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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

Changes in Metabolites and Allelopathic Effects of Non-Pigmented and Black-Pigmented Lowland Indica Rice Varieties in Phosphorus Deficiency

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Rice science 2024年第4期31卷 434-448,I0025,I0026页

作者： Liyana SARA Sompop SAEHENG Panupong PUTTARAK Lompong KLINNAWEE Division of Biological science Faculty of SciencePrince of Songkla UniversitySongkhla 90110Thailand Division of Health and Applied sciences Faculty of SciencePrince of Songkla UniversitySongkhla 90110Thailand Plant Cell and Physiology for Sustainable Agriculture Research Unit Faculty of SciencePrince of Songkla UniversitySongkhla 90110Thailand Department of Pharmacognosy and pharmaceutical Botany Faculty of Pharmaceutical SciencesPrince of Songkla UniversitySongkhla 90110Thailand Phytomedicine and pharmaceutical Biotechnology Excellence Center Prince of Songkla UniversitySongkhla 90110Thailand

Phosphorus(P) levels alter the allelopathic activity of rice seedlings against lettuce seeds. In this study, we investigated the effect of P deficiency on the allelopathic potential of non-pigmented and pigmented rice varieties. Rice seedlings of the white variety Khao Dawk Mali(KDML105, non-pigmented) and the black varieties Jao Hom Nin(JHN, pigmented) and Riceberry(RB, pigmented) were cultivated under high P(HP) and low P(LP) conditions. Morphological and metabolic responses to P deficiency were investigated. P deficiency inhibited shoot growth but promoted root growth of rice seedlings in all three varieties. Moreover, P deficiency led to decreased cytosolic phosphate(Pi) and total P concentrations in both shoot and root tissues. The subsequent reduction in internal P concentration enhanced the accumulation of phenolic compounds in both shoot and root tissues of the seedlings. Subsequently, allelopathy-based inter-and intra-specific interactions were assessed using water extracts from seedlings of the three varieties grown under HP and LP conditions. These extracts were tested on seeds of lettuce, the weed Dactyloctenium aegyptium, and the same rice variety. The shoot and root extracts from P-deficient seedlings reduced the germination of all recipient plants. Specifically, the shoot extract from P-deficient KDML105 seedlings reduced the germination index(GI) of lettuce seeds to 1%, while those from P-deficient RB and JHN seedlings produced GIs of 32% and 42%, respectively. However, when rice seeds were exposed to their own LP shoot and root extracts, their GIs increased up to 4-fold, compared with the HP extracts. Additionally, the shoot extracts from P-deficient plants also stimulated the germination of D. aegyptium by about 2–3-fold, whereas the root extracts did not have this effect. Therefore, P starvation led to the accumulation and exudation of phenolics in the shoots and roots of rice seedlings, altering their allelopathic activities. To adapt to P defici

关键词： phosphorus deficiency non-pigmented and black-pigmented rice phenolics extract allelopathy

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Comprehensive review on ethnomedicinal, phytochemistry and pharmacological profile of Ficus Religiosa L.

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Journal of Traditional Chinese medicine 2024年第5期44卷 1052-1057页

作者： Rahul Rawat Harish Kumar Neetu Singh Aakash Deep Balasubramanian Narasimhan Surender Singh Yadav Sanjiv Kumar Department of pharmaceutical sciences Chaudhary Bansi Lal University Department of Botany Maharshi Dayanand University faculty of pharmaceutical sciences Maharshi Dayanand University

Ficus religiosa L.(F. religiosa) or sacred fig is a large perennial tree belonging to the family Moraceae or mulberry family. Though the tree has pan-tropical distribution but originally it is indigenous to the Indian subcontinent and Indochina region. Popularly the tree is named "Pepal or bodhi tree". Traditionally, it is practiced for the treatment of asthma, nose bleeding, heart disorders, diabetes, wound healing, ear problems, constipation, hyperlipidemia, gonorrhea, ulcers and infectious disorders. Chemical analysis demonstrated the presence of numerous bioactives including tannins, phenols, saponins, sugars, alkaloids, methionine, terpenoids, flavonoids, glycosides, proteins, separated amino acids, essential and volatile oils and steroids etc., which are probably responsible for its diverse pharmacological actions. The present work is an attempt to compile up-to-date comprehensive information on F. religiosa that covers its taxonomy, ethnomedicinal importance, phytochemistry, pharmacological attributes and clinical trials. Keeping in mind the various health attributes of F. religiosa, future research can be aimed at in-depth elucidation of the structure-function relationship and multifactorial signalings pathways.

关键词： Ficus religiosa clinical trials ethnomedicine health benefits pharmacology phytoconstituents

Amide naphthotubes:Biomimetic macrocycles for selective molecular recognition

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Chinese Chemical Letters 2024年第4期35卷 124-131页

作者： Cheng-Da Zhao Huan Yao Shi-Yao Li Fangfang Du Li-Li Wang Liu-Pan Yang School of pharmaceutical science Postdoctoral Research Station of Basic MedicineHengyang Medical SchoolUniversity of South ChinaHengyang 421001China

Selective molecular recognition in water is routine for bioreceptors,but remains challenging for synthetic *** is principally because noncovalent interactions are usually less efficient in aqueous *** mimicking the cavity feature of bioreceptors,*** Jiang proposed and clarified the concept of“endo-functionalized cavity”.Through situating polar binding sites into a deep hydrophobic cavity,we designed and synthesized several macrocyclic hosts,among which amide naphthotubes are the most *** hosts can selectively recognize various polar molecules including organic micropollutants,drug molecules,and chiral molecules in water by employing the hydrophobic effect and shielded hydrogen *** addition,these biomimetic hosts have been applied in spectroscopic analysis,adsorptive separation and *** this review,we provide an overview of recent advances on amide naphthotubes with special emphasis on the efforts of Jiang's *** are convinced that these biomimetic macrocycles will make further contributions to supramolecular chemistry and beyond.

关键词： Molecular recognition Supramolecular chemistry Amide naphthotube Endo-functionalized cavity Biomimetic macrocycle

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Frontiers and future perspectives of neuroimmunology

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Fundamental Research 2024年第2期4卷 206-217页

作者： Hai Qi Shumin Duan Yanying Xu Hongliang Zhang School of medicine Tsinghua UniversityBeijing 100084China faculty of medicine and pharmaceutical sciences Zhejiang UniversityHangzhou 310014China Department of Life sciences National Natural Science Foundation of ChinaBeijing 100085China

Neuroimmunology is an interdisciplinary branch of biomedical science that emerges from the intersection of studies on the nervous system and the immune *** complex interplay between the two systems has long been *** efforts directed at the underlying functional interface and associated pathophysiology,however,have garnered attention only in recent *** this narrative review,we highlight significant advances in research on neuroimmune interplay and modulation.A particular focus is on early-and middle-career neuroimmunologists in China and their achievements in frontier areas of"neuroimmune interface","neuro-endocrine-immune network and modulation","neuroimmune interactions in diseases","meningeal lymphatic and glymphatic systems in health and disease",and"tools and methodologies in neuroimmunology research".Key scientific questions and future directions for potential breakthroughs in neuroimmunology research are proposed.

关键词： Neuroimmunology Neuroimmune interplay Neuro-endocrine-immune network Basic research Key scientific questions

Cardiovascular health awareness,risk perception,behavioural intention and INTERHEART risk stratification among middle-aged adults in Malaysia

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Asian Pacific Journal of Tropical medicine 2024年第2期17卷 61-70页

作者： Siew-Keah Lee Ang-Lim Chua Clement Heng Yew Fong Ban Hao Brian Cong Wen Ling Ng Jing Feng Kong Yik-Ling Chew Kai Bin Liew Yang Shao M.Kandiah faculty of medicine and Health sciences Universiti Tunku Abdul RahmanMalaysia faculty of medicine Universiti Teknologi MARAMalaysia faculty of pharmaceutical sciences UCSI UniversityMalaysia faculty of Pharmacy University of CyberjayaMalaysia The First Affiliated Hospital of Hainan Medical University China

Objective:To investigate the interrelationship between cardiovascular health awareness,risk perception,behavioural intention,and INTERHEART risk stratification in a middle-aged adult population in ***:A cross-sectional survey with convenience sampling was conducted during November 2022 and January *** completed validated questionnaires assessing cardiovascular health awareness,risk perception of cardiovascular diseases,behavioural intention towards adopting healthy habits,and INTERHEART risk stratification score(IHRS)based on established risk factors.A total of 602 respondents were included in the final *** were analysed with independent t-test/one-way ANOVA or Mann-Whitney/Kruskal-Wallis to test the differences,Pearson correlation or linear regression test to analyze the association of independent and dependent ***:There was a significant positive correlation between medical knowledge related to cardiovascular disease(CVD)and knowledge related to CVD risk prevention,risk perception,behavioural intention and IHRS(P<0.05,Pearson correlation).Notably,individuals with higher IHRS tended to have lower knowledge related to CVD and CVD risk prevention,risk perception,and behavioural ***,laborers,active/former smokers,individuals with lower household income and educational levels,those involved in occupations not related to the healthcare sector,and those who did not receive the CVD health brochure or are unaware of health self-assessment tools are likely to have lower levels of knowledge,risk perception,and poorer behavioural intention regarding cardiovascular health(P<0.05,one-way ANOVA).While educational level,smoking status,awareness about CVD poster,self-assessment tools were repeatedly significantly associated with knowledge related to CVD and CVD risk prevention,risk perception,behavioral intention and/or IHRS(P<0.05,linear regression).Conclusions:These findings underscore the importance of promoting car

关键词： Cardiovascular risk Knowledge Risk perception Behavioural intention INTERHEART Middle-aged Lifestyle Physical activity Psychosocial stress

Satellite glial cells in sensory ganglia play a wider role in chronic pain via multiple mechanisms

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Neural Regeneration Research 2024年第5期19卷 1056-1063页

作者： Xiaoyun Qiu Yuanzhi Yang Xiaoli Da Yi Wang Zhong Chen Cenglin Xu Key Laboratory of Neuropharmacology and Translational medicine of Zhejiang Province School of Pharmaceutical ScienceZhejiang Chinese Medical UniversityHangzhouZhejiang ProvinceChina

Satellite glial cells are unique glial cells that surround the cell body of primary sensory *** increasing body of evidence suggests that in the presence of inflammation and nerve damage,a significant number of satellite glial cells become activated,thus triggering a series of functional *** suggests that satellite glial cells are closely related to the occurrence of chronic *** this review,we first summarize the morphological structure,molecular markers,and physiological functions of satellite glial ***,we clarify the multiple key roles of satellite glial cells in chronic pain,including gap junction hemichannel Cx43,membrane channel Pannexin1,K channel subunit 4.1,ATP,purinergic P2 receptors,and a series of additional factors and their receptors,including tumor necrosis factor,glutamate,endothelin,and ***,we propose that future research should focus on the specific sorting of satellite glial cells,and identify genomic differences between physiological and pathological *** review provides an important perspective for clarifying mechanisms underlying the peripheral regulation of chronic pain and will facilitate the formulation of new treatment plans for chronic pain.

关键词： chronic pain primary sensory neurons satellite glial cells sensory ganglia

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Symptomatic bradycardia in tuberculosis-related giant bullae(vanishing lung syndrome):A case report

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Asian Pacific Journal of Tropical medicine 2024年第9期17卷 425-428页

作者： Reynard Laysandro Jessie Julian Mila Meha Resley Ongga Mulia Mikha Nazamta Yusfiatuzzahra School of medicine and Health science Atma Jaya Catholic University of Indonesia JakartaIndonesia faculty of medicine and Veterinary medicine University of Nusa Cendana East Nusa TenggaraIndonesia faculty of medicine Trisakti University JakartaIndonesia

Rationale:Vanishing lung syndrome is rare and can be associated with a history of smoking and marijuana *** occurrence of giant bullae can also be linked to infections,particularly tuberculosis in tropical *** concerns:A 26-year-old male complained of weakness,severe vomiting,and reduced breathlessness when lying on the left *** had a history of pulmonary tuberculosis two years ***:Symptomatic bradycardia in tuberculosis-related giant ***:The patient was recommended to undergo an elective bullectomy,but he decided not to proceed with the *** sulfate was administered to alleviate symptoms of bradycardia,while a standardized anti-tuberculosis regimen were started for the next six ***:Following 7 days of intensive care treatment involving antituberculosis medications and atropine sulfate,the patient achieved hemodynamic stability,opting against bullectomy despite residual symptoms of *** six months of antituberculosis therapy notably alleviated symptoms without requiring ***:Increasing intrathoracic pressure can also be caused mechanically by giant *** symptoms in vanishing lung syndrome are reversible and can be alleviated once the underlying cause is *** this case,symptomatic bradycardia was reduced only with tuberculosis treatment without bullectomy intervention。

关键词： Bradycardia Infected giant bullae Tuberculosis Vanishing lung syndrome

A new hydrophobic deep eutectic solvent composed of menthol and tris(2-ethylhexyl) phosphate for solvent bar microextraction of parabens from biological fluids

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Emerging Contaminants 2024年第2期10卷 135-145页

作者： Nabil N.AL-Hashimi Husam Abed Alfattah Khaleel I.Assaf Asma A.Fakhoury Saja H.Hamed Amjad H.El-Sheikh Khairi M.Fahelelbom The Hashemite University Faculty of Pharmaceutical SciencesDepartment of Pharmaceutical ChemistryP.O.Box 330127Zarqa13133Jordan The Hashemite University Faculty of ScienceDepartment of ChemistryP.O.Box 150459Zarqa13115Jordan Al-Balqa Applied University Faculty of ScienceDepartment of Chemistry19117 Al-SaltJordan The Hashemite University Faculty of Pharmaceutical SciencesDepartment of Pharmaceutics and Pharmaceutical TechnologyP.O.Box 330127Zarqa13133Jordan Al Ain University College of PharmacyDepartment of Pharmaceutical SciencesP.O.Box 64141Al AinAl AinUnited Arab Emirates

Parabens are antimicrobial preservatives with extensive applications in cosmetics,toiletries,pharmaceuticals,and *** the legitimate concerns relating to their potential to disrupt multiple endocrine functions,it becomes imperative to prioritize the development of innovative bioanalytical techniques for effectively monitoring their presence in biological *** this study,an efficient solvent bar microextraction(SBME)was established,utilizing new hydrophobic deep eutectic solvents(DEs)to determine methylparaben and propylparaben in urine and plasma *** DEs comprising menthol and tris(2-ethylhexyl)phosphate(M-TEHP)at various molar ratios were synthesized for the first time to enhance the extraction capacity and promote the eco-friendliness of the DE used as an extraction ***-transform infrared(FT-IR)and proton nuclear magnetic resonance(1H NMR)spectroscopies were employed to confirm and investigate the properties of the successful synthesis(M-TEHP)DE at a molar ratio of 1:*** synthesized DE exhibits low microbial toxicity and can be considered an eco-friendly solvent for ***,quantum-chemical calculations were utilized to predict synthesized DE's structure and interaction energy with selected *** influential operational factors of DE-SBME on the extraction efficiency(EE%)of both parabens were evaluated using response surface methodology based on central composite design,and a total of 30 extraction tests were conducted to determine the optimal *** optimized DE-SBME,in combination with HPLC-DAD,exhibited low detection limits(0.54–0.91μg L^(−1)),excellent linearity(R^(2)≥0.9993),precise results(RSDs≤7.6%),satisfactory recoveries(92–97%)and negligible matrix ***,it had remarkable effectiveness and applicability in determining selected parabens in real urine and plasma samples.

关键词： Hydrophobic deep eutectic solvent Solvent bar microextraction Parabens Response surface methodology and central composite design HPLC-DAD Urine and plasma