National Institute for Food and Drug Control

Beijing, China

National Institute for Food and Drug Control

Beijing, China
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Gao Z.-F.,National Institute for Food and Drug Control | Lin L.,National Institute for Food and Drug Control
Chinese Journal of New Drugs | Year: 2017

As the technical basis for government regulation and the principle for enterprise production, the drug standards have important significance to the drug inspecting institutions. However, it is difficult for quality control personnel to select a standard correctly and ensure the validity, with the existence of numerous and various of standards. In order to clarify the connotation of standard validity, we focused on three aspects of the standards in this paper, i.e., the correctness, accuracy and order. In order to obtain the composition and influencing factors, some related contents were analyzed which including the approval systems, audit departments, numbering, erratum ways, provider of standards, and so on. Then some solutions were proposed such as multi sector linkage and orderly management, which could solve the problems in the use of standards and provide a reference to the drug inspecting institutions. © 2017, Chinese Journal of New Drugs Co. Ltd. All right reserved.

Gao Z.-F.,National Institute for Food and Drug Control | Lin L.,National Institute for Food and Drug Control
Chinese Journal of New Drugs | Year: 2017

Quality evaluation of drugs is a significant method of post-marketing surveillance, meanwhile a focus of the big data strategy at present. As a result, efficient management has become a necessity to each quality control institute in the situation of limited time and heavy tasks. As an organizing unit, the Institute for Chemical Drug Control had completed the job efficiently in a standardized management mode, which was based on retrospective studies and including twelve new strategies. The idea won the second place in the Management Innovation Contest of NIFDC in 2015. In order to comb the integrated management mode, we overviewed the records in recent years and analyzed the key points of implementation. Then some solutions were proposed which could improve the efficiency of post-marketing quality evaluation of drugs greatly. © 2017, Chinese Journal of New Drugs Co. Ltd. All right reserved.

Yu K.,U.S. Food and Drug Administration | Geng X.,National Institute for Food and Drug Control | Chen M.,U.S. Food and Drug Administration | Zhang J.,U.S. Food and Drug Administration | And 3 more authors.
Drug Metabolism and Disposition | Year: 2014

Drug-induced liver injury (DILI) is complicated and difficult to predict. It has been observed that drugs with extensive hepatic metabolism have a higher likelihood of causing DILI. Cytochrome P450 (P450) enzymes are primarily involved in hepatic metabolism. Identifying the associations of DILI with drugs that are P450 substrates, inhibitors, or inducers will be extremely helpful to clinicians during the decision-making process of caring for a patient suspected of having DILI. We collected metabolism data on P450 enzymes for 254 orally administered drugs in the Liver Toxicity Knowledge Base Benchmark Dataset with a known daily dose, and applied logistic regression to identify these associations. We revealed that drugs that are substrates of P450 enzymes have a higher likelihood of causing DILI [odds ratio (OR), 3.99; 95% confidence interval (95% CI), 2.07-7.67; P < 0.0001], which is dose-independent, and drugs that are P450 inhibitors have a higher likelihood of generating DILI only when they are administered at high daily doses (OR, 6.03; 95% CI, 1.32-27.5; P = 0.0098). However, drugs that are P450 inducers are not observed to be associated with DILI (OR, 1.55; 95% CI, 0.65-3.68; P = 0.3246). Our findings will be useful in identifying the suspected medication as a cause of liver injury in clinical settings.

Sun J.,University of Macau | Sun J.,National Institute for Food and Drug Control | Bi C.,University of Macau | Chan H.M.,University of Macau | And 3 more authors.
Colloids and Surfaces B: Biointerfaces | Year: 2013

Purpose: The aim of the present study was to blend liquid lipids with solid lipids to encapsulate curcumin in solid lipid nanoparticles (SLNs), thereby improving the dispersibility and chemical stability of curcumin, prolonging its antitumour activity and cellular uptake and enhancing its bioavailability. Methods: Curcumin-loaded SLNs (C-SLNs) were prepared by high-pressure homogenisation with liquid lipid Sefsol-218®. The morphology, stability and release of curcumin in the optimised formulation were investigated. The anti-cancer activity of the formulation was evaluated in MCF-7 cells. Fluorescence spectrophotometry was used to quantify cellular uptake of the drug. The pharmacokinetic profiles of curcumin in SLNs after intravenous administration were studied in rats. Results: Blending Sefsol-218® into a lipid matrix reduced the particle size without improving drug loading. An optimised formulation consisting of Dynasan 114®, Sefsol-218®, and Pluronic F68® (630:70:300, w/w) loaded with 0.8% drug was prepared. This formulation could be dispersed in water with a mean particle size of 152.8±4.7nm and a 90% entrapment efficiency. Curcumin displayed a two-phase sustained release profile from C-SLNs with improved chemical stability. Compared to the solubilised solution, C-SLNs exhibited prolonged inhibitory activity in cancer cells, as well as time-dependent increases in intracellular uptake. After intravenous administration to rats, the bioavailability of curcumin was increased by 1.25-fold. Conclusions: C-SLNs with improved dispersibility and chemical stability in an aqueous system have been successfully developed. C-SLNs may represent a potentially useful cancer therapeutic curcumin delivery system. © 2013 Elsevier B.V.

News Article | November 2, 2016

GAITHERSBURG, MD - November 2, 2016 - The Institute for In Vitro Sciences (IIVS) welcomes the news from China Food and Drug Administration (CFDA) officials that - for the first time in China - data from a non-animal test method will soon be recognized for safety evaluations of cosmetics. The method, known as the 3T3 Phototoxicity assay, measures a chemical's potential to cause harm after exposure to light. The test has undergone formal validation internationally and has been incorporated into the OECD Test Guideline program (OECD TG #432). A subsequent inter-laboratory evaluation of the test was conducted in China with input from IIVS. Once the method is officially published by CFDA, it can be used to substantiate the safety of cosmetics, personal care products, and their ingredients. "The anticipated publication by CFDA is an extremely important step for China" says Erin Hill, Co-Founder and President of IIVS. "It clearly demonstrates China's commitment to modernize their testing requirements and reduce their reliance on animal models". IIVS and CFDA/National Institute for Food and Drug Control (NIFDC), which has regulatory authority over cosmetics in China, have been working together for several years under a Memorandum of Understanding (MOU) for scientific exchange around the use of non-animal (in vitro) methods for safety assessments. A key component of the MOU is an annual hands-on training provided by IIVS to national and provincial Institute for Food and Drug Control scientists. Over the past four years, approximately 400 regulatory scientists have been trained in methods such as phototoxicity, skin and eye irritation and skin sensitization. IIVS, together with NIFDC, is currently holding its 4th annual training at the laboratory facility of the Zhejiang Institute for Food and Drug control in Hangzhou, China. IIVS Educational and Outreach programs are made possible by funding provided by its Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA), other individual companies and animal protection organizations such as PETA. About IIVS IIVS is a non-profit organization wholly dedicated to the promotion of rapid and innovative non-animal test methods Founded in 1997, IIVS is recognized as a leading provider of in vitro testing in support of toxicological safety evaluations. Rigorous scientific programs coupled with educational and outreach initiatives have established IIVS as a global leader in the advancement of alternatives to animal testing. For more information, visit http://www. .

Zhu F.-C.,Centers for Disease Control and Prevention | Hou L.-H.,Beijing Institute of Biotechnology | Li J.-X.,Centers for Disease Control and Prevention | Wu S.-P.,Beijing Institute of Biotechnology | And 16 more authors.
The Lancet | Year: 2015

Background Up to now, all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in 1976. We aimed to assess the safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine expressing the glycoprotein of the 2014 epidemic strain. Methods We did this randomised, double-blind, placebo-controlled, phase 1 clinical trial at one site in Taizhou County, Jiangsu Province, China. Healthy adults (aged 18-60 years) were sequentially enrolled and randomly assigned (2:1), by computer-generated block randomisation (block size of six), to receive placebo, low-dose adenovirus type-5 vector-based Ebola vaccine, or high-dose vaccine. Randomisation was pre-stratified by dose group. All participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was occurrence of solicited adverse reactions within 7 days of vaccination. The primary immunogenicity endpoints were glycoprotein-specific antibody titres and T-cell responses at day 28 after the vaccination. Analysis was by intention to treat. The study is registered with, number NCT02326194. Findings Between Dec 28, 2014, and Jan 9, 2015, 120 participants were enrolled and randomly assigned to receive placebo (n=40), low-dose vaccine (n=40), or high-dose vaccine. Participants were followed up for 28 days. Overall, 82 (68%) participants reported at least one solicited adverse reaction within 7 days of vaccination (n=19 in the placebo group vs n=27 in the low-dose group vs n=36 in the high-dose group; p=0·0002). The most common reaction was mild pain at the injection site, which was reported in eight (20%) participants in the placebo group, 14 (35%) participants in the low-dose group, and 29 (73%) participants in the high-dose vaccine group (p<0·0001). We recorded no statistical differences in other adverse reactions and laboratory tests across groups. Glycoprotein-specific antibody titres were significantly increased in participants in the low-dose and high-dose vaccine groups at both day 14 (geometric mean titre 421·4 [95% CI 249·7-711·3] and 820·5 [598·9-1124·0], respectively; p<0·0001) and day 28 (682·7 [424·3-1098·5] and 1305·7 [970·1-1757·2], respectively; p<0·0001). T-cell responses peaked at day 14 at a median of 465·0 spot-forming cells (IQR 180·0-1202·5) in participants in the low-dose group and 765·0 cells (400·0-1460·0) in those in the high-dose group. 21 (18%) participants had mild fever (n=9 in the placebo group, n=6 in the low-dose group, and n=6 in the high-dose group). No serious adverse events were recorded. Interpretation Our findings show that the high-dose vaccine is safe and robustly immunogenic. One shot of the high-dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days. Funding China National Science and Technology, Beijing Institute of Biotechnology, and Tianjin CanSino Biotechnology. © 2015 Elsevier Ltd.

Li J.-X.,Chongqing Medical University | Li J.-X.,Centers for Disease Control and Prevention | Mao Q.-Y.,National Institute for Food and Drug Control | Liang Z.-L.,National Institute for Food and Drug Control | And 2 more authors.
Expert Review of Vaccines | Year: 2014

The widespread epidemics of enterovirus 71 (EV71) seriously affected the Western Pacific Region. Young children, especially those younger than 3 years are the most susceptible population to the EV71-associated diseases. Several Asian countries have begun to focus on the research and development of EV71 vaccines. Five inactivated whole-virus EV71 candidate vaccines (three were manufactured in mainland China based on a C4 genotype strain, one in Taiwan based on a B4 genotype strain and one in Singapore based on a B2 genotype strain) have been assessed in clinical trials. Three candidate vaccines developed in mainland China have already completed Phase III clinical trials recently. The tested EV71 vaccine could provide good efficacy, satisfactory safety, and high immunogenicity. Thus, inactivated EV71 vaccines are expected to become the first available vaccines against EV71 in the near future. © 2014 Informa UK, Ltd.

Li L.,CAS Suzhou Institute of Nano Technology and Nano Bionics | Sun J.,CAS Suzhou Institute of Nano Technology and Nano Bionics | Li X.,CAS Suzhou Institute of Nano Technology and Nano Bionics | Zhang Y.,CAS Suzhou Institute of Nano Technology and Nano Bionics | And 4 more authors.
Biomaterials | Year: 2012

Silver nanoparticles (Ag NPs) are appealing due to their excellent antibacterial/antivirus properties. At the meantime, the wide applications of Ag NPs as antibacterial/antivirus agents arise the concern of Ag NPs' toxicity. However, quantitative understanding of the cytotoxicity of Ag NPs is minimum since that the Ag NPs in current studies have wide size distributions, in which the size effect of Ag NPs on cytotoxicity was unable to be accurately evaluated. In this work, unprecedentedly monodispersed Ag NPs with sizes of 25, 35, 45, 60 and 70 nm were obtained, respectively, by using an optimized polyol method with poly(vinyl pyrrolidone) (PVP) as surfactant. It was found that the reaction temperature, reaction time, concentration of the surfactant and reactants are playing important roles in determining the size and size distribution of Ag NPs. With the monodispersed Ag NPs as standard samples, the size- and dose- dependent cytotoxicity of Ag NPs against Human lung fibroblast (HLF) cells was accurately accomplished in terms of cell viability, apoptosis and necrosis, reactive oxygen species, etc. We expect that the monodispersed Ag NPs will act as the standard samples for quantitatively characterizing the toxicity of Ag NPs in vitro and in vivo. © 2011 Elsevier Ltd.

Shen S.,National Institute for Food and Drug Control | Shen S.,China National Institute for Nutrition and Food Safety | Yao J.,National Institute for Food and Drug Control | Shi Y.,National Institute for Food and Drug Control
Journal of Pharmaceutical and Biomedical Analysis | Year: 2014

This study assessed a general method of quantitative nuclear magnetic resonance (qNMR) for the calibration of atropine sulfate (Active Pharmaceutical Ingredient, API) as reference standard. The spectra were acquired in D2O using maleic acid as the internal standard. Conformational behaviors of tropane ring were observed and studied by means of NMR and ROESY experiments at different temperature, which showed that the azine methyl group was at equilibrium for axial and equatorial conformations at room temperature. Signal delay and monitor signals of qNMR experimentation were optimized for quantification. The study reported here validated the method's linearity, range, limit of quantification, stability and precision. The results were consistent with the results obtained from mass balance approach. © 2013 Elsevier B.V.

Zhang X.,National Institute for Food and Drug Control
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2014

The paper introduces supervision situation of enterprises of medical devices from the aspects of supervision team of medical devices, construction of credit system and implementation of regulation of quality management of medical devices, and raises supervision difficulties and puts forwards corresponding proposals.

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