Chinese Journal of New Drugs 2014 Issue 8 bian zhe tui jian

..............page:850

juan shou yu

..............page:852

WINDOW OF NEW DRUGS
ben kan ;

..............page:853-854

International Pharmacovigilance Flash
ben kan ;

..............page:855-856

Philosophy of cooperation in clinical trials for pediatric drugs in the United States and its inspirations on China
CHEN Yong-fa;SHI Ying;School of International Pharmaceutical Business;China Pharmaceutical University;

..............page:857-860+884

Evaluation of technological innovation capability in the pharmaceutical industry in the eastern China
CHU Shu-zhen;ZHANG Su-rong;School of International Pharmaceutical Business;China Pharmaceutical University;

..............page:861-864+878

Translational medicine: solution to increase R&D productivity
Frank Jiang;Sanofi Asia-Pacific R&D Center;

..............page:865-870

Clinical trial status and trends from quality management perspective
LI Qing-hong;CHEN Jing;ZHANG Ping;ZHOU Li-ping;Pfizer Research and Development Center;Streamline MedTech Co.;Ltd.;Global Development Beijing;Bayer Health Care;Ltd.;

..............page:871-878

Current status and trend of clinical data management at electronization time
DENG Ya-zhong;YU Jia;LIU Chuan;LIU Zong-fan;Covance Pharmaceutical Research and Development Co.;Ltd.;Medidata Solutions Worldwide;Merck Sharp & Dohme China Ltd;

..............page:879-884

Considerations on project management of clinical trials in China
FANG Fang;Edwards LifeScience;LLC.;

..............page:885-888+895

Statistical methods for clinical trials in oncology
YIN Yue;ZHANG Hui;QU Peng;Roche Holding Ltd.;Pfizer Research Development Co.;Ltd.;

..............page:889-895

Research and analysis of CMC requirements for generic PEGylated liposomal doxorubicin
ZHANG Ning;Center for Drug Evaluation;China Food and Drug Administration;

..............page:896-900+911

The structural characterization of low molecular weight heparin
ZHANG Zhen;Center for Drug Evaluation;China Food and Drug Administration;

..............page:901-905+939

Comments on the development and assessment of the drug impurities and substances related to recombinant monoclonal antibodies
WEI Wei;LUO Jian-hui;YIN Hong-zhang;XIANG Jin-zhong;Center for Drug Evaluation;China Food and Drug Administration;

..............page:906-911

Overview of the vaccine quality and regulation requirements in China
GAO En-ming;LI Min;YIN Hong-zhang;LUO Jian-hui;Center for Drug Evaluation;China Food and Drug Administration;

..............page:912-914

Theory and methodology of enrichment strategies and its application in new drug development
YANG Zhi-min;LI Ning;GAO Chen-yan;CHEN Xiao-yuan;ZHANG Jie;Center for Drug Evaluation;China Food and Drug Administration;Sanofi Asia-Pacific R&D Center;

..............page:915-920+947

Application of “quality by design” in the formulation and process research of generic injections
JIANG Yu;YANG Jian-hong;WANG Ya-min;Center for Drug Evaluation;China Food and Drug Administration;

..............page:921-924+954

Technical requirements and related guidelines of the nanodrugs in FDA and EMA
HE Wu;YANG Jian-hong;WANG Hai-xue;LI Xue-ming;Center for Drug Evaluation;China Food and Drug Administration;School of Pharmaceutical Sciences;Nanjing Tech University;

..............page:925-931

Key points of the changes of FDA guidance on BA /BE studies in INDs /NDAs
LI Li;ZHANG Yu-hu;Center for Drug Evaluation;China Food and Drug Administration;

..............page:932-935

Interpretation of the summary sheet of main research information in the form CTD(drug substance)
KANG Jian-lei;HE Wu;XU Zhen-yu;LI Xue-mei;Center for Drug Evaluation;China Food and Drug Administration;

..............page:936-939

Interpretation of the guideline of compatibility study of pharmaceutical products and packaging materials——the assessment of experimental data
MA Yu-nan;MA Lei;JIANG Yu;Center for Drug Evaluation;China Food and Drug Administration;

..............page:940-943

Discussion of key issues on the origin change of APIs used in pharmaceutical preparations
SHI Ji-feng;WANG Ya-min;LIU Lu;Center for Drug Evaluation;China Food and Drug Administration;

..............page:944-947

A new concept of pharmaceutical management system: quality-by-design(QbD)
WANG Ming-juan;HU Xiao-ru;DAI Zhong;MA Shuang-cheng;National Institutes for Food and Drug control;

..............page:948-954

Targeting B-RAF mutation for cancer therapy
YUAN Xi;DU Rong;WEI Jing;WEI Min;LUO Lü-song;BeiGene Co.;Ltd.;

..............page:955-961

Viral clearance requirement for cell-line derived biologics at different stages of development
CHEN Qi;ZHANG Min;YANG Bin;Philip Lester;Purification Development;Genentech;Inc.;South San Francisco;

..............page:962-967

Safety of Xueshuantong injection in patients with acute coronary syndrome
WANG Xin-gang;LI Jian-ping;HUO Yong;Department of Cardiology;The First Hospital Affiliated Peking University;

..............page:968-971+976

Efficacy and safety of paliperidonepalmitate injection in the treatment of schizophrenia in teenagers
MA Jun;LI Yi-chen;XU Han-ming;ZENG Hong-ling;XIE Jun;LEI Yu;SUN Ke;SONG Jia;LI Jin-guang;The Affiliated Hospital of Tongji Medical School of Huazhong Science and Technology University;Wuhan Mental and Health Center;

..............page:972-976

China Biological Products Annual Conference

..............page:978