence(AI),computeraided drug designing(CADD)and Ingenuity Pathway Analysis(IPA)techniques for predicting the potential targets and mechanism of CADPE highly related to ***:The data indicated that CADPE inhibited CRC tumor development in the colitis-associated DMH/DSS induced mouse model after giving the early *** also impeded the acute inflammation by decreasing the infiltration of neutrophils significantly during the initial stage of CRC ***,our data showed that CADPE prevented CRC by blocking active sites of three pivotal protein targets including epidermal growth factor receptor(EGFR),extracellular signal-regulated kinase(ERK)and mammalian target of rapamycin(m TOR)in two major cancer development ***:CADPE effectively prevented CRC at early stage of tumor germination in the DMH/DSS mouse model highly likely due to its anti-acute inflammation characteristic and the ability of blocking EGFR,ERK and m TOR activities in two highly related CRC developing pathways.

关键词： caffeic acids colorectal neoplasms inflammation chemoprevention Sarcandra glabra

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A comprehensive review on pharmacognosy, phytochemistry and pharmacological activities of 8 potent Prunus species of southeast Asia

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Journal of Traditional Chinese Medicine 2024年第3期44卷 620-628页

作者： Shikha Agrawal Adarsh Kumar Ankit Kumar Singh Harshwardhan Singh Suresh Thareja Pradeep Kumar Department of pharmaceutical sciences and Natural Products Central University of Punjab

Genus Prunus comprising around 430 species is a vast important genus of family Rosaceae, subfamily amygdalaoidae. Among all 430 species, around 19 important species are commonly found in Indian subcontinent due to their broad nutritional and economic importance. Some most common species of genus Prunus are Prunus amygdalus, Prunus persica, Prunus armeniaca, Prunus avium, Prunus cerasus, Prunus cerasoides, Prunus domestica, Prunus mahaleb, etc. A newly introduced species of Prunus i.e Prunus sunhangii is recently discovered which is morphologically very similar to Prunus cerasoides. Plants of Prunus species are short to medium-sized deciduous trees mainly found in the northern hemisphere. In India and its subcontinent,it extends from the Himalayas to Sikkim, Meghalaya,Bhutan, Myanmar etc. Different Prunus species have been extensively studied for their morphological,microscopic, pharmacological and phytoconstituents characteristics. Total phenolic content of Prunus species explains the presence of phenols in high quantity and pharmacological activity due to phenols. Phytochemical screening of species of genus Prunus shows the presence of wide phytoconstituents which contributes in their pharmacological significance and reveals the therapeutic potential and traditional medicinal significance of this genus. Genus Prunus showed a potent antioxidant activity analyzed by 1,1-diphenyl-2-picryl-hydrazyl radical assay. Plant species belonging to the genus Prunus is widely used traditionally for the treatment of various disorders. Some specific Prunus species possess potent anticancer, anti-inflammatory,hypoglycemic etc. activity which makes the genus more interesting for further research and findings. This review is an attempt to summarize the comprehensive study of Prunus species from its distribution, morphological characters to phytoconstituents, and pharmacological activity.

关键词： Prunus Rosaceae antineoplastic agents distribution hypoglycemic agents phytochemistry review

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Pharmacological potential of Manilkara zapota(L.)***(Sapodilla):a narrative review

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Journal of Traditional Chinese Medicine 2024年第2期44卷 403-407页

作者： Priyanka Sharma Aakash Deep Harish Kumar Nitin Bansal Sanjiv Kumar Arun Davinder Kumar Department of pharmaceutical sciences Chaudhary Bansi Lal UniversityBhiwani 127021India Department of pharmaceutical sciences Maharishi Dayanand UniversityRohtak 124001India

Herbal medicine is safe and effective in treating various *** herbal medicine plays a tremendous role in treatment of various diseases and accompanying complications,hence herbal medicine requires remarkable attention in further research for the development of numerous active formulations for treatment of health *** plant needs special consideration for development and research of unidentified compound and characterization of novel active molecules that overcome multiple pathological *** genus Manilkara contains 135 plants around the *** overview discusses all the virtues of most important and commonly used plant Manilkara zapota(L.)***(***),also known as *** has various traditional beneficial effects in treatment of various diseases and disorders dating back to prehistoric times and used in ancient traditional system of herbal medicine.

关键词： herbal medicine Manilkara zapota phytoconstituents pharmacological activity review

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Real-time model correction using Kalman filter for Raman-controlled cell culture processes

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Chinese Journal of Chemical Engineering 2024年第6期70卷 251-260页

作者： Xiaoxiao Dong Zhuohong He Xu Yan Dong Gao Jingyu Jiao Yan Sun Haibin Wang Haibin Qu pharmaceutical Informatics Institute College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058China Hisun Biopharmaceutical Co.Ltd. Hangzhou 311404China

Raman spectroscopy has found extensive use in monitoring and controlling cell culture *** this context,the prediction accuracy of Raman-based models is of paramount ***,models established with data from manually fed-batch cultures often exhibit poor performance in Raman-controlled ***,there is a need for effective methods to rectify these *** objective of this paper is to investigate the efficacy of Kalman filter(KF)algorithm in correcting Raman-based models during cell ***,partial least squares(PLS)models for different components were constructed using data from manually fed-batch cultures,and the predictive performance of these models was ***,various correction methods including the PLS-KF-KF method proposed in this study were employed to refine the PLS ***,a case study involving the auto-control of glucose concentration demonstrated the application of optimal model correction *** results indicated that the original PLS models exhibited differential performance between manually fed-batch cultures and Raman-controlled *** glucose,the root mean square error of prediction(RMSEP)of manually fed-batch culture and Raman-controlled culture was 0.23 and 0.40 g·L^(-1).With the implementation of model correction methods,there was a significant improvement in model performance within Raman-controlled *** RMSEP for glucose from updating-PLS,KF-PLS,and PLS-KF-KF was 0.38,0.36 and 0.17 g·L^(-1),***,the proposed PLS-KF-KF model correction method was found to be more effective and stable,playing a vital role in the automated nutrient feeding of cell cultures.

关键词： Raman spectroscopy Model correction Algorithm Model-predictive control Bioprocess

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The Contributions of Thrombospondin-1 to Epilepsy Formation

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Neuroscience Bulletin 2024年第5期40卷 658-672页

作者： Yao Cheng Yujie Zhai Yi Yuan Qiaoyun Wang Shucui Li Hongliu Sun School of pharmaceutical sciences Binzhou Medical UniversityYantai264003China

Epilepsy is a neural network disorder caused by uncontrolled neuronal hyperexcitability induced by an imbalance between excitatory and inhibitory *** synaptogenesis plays a vital role in the formation of overexcited *** evidence has confirmed that thrombospondin-1(TSP-1),mainly secreted by astrocytes,is a critical cytokine that regulates synaptogenesis during ***,numerous studies have reported that TSP-1 is also involved in other processes,such as angiogenesis,neuroinflammation,and regulation of Ca^(2+)homeostasis,which are closely associated with the occurrence and development of *** this review,we summarize the potential contributions of TSP-1 to epilepsy development.

关键词： Thrombospondin-1 Epileptogenesis Synaptogenesis Hyperexcitability

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A One Health approach to fight antimicrobial resistance in Uganda: Implementation experience, results, and lessons learned

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Biosafety and Health 2024年第2期6卷 125-132页

作者： Reuben Kiggundu J.P.Waswa Niranjan Konduri Hassan Kasuja Marion Murungi Patrick Vudriko Harriet Akello Eric Lugada Cecilia Muiva Esther Were Dinah Tjipura Henry Kajumbula Kate Kikule Emmanuel Nfor Mohan P.Joshi USAID Medicines Technologiesand Pharmaceutical Services ProgramManagement Sciences for HealthKampala 256Uganda USAID Medicines Technologiesand Pharmaceutical Services ProgramManagement Sciences for HealthArlingtonVA 22203USA College of Veterinary Medicine Animal Resources and BiosecurityMakerere UniversityKampala 256Uganda Ministry of Health Uganda Kampala 256Uganda USAID Strengthening Supply Chain Systems Activity Management Sciences for HealthKampala 256Uganda USAID Medicines Technologiesand Pharmaceutical Services ProgramManagement Sciences for HealthNairobi 254Kenya Department of Microbiology College of Health SciencesMakerere UniversityKampala 256Uganda

Uganda has been implementing the Global Health Security Agenda(GHSA)since 2015 to build its capacity according to World Health Organization(WHO)Benchmarks on International Health Regulations *** country remains prone to outbreaks,with more than 20 disease outbreaks reported in the past five years,including Ebola virus disease,Crimean-Congo haemorrhagic fever,Marburg haemorrhagic fever,measles,yellow fever,coronavirus disease 2019(COVID-19),and *** resistance(AMR)is an ongoing *** scored capacity level 3 on infection prevention and control(IPC)and antimicrobial stewardship(AMS)in the 2017 Joint External Evaluation(JEE)*** gaps were being addressed after a self-assessment in *** paper describes the technical assistance approaches provided to Uganda by the Medicines,Technologies,and pharmaceutical Services program,funded by the United States(U.S.)Agency for International Development,and implemented by Management sciences for *** program,through a One Health approach,supported systematic capacity strengthening based on the JEE's capacity advancement framework for global health security,specifically relating to *** program's interventions impacted 32 WHO benchmark actions(7 for AMR multisectoral coordination,16 for IPC,and 9 for AMS),contributing to Uganda's strengthened GHSA *** success built on the AMR platform,the program trained 745 health workers in IPC for the Ebola virus and provided support for simulation exercises by eight district IPC *** program also worked with the Ministry of Health to coordinate IPC for the COVID-19 response in five health regions,covering 45 districts and reaching 5,452 health workers at 858 health facilities.

关键词： One health Antimicrobial resistance Antibiotic resistance Jointexternal evaluation Global health security Uganda Africa WHO Benchmarks for International Health Regulations Capacities

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Complications and comorbidities associated with antineoplastic chemotherapy:Rethinking drug design and delivery for anticancer therapy

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Acta Pharmaceutica Sinica B 2024年第7期14卷 2901-2926页

作者： Xiaoman Mao Shuang Wu Dandan Huang Chong Li College of pharmaceutical sciences Southwest UniversityChongqing 400715China Medical Research Institute Southwest UniversityChongqing 400715China School of pharmaceutical sciences Southern Medical UniversityGuangzhou 510515China

Despite the considerable advancements in chemotherapy as a cornerstone modality in cancer treatment,the prevalence of complications and pre-existing diseases is on the rise among cancer patients along with prolonged survival and aging *** relationships between these disorders and cancer are intricate,bearing significant influence on the survival and quality of life of individuals with cancer and presenting challenges for the prognosis and outcomes of ***,we review the prevailing complications and comorbidities that often accompany chemotherapy and summarize the lessons to learn from inadequate research and management of this scenario,with an emphasis on possible strategies for reducing potential complications and alleviating comorbidities,as well as an overview of current preclinical cancer models and practical advice for establishing bio-faithful preclinical models in such complex context.

关键词： Complications Comorbidities Chemotherapy Preclinical cancer models Drug design Drug delivery

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Immune checkpoint inhibitors:breakthroughs in cancer treatment

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Cancer Biology & Medicine 2024年第6期21卷 451-472页

作者： Xueqing Kong Jinyi Zhang Shuwei Chen Xianyang Wang Qing Xi Han Shen Rongxin Zhang Laboratory of Immunology and Inflammation School of Life Sciences and BiopharmaceuticsGuangdong Pharmaceutical UniversityGuangzhou 510006China Department of Biology School of Life Sciences and BiopharmaceuticsGuangdong Pharmaceutical UniversityGuangzhou 510006China

Over the past two decades,immunotherapies have increasingly been considered as first-line treatments for most *** such treatment is immune checkpoint blockade(ICB),which has demonstrated promising results against various solid tumors in clinical *** antibodies(mAbs)are currently available as immune checkpoint inhibitors(ICIs).These ICIs target specific immune checkpoints,including cytotoxic T-lymphocyte-associated antigen-4(CTLA-4)and programmed cell death protein 1(PD-1).Clinical trial results strongly support the feasibility of this immunotherapeutic ***,a substantial proportion of patients with cancer develop resistance or tolerance to treatment,owing to tumor immune evasion mechanisms that counteract the host immune ***,substantial research focus has been aimed at identifying additional ICIs or synergistic inhibitory receptors to enhance the effectiveness of anti-PD-1,anti-programmed cell death ligand 1(anti-PD-L1),and anti-CTLA-4 ***,several immune checkpoint molecular targets have been identified,such as T cell immunoreceptor with Ig and ITIM domains(TIGIT),mucin domain containing-3(TIM-3),lymphocyte activation gene-3(LAG-3),V-domain immunoglobulin suppressor of T cell activation(VISTA),B and T lymphocyte attenuator(BTLA),and signal-regulatory proteinα(SIRPα).Functional m Abs targeting these molecules are under ***-4,PD-1/PD-L1,and other recently discovered immune checkpoint proteins with distinct structures are at the forefront of *** review discusses these structures,as well as clinical progress in m Abs targeting these immune checkpoint molecules and their potential applications.

关键词： Immunotherapy cancer ICIs PD-1 CTLA-4

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