作者：Heather L. Benz^a ; ^{heather.benz@fda.hhs.gov} ; Eugene F. Civillico^b ; ^{eugene.civillico@fda.hhs.gov}

关键词：ACMC ; Assessment of Capacity for Myoelectric Control ; BCI ; Brain-Computer Interface ; CDER ; Center for Drug Evaluation and Research ; CDRH ; Center for Devices and Radiological Health ; DARPA ; Defense Advanced Research Projects Agency ; EMG ; electromyogram ; HDE ; Humanitarian Device Exemption ; IDE ; Investigational Device Exemption ; MDIC ; Medical Device Innovation Consortium ; NHP ; Nottingham Health Profile ; PMA ; Premarket Approval ; PRO ; patient-reported outcome ; PSFS ; Patient-Specific Functional Scale

刊名：Experimental Neurology

出版年：2017

作者：Icilio Cavero^a ; ^{iciliocavero@outlook.com} ; Henry Holzgrefe^b

关键词：α2M ; alpha2-macroglobuline ; ARMD ; age-related macular degeneration ; AMP ; adenosine monophosphate ; ATP ; adenosine triphosphate ; ASR ; acoustic startle response ; BM ; basilar membrane ; cAMP ; cyclic adenosine monophosphate ; CBER ; Center for Biologics Evaluation and Research ; CCCRC ; Connecticut chemosensory clinical research center ; CIPN ; chemotherapy-induced peripheral neurotoxicity ; CSERP ; chemosensory event-related potentials ; CRO ; contract research organizations ; CSF ; cerebrospinal fluid ; DN4 ; dou

刊名：Journal of Pharmacological and Toxicological Methods

出版年：2017

作者：Rajneet Kaur Khurana^a ; Arvind K. Bansal^b ; Sarwar Beg^a ; Andrea Julie Burrow^c ; O.P. Katare^a ; Kamalinder K. Singh^c ; Bhupinder Singh^a ; ^d ; ^{bsbhoop@yahoo.com} ; ^{bsbhoop@pu.ac.in}

关键词：QbD ; Antioxidants ; Phytomolecule ; Molecular docking ; P-gp efflux ; Caco-2 bidirectional permeability assay ; SPIP

刊名：International Journal of Pharmaceutics

出版年：2017

作者：Manuel Ibarra ; PhD ; Marta Vá ; zquez ; PhD ; Pietro Fagiolino ; PhD ; ^{pfagioli@fq.edu.uy}

关键词：sex-by-formulation interaction ; bioequivalence ; bioavailability ; intrasubject variability ; multisource drug products

刊名：Clinical Therapeutics

出版年：2017

作者：Mary J. Kao ; MD ; Hector Nunez ; BS ; Sean F. Monaghan ; MD ; Daithi S. Heffernan ; MD ; Charles A. Adams Jr. ; MD ; Stephanie N. Lueckel ; MD ; Andrew H. Stephen ; MD ; ^{andrew_stephen@brown.edu}

关键词：Delayed presentation ; Elderly ; Trauma ; Injury ; Withdrawal

刊名：Journal of Surgical Research

出版年：2017

作者：Adam C. Fisher^a ; Sau L. Lee^a ; ^{sau.lee@fda.hhs.gov} ; Daniel P. Harris^a ; Lucinda Buhse^a ; Steven Kozlowski^a ; Lawrence Yu^a ; Michael Kopcha^a ; Janet Woodcock^b

关键词：ADF ; abuse deterrent formulation ; API ; active pharmaceutical ingredient ; T-DM1 ; Ado-Trastuzumab Emtansine ; ADC ; antibody-drug conjugate ; CDER ; center for drug evaluation and research ; CBRN/EID ; chemical ; biological ; radiological/nuclear and emerging infectious disease ; CMC ; chemistry ; manufacturing ; and controls ; DMD ; Duchenne muscular dystrophy ; DLS ; dynamic light scattering ; FDA ; food and drug administration ; FTIR ; Fourier transform infrared spectroscopy ; GA ; glatiramer acetate ; IVIVC ; in vivo

刊名：International Journal of Pharmaceutics

出版年：2016

作者：Mike Celone^a ; Bobbie Person^b ; ^{bobbieperson@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Said M. Ali^c ; Jameelat H. Lyimo^a ; Ulfat A. Mohammed^a ; Alippo N. Khamis^a ; Yussra S. Mohammed^c ; Khalfan A. Mohammed^a ; David Rollinson^d ; Stefanie Knopp^d ; ^e ; ^f

关键词：EKBB ; Ethikkommission beider Basel ; HCD ; Human Centered Design ; HIV ; Human Immunodeficiency Virus ; MDA ; mass drug administration ; NCEZID ; National Center for Emerging Zoonotic Diseases ; SCORE ; Schistosomiasis Consortium for Operational Research and Evaluation ; ZAMREC ; Zanzibar Medical Research Ethics Committee ; ZEST ; Zanzibar Elimination of Schistosomiasis Transmission

刊名：Acta Tropica

出版年：2016

作者：Uwe Siebert¹ ; ² ; ³ ; ⁴ ; ^{public-health@umit.at" class="auth_mail" title="E-mail the corresponding author} ; ^{usiebert@hsph.harvard.edu" class="auth_mail" title="E-mail the corresponding author} ; Beate Jahn¹ ; Ursula Rochau¹ ; ² ; Petra Schnell-Inderst¹ ; ² ; Agnes Kisser⁵ ; Theresa Hunger¹ ; ² ; Gaby Sroczynski¹ ; ² ; Nikolai Mü ; hlberger¹ ; ² ; Wolfgang Willenbacher⁶ ; Simon Schnaiter⁷ ; Gottfried Endel⁸ ; Lukas Huber⁹ ; ¹⁰ ; Guenther Gastl⁶ ; on behalf of the Oncotyrol HTA & Outcomes Research Working Group^a

关键词：Personalized medicine ; research cooperation ; translation ; health technology assessment ; outcomes research ; cancer

刊名：Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen

出版年：2015

作者：Priya S. Kishnani^a ; ^{priya.kishnani@duke.edu" class="auth_mail" title="E-mail the corresponding author} ; Patricia I. Dickson^b ; ^{pdickson@labiomed.org" class="auth_mail" title="E-mail the corresponding author} ; Laurie Muldowney^c ; ^{laurie.muldowney@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Jessica J. Lee^c ; ^{jessica.j.lee@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Amy Rosenberg^d ; ^{amy.rosenberg@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Rekha Abichandani^e ; ^{rabichan@shire.com" class="auth_mail" title="E-mail the corresponding author} ; Jeffrey A. Bluestone^f ; ^{jeff.bluestone@ucsf.edu" class="auth_mail" title="E-mail the corresponding author} ; Barbara K. Burton^g ; ^{bburton@luriechildrens.org" class="auth_mail" title="E-mail the corresponding author} ; Maureen Dewey^c ; ^{maureen.dewey@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Alexandra Freitas^h ; ^{afreitas@rarediseases.org" class="auth_mail" title="E-mail the corresponding author} ; Derek Gavin^h ; ^{dgavin@rarediseases.org" class="auth_mail" title="E-mail the corresponding author} ; Donna Griebel^c ; ^{donna.griebel@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Melissa Hoganⁱ ; ^{melissa@savingcase.com" class="auth_mail" title="E-mail the corresponding author} ; Stephen Holland^j ; ^{steve.holland@thomsonreuters.com" class="auth_mail" title="E-mail the corresponding author} ; Pranoot Tanpaiboon^k ; ^{ptanpaib@childrensnational.org" class="auth_mail" title="E-mail the corresponding author} ; Laurence A. Turka^l ; ^{lturka@partners.org" class="auth_mail" title="E-mail the corresponding author} ; Jeanine J. Utz^m ; ^{utz002@umn.edu" class="auth_mail" title="E-mail the corresponding author} ; Yow-Ming Wangⁿ ; ^{yowming.wang@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; Chester B. Whitley^m ; ^{whitley@umn.edu" class="auth_mail" title="E-mail the corresponding author} ; Zoheb B. Kazi^a ; ^{zoheb.kazi@dm.duke.edu" class="auth_mail" title="E-mail the corresponding author} ; Anne R. Pariser^o ; ^{anne.pariser@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author}

关键词：Ab ; antibody ; ADAs ; anti-drug antibodies ; Ag ; antigen ; BiPAP ; bilevel positive airway pressure ; CDER ; Center for Drug Evaluation and Research ; CNS ; central nervous system ; CRIM ; cross-reactive immunologic material ; DGIEP ; Division of Gastroenterology and Inborn Errors of Metabolism ; ERT ; enzyme replacement therapy ; FcR ; Fc receptor ; FDA ; Food and Drug Administration ; GAA ; acid alpha glucosidase ; GAG ; glycosaminoglycans ; HLA ; human leukocyte antigen ; HSAT ; high and sustained anti-rhGAA IgG antibo

刊名：Molecular Genetics and Metabolism

出版年：2016

作者：Yin Leng Kua^a ; Suyin Gan^a ; ^{suyin.gan@nottingham.edu.my" class="auth_mail" title="E-mail the corresponding author} ; Andrew Morris^b ; Hoon Kiat Ng^c

关键词：AOAC ; Association of Official Agricultural Chemists ; AOCS ; American Oil Chemists&rsquo ; Society ; C30 ; triacontyl ; CDER ; Center for Drug Evaluation and Research ; CPO ; crude palm oil ; GC ; gas chromatography ; HPLC ; high ; performance liquid chromatography ; ICH ; The International Conference on Harmonization ; LOD ; limit of detection ; LOQ ; limit of quantification ; OH ; hydroxyl ; PFP ; pentafluorophenyl ; PTFE ; polytetrafluoroethylene ; R2 ; coefficient of determination ; RPO ; refined palm oil ; RSD ; relative

刊名：Journal of Food Composition and Analysis

出版年：2016