{"id":1542,"date":"2021-02-01T15:13:57","date_gmt":"2021-02-01T07:13:57","guid":{"rendered":"http:\/\/www.tipr.com.cn\/wordpress\/?page_id=1542"},"modified":"2021-06-01T09:40:50","modified_gmt":"2021-06-01T01:40:50","slug":"fuwulingyu","status":"publish","type":"page","link":"https:\/\/en.tipr.com.cn\/index.php\/fuwulingyu\/","title":{"rendered":"\u670d\u52a1\u9886\u57df"},"content":{"rendered":"\t\t
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Drug Evaluation Service<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Tianjin Tiancheng drug assessment Co., Ltd (Drug assessment center of Tianjin institute of pharmaceutical research) originates from the pharmacology and Toxicology Laboratory of the former three state research institutions: Beijing institute of pharmaceutical industry, Tianjin institute of traditional Chinese medicine and Tianjin institute of pharmaceutical industry. It integrates three national technology platforms of innovative drug pharmacokinetic, pharmacodynamics and toxicology, and provides druggability research, preclinical pharmacology research, non-clinical safety evaluation and clinical pharmacokinetics research.<\/p>

The center undertakes the construction and operation tasks of State Key Laboratory of drug delivery technology and pharmacokinetics of Ministry of science and technology, Tianjin Key Laboratory of pharmacokinetics and pharmacodynamics, Tianjin new drug non-clinical evaluation technology engineering center, Tianjin biotechnology drug integrated service platform, Tianjin generic drug consistency evaluation comprehensive research center, etc., and participates in the national platform construction projects and new drug creation projects such as 1035 project, 863 plan, 973 Plan, and the national major special projects. We have served more than 300 enterprises, cooperated with nearly 50 research institutions, completed more than 1000 new drug R&D projects, and helped obtain more than 100 clinical trial approvals (including IND of FDA).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Professional Qualification<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Laboratory animal license<\/p>

The GLP certification of NMPA<\/p>

International AAALAC certification<\/p>

Radiation safety license<\/p>

Verification of bioanalytical capability of NIFDC (Biomacromolecule and small molecule)<\/p>

The qualification certificate of laboratory-to-laboratory comparison and examination for toxicity pathology detection<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Technical Team<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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More than 50% of research team with master degree or above<\/p>

The average working experience is 8.5 years<\/p>

14 toxicologists certified by CST<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Project Experience<\/strong><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Participates in the national platform construction projects and new drug creation projects such as 1035 project, 863 plan, 973 Plan, and the national major special projects.<\/p>

Served more than 300 enterprises, cooperated with nearly 50 research institutions, completed more than 1000 new drug R&D projects, and helped obtain more than 100 clinical trial approvals (including IND of FDA).<\/p>

In addition to drug evaluation, we also have the experience of the R&D services of products in various fields, such as medical devices, special medical food, health food, cosmetics and animal drugs.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Honor<\/strong><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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High tech Enterprises<\/p>

Excellent gazelle Enterprises<\/p>

Top 20 Chinese pharmaceutical outsourcing companies<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Secondary development service of Chinese materia medica<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Chinese materia medica\u00a0is the carrier of TCM theory, the main form of TCM clinical medication, and\u00a0the\u00a0important support for the development of TCM pharmaceutical industry.\u00a0Systematic secondary development can excavate the core value of listed Chinese materia medica,\u00a0focus on its clinical characteristics to increase curative effect,\u00a0and improve the safety, effectiveness and quality controllability of preparation products,\u00a0so as to promote the quality and efficiency of TCM\u00a0industry.<\/p>

Since 2006, under the leadership of academician Chang-xiao\u00a0Liu\u00a0and researcher \u00a0Tie-jun\u00a0Zhang, the TCM\u00a0R&D center of TIPR\u00a0has been committed to the secondary development of Chinese materia medica.\u00a0Through systematic research, the TCM\u00a0R&D center has\u00a0established an innovative model and a series of key technologies for the secondary development of Chinese materia medica, and applied them to:\u00a0(1) explanation of\u00a0the treatment principles, compatibility theory and compatibility rules of Chinese materia medica for diseases, so as to develop and improve the TCM theory; (2) clarification\u00a0of\u00a0the material basis and pharmacodynamic mechanism of complex Chinese medicine system\u00a0with\u00a0modern scientific methods, objective indicators and experimental evidence; (3) discovery\u00a0of\u00a0the functional characteristics and comparative advantages of Chinese\u00a0materia medica\u00a0in order to\u00a0excavate the\u00a0clinical core value, guide clinical practice, and improve clinical efficacy; (4)\u00a0establishment of\u00a0scientific and effective quality control methods to ensure uniform, stable and controllable drug quality.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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So far, research teams\u00a0of TCM\u00a0R&D center have\u00a0completed the secondary development of 14 Chinese patent medicines, including Shufeng Jiedu Capsules, Qingyan Dripping Pills, Maren Soft Capsules, Niuhuang Jiangya\u00a0Tablets, Bifeng\u00a0Jiangya\u00a0Tablets, Qianggan Capsules, Yuanhu Zhitong Dropping Pills, Liujing Toutong\u00a0Tablets, Danhong Huayu Oral Liquid, Haima\u00a0Bushen Pills”, Huoxue\u00a0Zhitong Capsules, Fufang Yuxingcao Heji, Naoxinqing\u00a0Tablets and Qingkailing Oral Liquid.\u00a0They have also made\u00a0the following remarkable research achievements: academic monographs of \u201cTCM Quality control-technology, method and demonstration\u201d, \u201cQuality standard improvement of Chinese patent medicine\u201d, \u201cTheory and practice of TCM quality markers\u201d, \u201cSecondary development of Yuanhu Zhitong Dropping Pills\u201d\u00a0and \u201cSecondary development\u00a0of Liujing Toutong Tablets\u201d\u00a0in Science Press; approximately\u00a0100 research papers,\u00a0including three\u00a0special issues of\u00a0Chinese Traditional and Herbal Drugs\u00a0and more than 10 articles in SCI\u00a0journals\u00a0were published.\u00a0At the same time,\u00a0more than 40 invention patents\u00a0were achieved.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Through secondary development, the clinical and market values\u00a0of related Chinese patent medicines were improved significantly. Taking Shufeng Jiedu Capsule as an example.\u00a0After systematic research, it was\u00a0listed as the recommended medication for 12 major diseases by the national health commission\u00a0and a category A species in the National Medical Insurance Catalogue\u00a0(2017). Shufeng Jiedu Capsule was also selected into the “Report on the Scientific and Technological Competitiveness of TCM Large Varieties (2019 Edition)” with a science and technology impact factor of 73.20, which ranks first in the national respiratory system medicine and the first in all types of Chinese medicine in the past three years. In addition, two\u00a0authorized invention patents were\u00a0obtained, and the improved\u00a0quality standard was\u00a0included in the Chinese Pharmacopoeia<\/i><\/em>\u00a0(2020 edition). Through secondary development, the clinical application of Shufeng Jiedu Capsules has been fully expanded, benefiting more than 50 million patients.\u00a0The products cover 29 provinces, cities, and autonomous regions, with annual sales increasing from 50 million to 600 million in 2019, which has achieved significant economic and social benefits.\u00a0The achievement named “Research on secondary development of Shufeng Jiedu Capsule” won the first prize of Anhui Science and Technology Progress Award in 2017.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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TCM\u00a0R&D center of TIPR is committed to providing continuous technical support for the development of Chinese medicine industry.\u00a0In the future, guided by clinical, corporate and market needs, we will continue to innovate research ideas and methods, and contribute to the value enhancement of more listed Chinese medicines and the sustainable development of Chinese medicine industry.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Clinical Research Services<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Tianjin Pharmaceutical Research Institute has a professional clinical project team and a perfect quality management system, which can provide phase I – IV clinical research and technical services for pharmaceutical enterprises, covering the solutions of the whole journey of drug R&D, such as project management, site management, audit, data management, biological sample detection, registration and medical support. We are customer-oriented to improve R&D quality, shorten R&D time Cycle and reduce R&D costs.<\/p>

We have good cooperative relationship with dozens of top-three hospitals in China, and have completed 20 BE trials. At present, the clinical trials of three innovative drugs are progressing steadily.<\/p>

Service Content<\/strong><\/p>

Clinical trial project management<\/p>

On site management of clinical trial institutions<\/p>

Training of clinical researchers<\/p>

Subject recruitment<\/p>

Third party audit<\/p>

Data management and statistical analysis<\/p>

Biological sample detection<\/p>

Registration and medical support<\/p>

Pharmacovigilance<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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To be the top R&D engine BigPharma in China
influencing the whole world<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Drug Evaluation Service Tianjin Tiancheng drug assessme […]<\/p>\n","protected":false},"author":4,"featured_media":3641,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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