نتائج البحث - "Afshin Safavi"

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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

المؤلفون: Steven Piccoli, Devangi Mehta, Alessandra Vitaliti, John Allinson, Shashi Amur, Steve Eck, Cherie Green, Michael Hedrick, Shirley Hopper, Allena Ji, Alison Joyce, Virginia Litwin, Kevin Maher, Joel Mathews, Kun Peng, Afshin Safavi, Yow-Ming Wang, Yan Zhang, Lakshmi Amaravadi, Nisha Palackal, Sai Thankamony, Chris Beaver, Eris Bame, Thomas Emrich, Christine Grimaldi, Jonathan Haulenbeek, Vellalore Kakkanaiah, David Lanham, Andrew Mayer, Paul C Trampont, Laurent Vermet, Naveen Dakappagari, Catherine Fleener, Fabio Garofolo, Cynthia Rogers, Shabnam Tangri, Yuanxin Xu, Meina Liang, Manoj Rajadhyaksha, Susan Richards, Becky Schweighardt, Shobha Purushothama, Daniel Baltrukonis, Jochen Brumm, Elana Cherry, Jason Delcarpini, Carol Gleason, Susan Kirshner, Robert Kubiak, Luying Pan, Michael Partridge, João Pedras-Vasconcelos, Qiang Qu, Venke Skibeli, Therese Solstad Saunders, Roland F Staack, Kay Stubenrauch, Al Torri, Daniela Verthelyi, Haoheng Yan, Boris Gorovits, Rachel Palmer, Mark Milton, Brian Long, Bart Corsaro, Vahid Farrokhi, Michele Fiscella, Neil Henderson, Vibha Jawa, Jim McNally, Rocio Murphy, Hanspeter Waldner, Tong-Yuan Yang

المصدر: Bioanalysis. 11:2207-2244

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::1d81a589202e4c0b3c30c4ddc1d93790
https://doi.org/10.4155/bio-2019-0271

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The business of bioanalysis: new technology integration into bioanalytical workflows

المؤلفون: Scott G. Summerfield, Dominic Warrino, Meina Liang, Lina Luo, Afshin Safavi, Ian Moore, Roger Hayes

المصدر: Bioanalysis. 10:1775-1779

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e0bbc470bf4871a1090573fc65a31d55
https://doi.org/10.4155/bio-2018-0269

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The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud

المؤلفون: Andrea Wakefield, Barry van der Strate, Elizabeth Groeber, Saadya Fatmi, Jing Tu, John Allinson, Yansheng Liu, Hanna Ritzén, John Kamerud, Maria Cruz Caturla, Phyllis Conliffe, Zhongping John Lin, Rafiq Islam, Kayode Awaiye, Chad Briscoe, Jenny Lin, Javier Torres, James Hulse, Jim Yamashita, Shane Karnik, Anahita Keyhani, Simona Rizea Savu, Yinghe Li, Nicola Hughes, Rabab Tayyem, Patrick Bennett, Mike Buonarati, Laura Cojocaru, Wei Garofolo, Steve Lowes, Prashant Kale, Afshin Safavi, Dominic Warrino, Mohammed Bouhajib, Paul Rhyne, Michele Malone, Stephanie Mowery, Bruce Stouffer, Mathilde Yu, Daniel Tang, Masood Khan, Ira DuBey, Neil Adcock, Nadine Boudreau, Radha Shekar, Ardeshir Khadang, Edward O'Connor, Christina Satterwhite, Edward Tabler, Philippe Couerbe, Ron Shoup, Adriana Iordachescu, Jennifer Zimmer, Eric Thomas, Natasha Savoie, Jenifer Vija, Rhonda Johnson, Stephanie Cape, Clark V. Williard, Christina Sanchez, Kai Kurylak, Chris Beaver, Corey Nehls, James Bourdage, Mohamed Osman, Brent Matthews, Roger Hayes, Luigi Silvestro, Michele Fiscella

المصدر: Bioanalysis. 9:505-516

مصطلحات موضوعية: Research Report, Bioanalysis, Computer science, Clinical Biochemistry, Stability (learning theory), Guidelines as Topic, Sample (statistics), Bioinformatics, 030226 pharmacology & pharmacy, 01 natural sciences, Chemistry Techniques, Analytical, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, Drug Stability, Acceptance testing, Data integrity, Humans, General Pharmacology, Toxicology and Pharmaceutics, Notice, Data Collection, Matrix stability, 010401 analytical chemistry, General Medicine, Sample stability, 0104 chemical sciences, Medical Laboratory Technology, Engineering management, Pharmaceutical Preparations, Government Regulation, Biomarkers

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1dd221211c9c17d74f26ad79eddd99f3
https://doi.org/10.4155/bio-2017-5000

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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)

المؤلفون: Akiko Ishii-Watabe, Albert Torri, Rong Zeng, Daniel Kramer, Steven P. Piccoli, David J. Uhlinger, Stephanie Fraser, Patricia Siguenza, Afshin Safavi, John Smeraglia, Apollon Papadimitriou, Yan G. Ni, Susan M. Richards, Kyra J. Cowan, Alessandra Vitaliti, Lakshmi Amaravadi, Boris Gorovits, Gustavo Mendes Lima Santos, John Kadavil, Sam Haidar, Jan Welink, Yongchang Qiu, João Pedras-Vasconcelos, Chan C. Whiting, Li Xue, Christina Satterwhite, John Kamerud, Swati Gupta, Natasha Savoie, Herbert Birnboeck, Yoshiro Saito, Paul Rhyne, Fabrizio Galliccia, Laurent Cocea, Stephanie Croft, Bonnie Wu, Theingi M. Thway, Virginia Litwin, Corinna Krinos-Fiorotti, Darshana Jani, Charles S Hottenstein, Vinita Gupta, Roland F Staack, Fabio Garofolo, Eginhard Schick, Kara Scheibner, Meena Subramanyam, John Allinson, Renuka Pillutla, Robert Nelson, Flora Berisha, Martin Ullmann, Giane Sumner

المصدر: Bioanalysis. 8:2475-2496

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9a67282718390ee4d7f9eb9599bdcf67
https://doi.org/10.4155/bio-2016-4989

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9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks

المؤلفون: Ardeshir Khadang, Elizabeth Groeber, Gunjan Soni, Yi Qun Xiao, Afshin Safavi, Saadya Fatmi, Manon Verville, Daniel Mulvana, Gene Ray, Sarah Harris, Mathilde Yu, Allan Xu, Jenny Lin, Isabelle Dumont, Clare Kingsley, Mike Buonarati, Nico C van de Merbel, Masood Khan, Natasha Savoie, Ian Ward, Luigi Silvestro, Michele Fiscella, Nadine Boudreau, Curtis Sheldon, Jaap Wieling, Richard LeLacheur, Christina Satterwhite, Benno Ingelse, Anahita Keyhani, Shane Karnik, Kai Kurylak, Ann Lévesque, Roger Hayes, Bob Nicholson, Rafiq Islam, Mike Allen, Jennifer Zimmer, Edward Tabler, Philippe Couerbe, Colin Pattison, Xinping Fang, Lorella Di Donato, Zhongping John Lin, Mario Rocci, Manju Saxena, Yansheng Liu, Ron Shoup, Patrick Bennett, Wei Garofolo, Laura Cojocaru, Stephanie Cape, Maria Cruz Caturla, Nicola Hughes, Jennifer Bravo, James Bourdage, Michele Malone, Chad Briscoe, James Hulse, Hanna Ritzén, Mohammed Bouhajib

المصدر: Bioanalysis. 8:487-495

مصطلحات موضوعية: Bioanalysis, Medical education, Best practice, 010401 analytical chemistry, Clinical Biochemistry, Biosimilar, General Medicine, Audit, Bioinformatics, 030226 pharmacology & pharmacy, 01 natural sciences, 0104 chemical sciences, Analytical Chemistry, 03 medical and health sciences, Medical Laboratory Technology, 0302 clinical medicine, Business, General Pharmacology, Toxicology and Pharmaceutics

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::7a683b7b6ce604e8c46e74aad1120a5d
https://doi.org/10.4155/bio.16.16

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Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves

المؤلفون: Jeffrey Sailstad, Mitra Azadeh, Stephen MacMannis, Boris Gorovits, Perceval Sondag, John Kamerud, Afshin Safavi

المصدر: The AAPS Journal. 20

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a2cddfdd66bdead69f63809b393b5cc4
https://doi.org/10.1208/s12248-017-0159-4

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2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelinesbiomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays)

المؤلفون: Pekka Kurki, Robert Neely, Akiko Ishii-Watabe, Soma Ray, Yanhua Zhang, Giane Sumner, Susan M. Richards, Lorella Di Donato, Roland F Staack, Charles S Hottenstein, Seongeun Julia Cho, Saloumeh K Fischer, Lauren Stevenson, Jim McNally, Jonathan Haulenbeek, Lilian Yengi, John Smeraglia, Boris Gorovits, Yuanxin Xu, Jenny Hu, Joe Bower, Ashley Mullan, Yan Zhang, Rafiq Islam, Daniel Kramer, Tong-Yuan Yang, John Kadavil, Flora Berisha, Barry van der Strate, Linglong Zou, Laurent Cocea, Kay-Gunnar Stubenrauch, Gerry Kolaitis, Renuka Pillutla, Lakshmi Amaravadi, Thorsten Verch, Chris Beaver, John Kamerud, Marianne Scheel Fjording, Fabio Garofolo, Xuemei Zhao, Yoshiro Saito, Shashi Amur, An Song, Stephen J. Zoog, Kara Scheibner, João Pedras-Vasconcelos, Natasha Savoie, Sam Haidar, Bruce Stouffer, Isabelle Cludts, Binodh DeSilva, Jianing Zeng, Montserrat Carrasco-Triguero, Afshin Safavi, Apollon Papadimitriou, Darshana Jani, Isabella Berger, Michael A Partridge, Jan Welink, Shalini Gupta, Devangi Mehta, Stephen MacMannis, Herbert Birnboeck, Nilufer Tampal, Steven P. Piccoli, Stephanie Fraser

المصدر: Bioanalysis. 9(24)

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::62bf96cba6584d17b853103a8dbb1b10
https://pubmed.ncbi.nlm.nih.gov/29205064

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Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

المؤلفون: Robert Nicholson, Douglas M. Fast, Saadya Fatmi, Suzanne Martinez, Masood Khan, Dan Mamelak, Pilar Gonzalez, Zhongping John Lin, William Nowatzke, Laura Wright, John Kamerud, Richard LeLacheur, Daniel Tang, Afshin Safavi, Rafiq Islam, Ray Steffen, Ann Levesque, Jake Harman, Roger Hayes, Shane Karnik, Douglas J Turk, Michele Malone, Steve Lowes, Mohammed Bouhajib, Sofi Gagnon-Carignan, Ronald Shoup, Kayode Awaiye, Jennifer Zimmer, John Allinson, Maria Cruz Caturla, Yansheng Liu, Mark Warren, Jenny Lin, Allan Xu, Scott Reuschel, Wei Garofolo, Xinping Fang, Jenifer Vija, James Petrilla, Laura Cojocaru, Marie Rock, Isabelle Dumont, Curtis Sheldon, Dominique Gouty, Andrew Dinan, Yasuhiro Yamashita

المصدر: Bioanalysis. 4:2335-2342

مصطلحات موضوعية: Bioanalysis, business.industry, education, Clinical Biochemistry, Accounting, Drugs stability, Nanotechnology, Biosimilar, General Medicine, Guideline, Analytical Chemistry, Medical Laboratory Technology, Biomarker (medicine), Business, General Pharmacology, Toxicology and Pharmaceutics, Drug industry, Reference standards

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::cc93f9eed5ee8f578fa4dc829825949d
https://doi.org/10.4155/bio.12.213

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2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity)

المؤلفون: Daniel T. Mytych, Stephanie Fraser, Andre Nogueira da Costa, An Song, Michael Skelly, Susan Kirshner, John Smeraglia, Alyssa Morimoto, Soma Ray, Jeffrey Spond, Boris Gorovits, Corinna Krinos-Fiorotti, Natasha Savoie, Laura Salazar-Fontana, Afshin Safavi, Theingi M. Thway, Mark Ma, John Kamerud, Apollon Papadimitriou, Noriko Katori, Tong-Yuan Yang, Roland F Staack, Shannon D Chilewski, Herbert Birnboeck, Nilufer Tampal, Jad Zoghbi, Clare Kingsley, John Allinson, Marianne Scheel Fjording, Troy E. Barger, Renuka Pillutla, Rafiq Islam, Birgit Jaitner, Jan Welink, Sam Haidar, Susan M. Richards, Judy Shih, Martin Schaefer, Jim McNally, David Lanham, Viswanath Devanarayan, Bruce Stouffer, Shalini Gupta, Heather Myler, Linlin Luo, Yan G. Ni, Albert Torri, Lakshmi Amaravadi, Fabio Garofolo

المصدر: Bioanalysis. 7(24)

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cf50ee85b134fbd0f31c6a61fc60f4a5
https://pubmed.ncbi.nlm.nih.gov/26635247

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Degradation of Dynorphin-Related Peptides by the Puromycin-Sensitive Aminopeptidase and Aminopeptidase M

المؤلفون: Louis B. Hersh, Afshin Safavi

المصدر: Journal of Neurochemistry. 65:389-395

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4e119948c49cd0031df009abb011eace
https://doi.org/10.1046/j.1471-4159.1995.65010389.x

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