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Ancylostoma ceylanicum and other zoonotic canine hookworms:neglected public and animal health risks in the Asia-Pacific region

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Animal Diseases 2024年第1期4卷 59-74页

作者： Jan Clyden B.Tenorio lan Kim B.Tabios Tawin Inpankaew Adrian P.Ybanez Saruda Tiwananthagorn Sirikachorn Tangkawattana Sutas Suttiprapa Tropical Medicine Graduate Program Faculty of MedicineKhon Kaen UniversityKhon Kaen 40002Thailand Department of Tropical Medicine Faculty of MedicineKhon Kaen UniversityKhon Kaen 40002Thailand WHO Collaborating Center for Research and Control of Opisthorchiasis(Southeast Asian Liver Fluke Disease) Tropical Disease Research CenterKhon Kaen UniversityKhon Kaen 40002Thailand Department of veterinary Paraclinical Sciences College of Veterinary MedicineUniversity of Southern MindanaoKabacan9407 CotabatoPhilippines Institute of Biology College of ScienceUniversity of the Philippines DilimanManila 1101Philippines Department of Parasitology Faculty of Veterinary MedicineKasetsart UniversityBangkok 10900Thailand College of veterinary Medicine at Barili Campus and Center for Vector-Borne and Protozoan Diseases at Main Campus Cebu Technological UniversityCebu City 6000Philippines Department of veterinary Biosciences and Public Health Faculty of Veterinary MedicineChiang Mai UniversityChiang Mai 50100Thailand Research Center for veterinary Biosciences and veterinary Public Health Chiang Mai UniversityChiang Mai 50100Thailand Faculty of veterinary Medicine Khon Kaen University.Khon Kaen 40002Thailand

Zoonotic hookworm infections remain a significant public health problem,causing nearly 500 milion cases globally and approximately four million disability-adjusted life years lost *** than one-fth of these cases are attrib-uted to Ancylostoma ceylanicum,an emerging zoonotic health issue in the Asia-Pacific *** review presents key research gaps regarding the epidemiology,diagnosis,control,prevention and elimination of *** and other canine zoonotic hookworms as neglected health *** is the second most prevalent human hook-worm in the region;it is the most common hookworm among dogs and cats-reservoirs of zoonotic *** population genetic and phylogenetic analyses revealed that *** has three possible transmis-sion dynamics:zoonotic,animal-only,and human-only *** actual burden of zoonotic ancylostomiasis in most endemic countries remains unknown due to the use of parasitological techniques(e.g.,Kato-Katz thick smear and floatation techniques)that have reduced diagnostic performance and do not allow accurate species identifica-tion in helminth *** emergence of benzimidazole resistance in soil-transmitted helminths(STHs),includ-ing hookworms,is a concern due to the protracted implementation of mass drug administration(MDA).Resistance is conferred by single nucleotide polymorphisms(SNPs)that occur in theβ-tubulin isotype 1 *** mutations have been reported in drug-resistant *** but have not been found in *** in the *** remains understudied in the Asia-Pacific *** zoonotic nature of the parasite warrants investigation of its occur-rence in human and animal reservoir hosts to understand the dynamics of zoonotic transmission in different endemic *** detection of benzimidazole resistance-associated SNPs in zoonotic hookworms from Asia-Pacific countries has yet to be thoroughly *** the high level of hookworm endemicity in the region

关键词： Soil-transmitted helminths Neglected tropical diseases Mass drug administration Deworming veterinary public health

New era of drug innovation in China

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Acta Pharmaceutica Sinica B 2019年第5期9卷 1084-1085页

作者： Xuan Ye Qingli Wang Haixue Wang office of Pharmacology and Toxicology Center for drug Evaluation National Medical Products Administration

In 2018, the China National Medical Products administration(NMPA) approved new drug applications (NDAs) of 48 new drugs, which was the highest annual approval rate by the Chinese regulatory agency in the past 20 years. Nine of the 48 new drugs,including fruquintinib, anlotinib, toripalimab and sintilimab, are global new molecular entities (NME) that were developed by Chinese pharmaceutical companies.

关键词： New era drug innovation China

Amphotericin B release rate is the link between drug status in the liposomal bilayer and toxicity

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Asian Journal of Pharmaceutical Sciences 2022年第4期17卷 544-556页

作者： Yuri Svirkin Jaeweon Lee Richard Marx Seongkyu Yoon Nelson Landrau Md Abul Kaisar Bin Qin Jin H.Park Khondoker Alam Darby Kozak Yan Wang Xiaoming Xu Jiwen Zheng Benjamin Rivnay Landrau Scientific Innovations LeominsterMAUnited States of America University of Massachusetts Lowell LowellMAUnited States of America office of Research and standards Office of Generic DrugsCenter for Drug Evaluation and ResearchU.S.Food and Drug AdministrationSilver SpringMDUnited States of America office of Testing and Research Office of Pharmaceutical QualityCenter for Drug Evaluation and ResearchU.S.Food and Drug AdministrationSilver SpringMDUnited States of America office of Science and Engineering Laboratories Center for Devices and Radiological HealthU.S.Food and Drug AdministrationSilver SpringMDUnited States of America

Amphotericin B(AmB)is an amphiphilic drug commonly formulated in liposomes and administered intravenously to treat systemic fungal *** studies on the liposomal drug product have shed light on the AmB aggregation status in the bilayer,which heat treatment(curing)*** toxicity was found related to aggregation status-loose aggregates significantly more toxic than tight aggregates-the precise mechanism linking aggregation and toxicitywas notwell *** study directlymeasured drug release rate fromvarious AmB liposomal preparations made with modified curing protocols to evaluate correlations among drug aggregation state,drug release,and in vitro ***–Vis spectroscopy of these products detected unique curing-induced changes in the UV spectral features:a∼25nm blue-shift of the main absorption peak(λ_(max))in aqueous buffer and a decrease in the OD_(346)/OD_(322) ratio upon thermal curing,reflecting tighter *** vitro release testing(IVRT)data showed,by applying and fitting first-order release kinetic models for one or two pools,that curing impacts two significant changes:a 3–5-fold drop in the overall drug release rate and a ten-fold decrease in the ratio between the loosely aggregated and the tightly aggregated,more thermodynamically stable drug *** kinetic data thus corroborated the trend independently deduced from the UV–Vis spectral *** in vitro toxicity assay indicated a decreased toxicity with curing,as shown by the significantly increased concentration,causing half-maximal potassium release(TC50).The data suggest that the release of AmB requires dissociation of the tight complexes within the bilayer and that the reduced toxicity relates to this slower rate of *** study demonstrates the relationship between AmB aggregation status within the lipid bilayer and drug release(directly measured rate constants),providing a mechanistic link between aggregation status and in vitro toxicity in the lip

关键词： Amphotericin B UV–Vis Spectrum drug Release In Vitro Toxicity Aggregation Status Liposomes

Repurposing Loperamide as an Anti-Infection drug for the Treatment of Intracellular Bacterial Pathogens

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Engineering 2024年第8期39卷 180-193页

作者： Hongtao Liu Siqi Li Le Deng Zhenxu Shi Chenxiao Jiang Jingyan Shu Yuan Liu Xuming Deng Jianfeng Wang Zhimin Guo Jiazhang Qiu State Key Laboratory for Diagnosis and Treatment of Severe Zoonotic Infectious Diseases&Key Laboratory of Zoonosis Research Ministry of EducationInstitute of ZoonosisCollege of Veterinary Medicine&Jilin UniversityChangchun 130062China Center for Pathogen Biology and Infectious Diseases The First Hospital of Jilin UniversityChangchun 130031China Jiangsu Co-Innovation Center for Prevention and Control of Important Animal Infectious Diseases and Zoonoses Institute of Comparative MedicineCollege of Veterinary MedicineYangzhou UniversityYangzhou 225009China

Infections caused by intracellular bacterial pathogens are difficult to treat since most antibiotics have low cell permeability and undergo rapid degradation within *** rapid development and dissemination of antimicrobial–resistant strains have exacerbated this *** the increasing knowledge of host–pathogen interactions,especially bacterial strategies for survival and proliferation within host cells,host-directed therapy(HDT)has attracted increased interest and has emerged as a promising antiinfection method for treating intracellular ***,we applied a cell-based screening approach to a US Food and drug administration(FDA)-approved drug library to identify compounds that can inhibit the intracellular replication of Salmonella Typhimurium(***).This screening allowed us to identify the antidiarrheal agent loperamide(LPD)as a potent inhibitor of *** intracellular *** treatment of infected cells markedly promoted the host autophagic response and lysosomal activity.A mechanistic study revealed that the increase in host autophagy and elimination of intracellular bacteria were dependent on the high expression of glycoprotein nonmetastatic melanoma protein B(GPNMB)induced by *** addition,LPD treatment effectively protected against *** infection in Galleria mellonella and mouse ***,our study suggested that LPD may be useful for the treatment of diseases caused by intracellular bacterial ***,LPD may serve as a promising lead compound for the development of anti-infection drugs based on the HDT strategy.

关键词： Intracellular bacteria US Food and drug administration(FDA)-approved drugs drug repurposing Loperamide Autophagy Glycoprotein nonmetastatic melanoma protein B

CD4 and CD8 T cells mediate distinct lethal meningoencephalitis in mice challenged with Tacaribe arenavirus

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Cellular & Molecular Immunology 2017年第1期14卷 90-106页

作者： Derek DC Ireland Cecilia Tami Joao Pedras-Vasconcelos Daniela Verthelyi Division of Biologics Review and Research-III Office of Biotechnology Center for Drug Evaluation and Research Food and Drug Administration Silver Spring MD 20993 USA

Neonates are at increased risk of viral encephalopathies that can result in neurological dysfunction, seizures, permanent disability and even death. The neurological damage results from the combined effect of the virus and the immune response it elicits, thus finding tools to facilitate viral clearance from central nervous system （CNS） while minimizing neuron damage remains a critical challenge. Neonatal mice inoculated intraperitoneally with Tacaribe virus （TCRV） develop seizures, hindlimb paralysis and death within 15 days of inoculation. TCRV localizes to the CNS within days of challenge, primarily infecting astrocytes in the cerebellum and brain stem. We show that infection leads to inflammation, T cell and monocyte infiltration into the cerebellar parenchyma, apoptosis of astrocytes, neuronal degeneration and loss of Purkinje cells. Infiltrating antigen-specific T cells fail to clear the virus but drive the disease, as T-cell-deficient CD3ε KO mice survive TCRV infection with minimal inflammation or clinical manifestations despite no difference in CNS viral loads in comparison with T-cell sufficient mice. CD8＋ T cells drive the pathology, which even in the absence of CD4＋ T-cell help, infiltrate the parenchyma and mediate the apoptotic loss of cerebellar astrocytes, neurodegeneration and loss of Purkinje cells resulting in loss of balance, paralysis and death. CD4＋ T cells are also pathogenic inducing gliosis and inflammation in the cerebellum and cerebrum that are associated with wasting and death several weeks after CD4＋ T-cell transfer. These data demonstrate distinct pathogenic effects of CD4＋ and CD8＋ T cells and identify them as possible therapeutic targets.

关键词： Astrocytes CD4 T cells CD8 T cells encephalitis Purkinje cells virus

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

The Role of Toxicology in Evaluating Marketing Applications for Prescription drug Products in the United States

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毒理学杂志 2005年第A3期19卷 169-170页

作者： Kenneth L Hastings P.H. D.A.B.T. Associate Director Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Associate Director Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Dr.Associate Director Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration

In the United States, in order to market a prescription drug product studies need to be conducted to demonstrate safety and efficacy.

关键词：毒物学临床应用处方药代谢产物

The Role of Toxicology in Evaluating Marketing Applications for Prescription drug Products in the United States

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毒理学杂志 2005年第S1期 169-170页

作者： Kenneth L Hastings,P.H.,D.A.B.T. Associate Director office of New drugs Center for drug Evaluation and Research US Food and drug administration Associate Director office of New drugs Center for drug Evaluation and Research US Food and drug administration Dr. Associate Director office of New drugs Center for drug Evaluation and Research US Food and drug administration

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