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Development and Influencing Factors of Compliance Behaviors of Investigators in Clinical Trials

Journal of Huazhong University of Science and Technology(Medical Sciences) 2014年第2期34卷 284-288页

作者：沈玉红李茂忠张新平李正奇王利军 School of Medicine and Health Management Tongji Medical College Huazhong University of Science and Technology China food and drug administration China food and drug administration Center for Certification of drug

The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cron- bach＇s alpha coefficient and structural equation modeling were adopted to empirically analyze the re- suits. Six variables in the hypothetical model were included： compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality con- trol of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality con- trol of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical in- stitutinn wan only influenced by capability of government regulation.

关键词： clinical trials compliance behavior of investigator structural equation modeling ques-tionnaire survey

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Enhanced dissolution of poorly soluble antiviral drugs from nanoparticles of cellulose acetate based solid dispersion matrices

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Asian Journal of Pharmaceutical Sciences 2017年第6期12卷 532-541页

作者： Sonal Mazumdera Ashish Kumar Dewangan Naresh Pavurala Department of Chemical Engineering Birla Institute of Science and TechnologyPilaniRajasthan 333031India Oak Ridge Associated Universities Food and Drug AdministrationSilver SpringMDUSA

Polysaccharide-based polymers were used to produce nanoparticles of poorly soluble antiviral drugs using a rapid precipitation process. The structure-property relationships of four novel cellulose acetate-based polymers were studied for their solubility enhancement of poorly soluble drugs. Particles were purified by dialysis, and dried powders were recovered after freeze-drying. The particle diameters were 150–200 nm. The target drug loading in the particles was 25 wt%, and the drug loading efficiencies were 80–96%. The effects of the formulation process and nanoparticle properties on drug solubility were investigated. All nanoparticles afforded increased solubility and faster release compared to pure drugs. drug release was a function of the relative hydrophobicity (or solubility parameters) of the *** and hosting by Elsevier B.V. on behalf of Shenyang Pharmaceutical University.

关键词： Solid dispersions Ritonavir Efavirenz Nanoparticles Precipitation Solubility

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Real time monitoring of bioreactor mAb IgG3 cell culture process dynamics via Fourier transform infrared spectroscopy： Implications for enabling cell culture process analytical technology

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Frontiers of Chemical Science and Engineering 2015年第3期9卷 386-406页

作者： Huiquan Wu Erik Read Maury White Brittany Chavez Kurt Brorson Cyrus Agarabi Mansoor Khan Division of Product Quality Research (DPQR HFD-940) Office of Testing and Research (OTR) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA) Federal Research Center at White Oak 10903 New Hampshire Ave Silver Spring MD 20993 USA Process Assessment Branch II Division of Process Assessment 1 (DPA 1) Office of Process and Facilities (OPF) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA) Federal Research Center at White Oak 10903 New Hampshire Ave Silver Spring MD 20993 USA Division of Biotechnology Review and Research II (DBRRII) Office of Biotechnology Products (OBP) Office of Pharmaceutical Quality (OPQ) Center for' Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA) Federal Research Center at White Oak 10903 New Hampshire Ave Silver Spring MD 20993 USA

Compared to small molecule process analytical technology （PAT） applications, biotechnology product PAT applications have certain unique challenges and opportunities. Understanding process dynamics of bioreactor cell culture process is essential to establish an appropriate process control strategy for biotechnology product PAT applications. Inline spectroscopic techniques for real time monitoring of bioreactor cell culture process have the distinct potential to develop PAT approaches in manufac- turing biotechnology drug products. However, the use of inline Fourier transform infrared （FTIR） spectroscopic techniques for bioreactor cell culture process monitoring has not been reported. In this work, real time inline FTIR Spectroscopy was applied to a lab scale bioreactor mAb IgG3 cell culture fluid biomolecular dynamic model. The technical feasibility of using FTIR Spectroscopy for real time tracking and monitoring four key cell culture metabolites （including glucose, glutamine, lactate, and ammonia） and protein yield at increasing levels of complexity （simple binary system, fully formulated media, actual bioreactor cell culture process） was evaluated via a stepwise approach. The FTIR fingerprints of the key metabolites were identified. The multivariate partial least squares （PLS） calibration models were established to correlate the process FTIR spectra with the concentrations of key metabolites and protein yield of in-process samples, either individually for each metabolite and protein or globally for all four metabolites simultaneously. Applying the 2＇ld derivative pre-processing algorithm to the FTIR spectra helps to reduce the number of PLS latent variables needed significantly and thus simplify the interpretation of the PLS models. The validated PLS models show promise in predicting the concentration profiles of glucose, glutamine, lactate, and ammonia and protein yield over the course of the bioreactor cell culture process. Therefore, this work demonstrated the t

关键词： process analytical technology (PAT) Fouriertransform infrared (FTIR) spectroscopy partial least squares (PLS) regression mouse IgG3 bioreactor cell culture process real time process monitoring

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肺部给药疫苗装置的研究进展(英文)

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北京大学学报（医学版） 2012年第5期44卷 683-687页

作者：吕冬梅 Office of Generic drugs Center of Drug Evaluation and ResearchFood and Drug AdministrationRockville

讨论了可用于肺部给药疫苗的装置,描述了采用气溶胶进行肺部给药激发免疫的可能性。从疫苗的稳定性和抗原性来看,气溶胶装置为免疫接种提供了另外一个可行的途径。同时,肺部给药作为疫苗接种的一种途径,其非侵入性以及其相对的安全性和... 详细信息

讨论了可用于肺部给药疫苗的装置,描述了采用气溶胶进行肺部给药激发免疫的可能性。从疫苗的稳定性和抗原性来看,气溶胶装置为免疫接种提供了另外一个可行的途径。同时,肺部给药作为疫苗接种的一种途径,其非侵入性以及其相对的安全性和低成本特性也给公共卫生提供了光明的前景。

关键词：气雾剂疫苗雾化器和汽化器粉剂吸入

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The Third World Integrative Medicine Congress Abstracts (Excerption)

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Chinese Journal of Integrative Medicine 2008年第1期14卷 67-70页

作者： [Anonymous] Office of Medical Policy Center for Drug Evaluation and Research Food and Drug Administration USA Office of drug Evaluation l Center for Drug Evaluation and Research Food and Drug Administration USA Department of Pharmacology Yale University School of Medicine USA Faculty Extension/Rehibilitation/Pharmacy University of Alberta Canada Division of Rheumatology Faculty of Medicine University of British Columbia Division of Traditional Chinese Medicine Research The Arthritis Research Centre of Canada Canada Medical Director Odense University Hospital Denmark

The 3rd World Integrative Medicine Congress(3rd WIMCO)was held on September 22-24,2007 in Guangzhou,*** Congress has showed the academic achievements of integrative medicine in the recent five years covering a wide range of fields,such as basic and experimental research; clinical research;theory,education and management research;new drug research and development; and application of evidence-based *** than 1 200 participants from 15 countries and regions attended the Congress to represent their achievements,communicate their experiences and offer chances for further *** would like to select some abstracts here to share their presentations in all the above fields with the readers of Chinese Journal of Integrative Medecine.

关键词： World Excerption The Third World Integrative Medicine Congress Abstracts

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Fabrication of narrow pulse passively Q-switched self-stimulated Raman laser with c-cut Nd:GdVO_4

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Optoelectronics Letters 2016年第6期12卷 430-432页

作者：申高李祚涵韩鸣 Center for Medical Device Evaluation China Food and Drug Administration Key Laboratory of Luminescence and Optical Information of Ministry of Education Institute of Laser School of Science Beijing Jiaotong University

Combining the self-stimulated Raman scattering technology and saturable absorber of Cr^(4+):YAG, a 1.17 μm c-cut Nd:GdVO_4 picosecond Q-switched laser is demonstrated in this paper. With an incident pump power of 10 W, the Q-switched laser with average power of 430 mW for 1.17 μm, pulse width of 270 ps, repetition rate of 13 kHz and the first order Stokes conversion efficiency of 4.3% is obtained. The Q-switched pulse width can be the narrowest in our research. In addition, the yellow laser at 0.58 μm is also achieved by using the LiB_3O_5 frequency doubling crystal.

关键词： switched repetition absorber yellow doubling Stokes coated stimulated mirror narrow

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Guidelines and strategy of the International Conference of Harmonization(ICH) and its member states to overcome existing impurity control problems for antibiotics in China

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Chinese Journal of Natural Medicines 2015年第7期13卷 498-506页

作者： JIANG Yu XIA Jun-Ping YANG Jian-Hong ZHANG Zhe-Feng HU Chang-Qin ZHANG Zhi-Rong Key Laboratory of drug Targeting and drug Delivery System Ministry of EducationWest China School of PharmacySichuan University Center for drug Evaluation China Food and Drug Administration China Pharmaceutical University China National Institutes for food and drug Control

In the present report,we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies,including the International Conference of Harmonization(ICH),the US food and drug administration(FDA),the European Medicines Agency(EMA) and the China food and drug administration(CFDA).Progresses with the US Pharmacopoeia(USP),the European Pharmacopoeia(EP) and the Chinese Pharmacopoeia(ChP) to control impurities in antibiotics are also ***,our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics,and the implementation of ICH,FDA and other technical guidelines for generic drugs impurity control in *** problems are further reviewed,in order to improve the overall process for the control of antibiotic

关键词： China Impurity control Antibiotics Bridging Guidelines

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Changes of spring wind erosion based on wind erosion climate factor in the black soil region of Northeast China

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Journal of Mountain Science 2023年第6期20卷 1712-1724页

作者： YAN Ping JI Sheng-tai LI Xiu-fen ZHU Hai-xia WANG Liang-liang ZHAI Mo WANG Ping ZHAO Hui-ying Heilongjiang Institute of Meteorological Sciences Harbin 150030China Innovation and Open Laboratory of Eco-meteorology in Northeast China China Meteorological AdministrationHarbin 150030China Heilongjiang Ecological Meteorological Center Harbin 150030China

The dry and windy climate and low ground cover in spring in the black soil region of Northeast China make the soil strongly affected by wind erosion,which seriously threatens the food security and ecological security of this *** this paper,based on the daily observation data of 124 meteorological stations in study area from 1961 to 2020,seasonal and monthly wind erosion climate factor(C)in spring(March to May)were calculated by using the method proposed by the food and Agriculture Organization of the United Nations(FAO),the wind erosion characterization in spring were systematically analyzed based on C by various statistical analysis *** results showed that in the past 60 years,spring wind erosion climate factor(CSp)and monthly C of the whole region and each province(region)all showed highly significant decreasing trend,but they began to show rebounded trend in the middle or late *** of the study area showed a significant upward trend since 2008 with an increase of 4.59(10a)^(-1).The main contributors to this upward trend are the changes of C in March and in *** the four provinces(regions),CSp in Heilongjiang,Jilin,Liaoning and eastern Inner Mongolia all showed rebounded since 2008,2011,2008 and 2009,*** rebounded trend of CSp in eastern Inner Mongolia was the most obvious with a tendency rate of 11.27(10a)^(-1),and its mutation occurred after *** rebound trend of CSp in Heilongjiang Province takes the second place,with a trend rate of 4.72(10a)^(-1),but there’s no obvious time mutation *** spatial characteristics of CSpand monthly C are similar,showing decreasing characteristics centered on the typical black soil belt of Northeast *** with 1961-1990,in the period from 1991 to 2020,the proportion of high value areas(CSp>35,monthly C>10)has decreased to varying degrees,while the proportion of low value areas(CSp≤10,monthly C≤4)has *** trends of seasonal and monthly C in 82.2%~87.7%of the

关键词： Wind erosion climate erosivity Spatiotemporal 1characteristics Climate change Rebounded trend Typical black soil region Northeast China

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Simultaneous Determination of Hexoestrol, Diethylstilbestrol, Estrone and 17-Beta-estradiol in Feed by Gas Chromatography-mass Spectrometry

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Journal of Northeast Agricultural University(English Edition) 2016年第1期23卷 44-49页

作者： Huo Feng Li Ning Lin Xiao-Li Institute of Veterinary drug and food Control Harbin 150010 China

A method was developed for the simultaneous determination of four kinds of estrogens （hexoestrol, diethylstilbestrol, estrone, and 17-beta-estradiol） in feed by gas chromatography-mass spectrometry （GC-MS）. After the sample was extracted by ethyl ether and cleaned-up on HLB phase extraction column, four kinds of estrogens were derived and quantified in gas chromatographymass spectrometry. The results showed that the linear detectable ranged from 2.5 ng· mL-1 to 250 ng· mL-1for hexoestrol and from 5 ng· mL-1 to 500 ng· mL-1 for three other estrogens with the correlation coefficients （R2） were no less than 0.990. The recoveries were in the range of 76.34%-96.33% and the relative standard deviation was no more than 22.7%. The limits of quantitation （LOQ） for all analytics were between 10 ug· kg^-1 and 20 ug· kg^-1. The method was accurate and sensitive and could meet the actual requirements for the analyses of feed samples.

关键词： gas chromatography-mass spectrometry hexoestrol diethylstilbestrol estrone 17-beta-estradiol feed

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Effect of Shenqi Compound Formula on PPARγ in White Adipose Tissue of Rats with Macrovascular Lesion in Early Stage of Diabetes

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Journal of Traditional Chinese Medicine 2008年第2期28卷 134-138页

作者：张红敏谢春光陈世伟谢毅强王友京（译） West China Hospital of Sichuan University Chengdu 610041 China Chengdu University of Traditional Chinese Medicine China food and drug administration of Henan China 不详

Objective:To investigate the effect of Shenqi Compound Formula (SCF) on peroxisome proliferators-activated receptor γ (PPARγ) in white adipose tissue of rats with macrovascular lesion in early stage of diabetes. Methods: Corresponding treatment was given to rats in model group, Ramipril group, normal control group, low dosage SCF group and high dosage SCF group respectively for 32 days. The expressions of PPARγ and adiponectin Messenger RNA (mRNA) were detected by real-time reverse transcriptase poly-merase chain reaction. Results: The expressions of PPARγ and adiponectin mRNA increased significantly in both low and high dosage SCF groups as compared with the model group, and a positive linear correlation was found between the expressions of PPARγ and adiponectin mRNA. Conclusions: SCF can prevent macrovascular lesion in early stage of diabetes, which is possibly related with up-regulating expressions of PPARγ and activating PPARγ.

关键词： Shenqi Compound Formula TypeⅡ Diabetes Macrovascular lesion Peroxisome proliferators-activated receptor γ (PPARγ)

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