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the Role of toxicology in Evaluating Marketing Applications for prescription drug products in the United States

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

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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

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diurnal variation in fecal concentrations of acid-detergent insoluble ash and alkaline-peroxide lignin from cattle fed bermudagrass hays of varying nutrient content

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Journal of Animal Science and biotechnology 2015年第4期6卷 410-415页

作者： Juvenal Kanani dirk philipp kenneth p Coffey Elizabeth b Kegley Charles p West Shane Gadberry John Jennings Ashley N Young Robert t Rhein division of Agriculture University of Arkansas department of plant and Soil Science Texas Tech University

background： the effect of time of fecal sampling on the accuracy of acid-detergent insoluble ash （AdIA） and alkaline-peroxide lignin （Apl） for the prediction of fecal output （FO） in cattle was evaluated. Eight ruminally cannulated cows （594 _＋ 35.5 kg） were allocated randomly to 4 bermudagrass [Cynodon dactylon （l.） pers.] hay diets markedly different in crude protein concentration （79-164 g/kg） with 2 replicates per diet for 3 periods. Cows were offered hay individually at 20 g dM/kg of body weight daily in equal feedings at 08：00 and 16：00 h for a 10-d adaptation period followed by 5-d of total fecal collection. Fecal grab samples also were taken each day during the fecal collection period at 06：00, 12：00, 18：00, and 24：00 h either directly from the rectum or from freshly voided feces. Samples were composited within cow and time across the 5 d total fecal collection period. Additionally, forage, ort, and fecal samples were analyzed for concentrations of Apl and AdIA. Results： Fecal concentrations of AdIA and Apl were not affected by sampling time （p 〉 0.22）, even though diet affected （p 〈 0.01） fecal AdIA and Apl concentrations. there were no diet x sampling time interactions （p ≥ 0.60）. Estimates of FO and dry matter digestibility （dMd） from AdIA and Apl were not affected （p 〉 0.16） by sampling time or the diet x sampling time interaction （p 〉 0.74）. Estimates of FO and dMd from markers from different sampling times or all different combinations of sampling time were not different （p 〉 0.72） from those of total collection among internal markers. Conclusion： little variation in concentrations of AdIA and Apl in daily fecal excretion across time increases flexibility in fecal grab sampling schedules for predicting FO and dMd.

关键词： digestibility Fecal sampling time Internal markers bermudagrass Cattle

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Well-posedness of Stochastic Continuity Equations on Riemannian Manifolds

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Chinese Annals of Mathematics,Series b 2024年第1期45卷 81-122页

作者： luca GAlIMbERtI kenneth h.KARlSEN department of Mathematical Sciences NTNU Norwegian University of Science and TechnologyN-7491 TrondheimNorway department of mathematics University of OsloP.O.Box 1053BlindernN-0316 OsloNorway

the authors analyze continuity equations with Stratonovich stochasticity,■ρ+divh[ρo(u(t,x)+∑_(i=1)^(N)a_(i)(x)w_(i)(t))]=0defined on a smooth closed Riemannian manifold M with metric *** velocity field u is perturbed by Gaussian noise terms Wi(t),:WN(t)driven by smooth spatially dependent vector fields a1(x),...,aN(x)on *** velocity u belongs to l_(t)^(1)W_(x)^(1,2)with divh u bounded in lf,for p>d+2,where d is the dimension of M(they do not assume div_(h) u∈l_(t,x)^(∞)).For carefully chosen noise vector fields ai(and the number N of them),they show that the initial-value problem is well-posed in the class of weak l^(2) solutions,although the problem can be ill-posed in the deterministic case because of concentration *** proof of this“regularization by noise”result is based on a l^(2) estimate,which is obtained by a duality method,and a weak compactness argument.

关键词： Stochastic continuity equation Riemannian manifold hyperbolic equa-tion Non-smooth velocity field Weak solution Existence Uniqueness

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Comparison of acid-detergent lignin,alkaline-peroxide lignin,and acid-detergent insoluble ash as internal markers for predicting fecal output and digestibility by cattle offered bermudagrass hays of varying nutrient composition

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Journal of Animal Science and biotechnology 2014年第3期5卷 310-317页

background： the potential for acid-detergent insoluble ash （AdIA）, alkaline-peroxide lignin （Apl）, and acid-detergent lignin （Adl） to predict fecal output （FO） and dry matter digestibility （dMd） by cattle offered bermudagrass [Cynodon doctylon （l） pers.] hays of different qualities was evaluated. Eight ruminally cannulated cows （594 ± 35.5 kg） were allocated randomly to 4 hay diets： low （l）, medium low （Ml）, medium high （Mh）, and high （h） crude protein （Cp） concentration （79, 111,131, and 164 g Cp/kg on a dM basis, respectively）. diets were offered in 3 periods with 2 diet replicates per period and were rotated across cows between periods. Cows were individually fed 20 g dM/kg of body weight in equal feedings at 08：00 and 16：00 h for a 10-d adaptation followed by a 5-d total fecal collection. Actual dM intake （dMI）, dMd, and FO were determined based on hay offered, ort, and feces excreted. these components were then analyzed for Adl, Apl, and AdIA concentration to determine marker recovery and marker-based estimates of FO and dMd. Results： Forage dMI was affected by diet （p = 0.02）, and dMI from Mh and h was greater （p 〈 0.05） than from l. Apparent dMd tended （p = 0.08） to differ among diets while FO （p = 0.20） was not affected by diet treatments. Average Adl recovery （1.16） was greater （p 〈 0.05） than that of AdIA （1.03） and Apl （1.06）, but AdIA and Apl did not differ （p = 0.42）. Estimates of FO and dMd derived using Apl and AdIA were not different （p≥0.05） from total fecal collection while those using Adl differed （p 〈 0.05）. there was no diet by marker interaction （p≥ 0.22） for either FO or dMd. Conclusion： Acid-detergent insoluble ash and Apl accurately predicted FO and dMd of cattle fed bermudagrass hay of varying nutrient composition. these internal markers may facilitate studies involving large numbers of animals and forages. Results from such studies may be used to develop improved equations to predict energy values of forages based on the relationship of di

关键词： Acid-detergent insoluble ash Alkaline-peroxide lignin bermudagrass Cattle digestibility Marker

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baseline gut microbiota and metabolome predict durable immunogenicity to SARS-CoV-2 vaccines

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Signal transduction and targeted therapy 2023年第10期8卷 5085-5095页

作者： Ye peng lin Zhang Chris K.p.Mok Jessica Y.l.Ching Shilin Zhao Matthew K.l.Wong Jie Zhu Chunke Chen Shilan Wang Shuai Yan biyan Qin Yingzhi liu Xi Zhang Chun pun Cheung pui Kuan Cheong Ka long Ip Adrian C.h.Fung kenneth K.Y.Wong david S.C.hui Francis K.l.Chan Siew C.Ng hein M.tun Microbiota I-Center(MaglC) Hong KongChina Jockey Club School of public health and primary Care The Chinese University of Hong KongHong KongChina li Ka Shing Institute of health Sciences Faculty of MedicineThe Chinese University of Hong KongHong KongChina department of Medicine and therapeutics The Chinese University of Hong KongHong KongChina department of Surgery LKS Faculty of MedicineThe University of Hong KongHong KongChina Stanley ho Centre for Emerging Infectious diseases Faculty of MedicineThe Chinese University of Hong KongHong KongChina Centre for Gut Microbiota Research The Chinese University of Hong KongHong KongChina

the role of gut microbiota in modulating the durability of cOVId-19 vaccine immunity is yet to be *** this cohort study,we collected blood and stool samples of 121 bNt162b2 and 40 CoronaVac vaccinees at baseline,1 month,and 6 months post vaccination(p.v).Neutralisation antibody,plasma cytokine and chemokines were measured and associated with the gut microbiota and metabolome composition.

关键词： vaccine immunity vaccines

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Staging colorectal cancer with the tNM 7^(th):the presumption of innocence when applying the M category

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World Journal of Gastroenterology 2013年第8期19卷 1152-1157页

作者： Giacomo puppa Graeme poston per Jess Guy F Nash kenneth Coenegrachts Axel Stang Service de pathologie Clinique Hpitaux Universitaires de Genève1211 GenevaSwitzerland department of Surgery Aintree University HospitalsLiverpool L9 7ALUnited Kingdom department of Surgery Roskilde HospitalUniversity of Copenhagen2200 CopenhagenDenmark department of Colorectal Surgery Poole General HospitalPoole BH15 2JBUnited Kingdom department of Radiology AZ St.-Jan Brugge-Oostende AVB-8000 BrugesBelgium department of Oncology Hematology and Palliative CareAsklepios Hospital Hamburg-Barmbek22291 HamburgGermany

One of the main changes of the current tNM-7 is the elimination of the category MX,since it has been a source of ambiguity and misinterpretation,especially by *** the ultimate staging would be better performed by the patient's clinician who can classify the disease M0(no distant metastasis) or M1(presence of distant metastasis),having access to the completeness of data resulting from clinical examination,imaging workup and pathology *** this important change doesn't take into account the diagnostic value and the challenge of small indeterminate visceral lesions encountered,in particular,during radiological staging of patients with colorectal *** this article the diagnosis of these lesions with multiple imaging modalities,their frequency,significance and relevance to staging and disease management are described in a multidisciplinary *** particular the interplay between clinical,radiological and pathological staging,which are usually conducted independently,is *** integrated approach shows that there are both advantages and disadvantages to abandoning the MX *** avoid ambiguity arising both by applying and interpreting MX category for stage assigning,its abandoning seems *** recognition of the importance of small lesion characterization raises the need for applying a separate category;therefore a proposal for their categorization is put *** using the proposed categorization the lack of consideration for indeterminate visceral lesions with the current staging system will be overcome,also optimizing tailored follow-up.

关键词： Colorectal cancer Staging Indeterminate lesions Imaging Metastases

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phase 3 trial of first generation protease inhibitor therapy for hepatitis C virus/human immunodeficiency virus coinfection

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World Journal of hepatology 2017年第4期9卷 217-223页

作者： kenneth E Sherman Minhee Kang Richard Sterling triin Umbleja Kristen Marks Jennifer J Kiser beverly Alston-Smith Wayne Greaves Adeel A butt 无 division of digestive diseases University of Cincinnati College of Medicine harvard t.h. Chan School of public health department of Gastroenterology Virginia Commonwealth University division of Infectious disease Weill Cornell Medical School University of Colorado School of pharmacy NIAId-division of AIdS Merck and Co Inc. University of pittsburgh School of Medicine hamad healthcare Quality Institute the ACtG 5294 bIRth Study team

AIMto evaluate efficacy/safety of hepatitis C virus (hCV) protease inhibitor boceprevir with pegylated interferon (pEG-IFN) alfa and weight-based ribavirin (RbV) in a phase 3 trial. MEthOdSA prospective, multicenter, phase 3, open-label, single-arm study of pEG-IFN alfa, weight-based RbV, and boceprevir, with a pEG-IFN/RbV lead-in phase was performed. the hCV/human immunodeficiency virus coinfected study population included treatment naïve (tN) and treatment experienced (tE) patients. treatment duration ranged from 28 to 48 wk dependent upon response-guided criteria. All patients had hCV Genotype 1 with a viral load > 10000 IU/ml. Compensated cirrhosis was allowed. Sample size was determined to establish superiority to historical (pEG-IFN plus RbV) rates in sustained viral response (SVR). RESUltSA total of 257 enrolled participants were analyzed (135 tN and 122 tE). In the tN group, 81.5% were male and 54.1% were black. In the tE group, 76.2% were male and 47.5% were white. Overall SVR12 rates (hCV RNA p = 0.002). Among the tN, SVR12 was 42.1% among whites and 27.4% among blacks (p = 0.09). CONClUSIONthe trial met its hypothesis of improved SVR compared to historical controls but overall SVR rates were low. All-oral hCV treatments will mitigate these difficulties.

关键词： human immunodeficiency virus hepatitis C virus boceprevir pegylated interferon alfa Ribavirin

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