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在“Elsevier电子期刊”中，命中：556条，耗时：0.074971 秒

在所有数据库中总计命中：10,568条

1.The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage

作者：Michele Panzitta^a ; ^b ; ; Mauro Ponti^b ; ^e ; Giorgio Bruno^d ; ^f ; Giancarlo Cois^b ; ^g ; Alessandro D&rsquo ; Arpino^b ; ^h ; Paola Minghetti^d ; ⁱ ; Francesca Romana Mendicino^c ; Luana Perioli^a ; Maurizio Ricci^a ; ^b ; ^c ; ^{maurizio.ricci@unipg.it}

关键词：HTA ; Health Technology Assessment ; HSE ; Health Safety Environment ; GMP ; Good Manufacturing Practice ; EBM ; Evidence Based Medicine ; QS ; Quality System ; FP ; Finished Product ; QbD ; Quality By Design ; API ; Active Pharmaceutical Ingredient ; FTE ; PAT ; Process Analytical Technology ; MAH ; Marketing Authorization Holder

刊名：International Journal of Pharmaceutics

出版年：2017

2.Pre-clinical development of a hydrogen peroxide-inactivated West Nile virus vaccine

作者：Elizabeth A. Poore^a ; ¹ ; Dawn K. Slifka^a ; ¹ ; Hans-Peter Raué ; ^b ; Archana Thomas^b ; Erika Hammarlund^b ; Benjamin K. Quintel^a ; Lindsay L. Torrey^a ; Ariel M. Slifka^a ; Justin M. Richner^d ; Melissa E. Dubois^a ; Lawrence P. Johnson^c ; Michael S. Diamond^d ; ^e ; ^f ; ^g ; Mark K. Slifka^a ; ^b ; Ian J. Amanna^a ; ^{iamanna@najittech.com}

关键词：BDS ; bulk drug substance ; BPL ; β-propiolactone ; cGMP ; current good manufacturing practices ; DENV ; dengue virus ; DP ; drug product ; Env ; envelope protein ; FFA ; focus forming assay ; GLP ; good laboratory practices ; H2O2 ; hydrogen peroxide ; IVRP ; in vitro relative potency ; JEV ; Japanese encephalitis virus ; LOD ; limit of detection ; MAb ; monoclonal antibody ; MCB ; master cell bank ; MOI ; multiplicity of infection ; MVB ; master virus bank ; NT50 ; 50% neutralizing titer ; PFU ; plaque forming unit ; PPV ; porcin

刊名：Vaccine

出版年：2017

3.Food safety in cassava “flour houses” of Copioba Valley, Bahia, Brazil: Diagnosis and contribution to geographical indication

作者：Í ; caro Ribeiro Cazumbá ; da Silva^a ; ^g ; ^{icarocnn@ufba.br" class="auth_mail" title="E-mail the corresponding author} ; Ryzia de Cassia Vieira Cardoso^c ; ^f ; José ; Â ; ngelo Wenceslau Gó ; es^c ; ^f ; Janice Izabel Druzian^d ; ^g ; Permí ; nio Oliveira Vidal Jú ; nior^b ; ^f ; Alaane Caroline Benevides de Andrade^e ; ^f

关键词：Artisanal food ; Cassava flour ; Food hygiene ; Good manufacturing practices

刊名：Food Control

出版年：2017

4.Ex vivo encapsulation of dexamethasone sodium phosphate into human autologous erythrocytes using fully automated biomedical equipment

作者：Giovanni Mambrini^a ; ^{giovanni.mambrini@erydel.com} ; Marco Mandolini^a ; ^{marco.mandolini@erydel.com} ; Luigia Rossi^a ; ^b ; ^{luigia.rossi@uniurb.it} ; Francesca Pierigè ; ^b ; ^{francesca.pierige@uniurb.it} ; Giovanni Capogrossi^a ; ^{giovanni.capogrossi@erydel.com} ; Patricia Salvati^a ; ^{salvatipatricia@gmail.com} ; Sonja Serafini^a ; ^{sonja.serafini@erydel.com} ; Luca Benatti^a ; ^{luca.benatti@erydel.com} ; Mauro Magnani^a ; ^b ; ^{mauro.magnani@uniurb.it}

关键词：AT ; ataxia telangiectasia ; DSP ; dexamethasone sodium phosphate ; EDS ; EryDex system ; EDS-EP ; EDS end product ; GLP ; good laboratory practice ; GMP ; good manufacturing practice ; HCT ; hematocrit ; HD ; healthy donor ; HGB ; hemoglobin ; HPLC ; high-performance liquid chromatography ; HV ; healthy volunteer ; LLOQ ; lower limit of quantification ; MCH ; mean cellular hemoglobin ; MCHC ; mean cellular hemoglobin concentration ; MCV ; mean cellular volume ; MDD ; Medical Device Directive ; PhEur ; European Pharmacopoeia ; P

刊名：International Journal of Pharmaceutics

出版年：2017

5.Tracking Listeria monocytogenes contamination and virulence-associated characteristics in the ready-to-eat meat-based food products industry according to the hygiene level

作者：A.R. Henriques ; L.T. Gama ; M.J. Fraqueza ; ^{mjoaofraqueza@fmv.ulisboa.pt}

关键词：FSMS ; food safety management system ; GHMP ; good hygiene and manufacturing practices ; HACCP ; hazard analysis and critical control points ; RTE ; ready-to-eat food ; RTEMP ; ready-to-eat meat-based food products

刊名：International Journal of Food Microbiology

出版年：2017

6.Predictive Markers Guide Differentiation to Improve Graft Outcome in Clinical Translation of hESC-Based Therapy for Parkinson’s Disease

作者：Agnete Kirkeby¹ ; ² ; ³ ; ^{agnete.kirkeby@med.lu.se} ; Sara Nolbrant¹ ; ³ ; Katarina Tiklova⁴ ; Andreas Heuer¹ ; ³ ; Nigel Kee⁴ ; Tiago Cardoso¹ ; ³ ; Daniella Rylander Ottosson¹ ; ³ ; Mariah J. Lelos⁵ ; Pedro Rifes² ; ³ ; Stephen B. Dunnett⁵ ; Shane Grealish¹ ; ³ ; Thomas Perlmann⁴ ; Malin Parmar¹ ; ³ ; ⁶ ; ^{malin.parmar@med.lu.se}

关键词：Parkinson&rsquo ; s disease ; human embryonic stem cells ; hESCs ; dopaminergic neurons ; diencephalon ; transplantation ; subthalamic nucleus ; STN ; ventral midbrain ; VM ; midbrain-hindbrain boundary ; MHB ; FGF8 ; good manufacturing practice ; GMP

刊名：Cell Stem Cell

出版年：2017

7.A single, low dose of a cGMP recombinant BCG vaccine elicits protective T cell immunity against the human respiratory syncytial virus infection and prevents lung pathology in mice

作者：Pablo F. Cé ; spedes^a ; ¹ ; Emma Rey-Jurado^a ; ¹ ; Janyra A. Espinoza^a ; Claudia A. Rivera^a ; Gisela Canedo-Marroquí ; n^a ; Susan M. Bueno^a ; Alexis M. Kalergis^a ; ^b ; ^c ; ^{akalergis@bio.puc.cl}

关键词：BAL ; bronchoalveolar lavage ; BCG ; Bacillus Calmette et Guerin ; CFUs ; colony-forming units ; cGMP ; current Good Manufacturing Practices ; hRSV ; human respiratory syncytial virus ; FI-hRSV ; formalin-inactivated hRSV ; HI-hRSV ; heat-inactivated hRSV ; FACS ; fluorescence activated cell sorting

刊名：Vaccine

出版年：2017

8.No PERV transmission during a clinical trial of pig islet cell transplantation

作者：Vladimir A. Morozov^a ; Shaun Wynyard^b ; Shinichi Matsumoto^c ; Adrian Abalovich^d ; Joachim Denner^a ; ^{DennerJ@rki.de} ; Robert Elliott^e

关键词：AEC ; Animal Ethics Committee ; CA ; capsid ; COX ; cytochrome oxidase ; DOL ; Diatranz Otsuka Ltd ; ECL ; enhanced chemiluminescence ; GMP ; good manufacturing practice ; FeLV ; feline leukaemia virus ; HIV ; human immunodeficiency virus ; HRP ; horseradish peroxidase ; HTLV ; human T - cell leukaemia virus ; IEQ ; islet equivalents ; IgG ; immunoglobulin G ; kDa ; kilodalton ; LCT ; living cell technologies ; MTF CT ; MTF ; mammalian tissue free collagenase thermolysin ; NHP ; non-human primates ; NZ ; New Zealand ; PERV ; porci

刊名：Virus Research

出版年：2017

9.Application of quality by design in the current drug development

作者：Lan Zhang ; Shirui Mao ; ^{maoshirui@syphu.edu.cn}

关键词：Quality by design (QbD) ; Process analytical technology (PAT) ; Critical quality attributes (CQA) ; Design of experiment (DoE) ; Risk assessment ; Near infrared (NIR) spectroscopy

刊名：Asian Journal of Pharmaceutical Sciences

出版年：2017

10.Optimization of cGMP purification and expansion of umbilical cord blood-derived T-regulatory cells in support of first-in-human clinical trials

作者：David H. McKenna Jr.¹ ; ^{mcken020@umn.edu} ; Darin Sumstad¹ ; Diane M. Kadidlo¹ ; Bjorn Batdorf¹ ; Colin J. Lord² ; Sarah C. Merkel² ; Christine M. Koellner² ; Julie M. Curtsinger³ ; Carl H. June⁴ ; ⁵ ; James L. Riley⁵ ; ⁶ ; Bruce L. Levine⁴ ; ⁵ ; Jeffrey S. Miller³ ; Claudio G. Brunstein³ ; John E. Wagner² ; Bruce R. Blazar² ; Keli L. Hippen² ; ^{hippe002@umn.edu}

关键词：cGMP production ; graft versus host disease ; regulatory T cell

刊名：Cytotherapy

出版年：2017

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