Zobrazeno 1 - 10 of 21 pro vyhledávání: '"Michael McGuinness"'
1
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK
Autor: Phillip D. Kronstein, Jean Mulinde, Ni A. Khin, Seongeun-Julia Cho, Arindam Dasgupta, Cheryl Grandinetti, Gail Francis, Kassa Ayalew, Stephen Vinter, Jason Wakelin-Smith, Rachel Skeete, Bei Yu, Andrew Fisher, Paula Walker, Mandy Budwal-Jagait, Cynthia Kleppinger, Jennifer Martin, Michael McGuinness, Hayley Dixey
Publikováno v: Clinical Pharmacology & Therapeutics. 112:31-43
With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::745066f63e6896fb319ecf5978f3d83a
https://doi.org/10.1002/cpt.2386
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2
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
Autor: Andrew P Mayer, Jinhui Zhang, Sam Haidar, Sandra Nuti, Shyam Sarikonda, Therese Solstad, Megan McCausland, Fabian Junker, Elana Cherry, Susan M. Spitz, Tahseen Mirza, Anna Edmison, Patrick Faustino, Yan Zhang, Rafiq Islam, Steven Eck, Christèle Gonneau, Fabio Garofolo, Nilufer Tampal, Kevin Maher, Lisa Patti-Diaz, Kun Peng, Alberto Robert, Yow-Ming Wang, Rachel Palmer, Marcela Araya, Lakshmi Amaravadi, Alison Joyce, Daniela Verthelyi, Giane Sumner, Andrew Exley, Sally Fischer, Gustavo Mendes Lima Santos, Michael McGuinness, Yoshiro Saito, Alessandra Vitaliti, Naveen Dakappagari, Daniel Baltrukonis, Christina Satterwhite, Gregory Hopkins, Gregor Jordan, Akiko Ishii-Watabe, Arindam Dasgupta, David Lanham, Priscila Camillo Teixeira, Mitra Azadeh, Stephen Vinter, Sumit Kar, Lucia Zhang, Linda Terry, Michael Nathan Hedrick, João Pedras-Vasconcelos, Shabnam Tangri, Florian Neff, Natasha Savoie, Weili Yan, Matthew Andisik, Mohsen Rajabi Abhari, Richard Siggers, Lindsay King, Diaa Shakleya, Isabelle Cludts, Nisha Palackal, Meiyu Shen, Ulrike Sommer, Sylvie Bertholet, Susan Kirshner, Cherie Green, Christine Grimaldi, Susan Stojdl, Kristina McGuire, Vilma Decman, Jose Estevam, Suman Dandamudi, Seema Kumar, Richard Wnek, Catherine Soo, Haoheng Yan, Jan Welink, Rebecca Elliott, Abbas Bandukwala
Publikováno v: Bioanalysis. 13:295-361
The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract res
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e5706237408b458c58ed63921b541745
https://doi.org/10.4155/bio-2021-0005
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3
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)
Autor: Luca Ferrari, Wenkui Li, Christopher P. Evans, Lieve Dillen, Noah Post, Jens Sydor, Jinhui Zhang, Susan Stojdl, Boris Gorovits, Jason Boer, Anita Lee, Mark G. Qian, Natasha Savoie, Kevin P. Bateman, Brian Dean, Allena J. Ji, Jiang Wu, Amanda Wilson, Michael H. Buonarati, Jian Wang, Gustavo Mendes Lima Santos, Daniel S Spellman, Hendrik Neubert, Hui Zhang, Scott G. Summerfield, Eric Yang, Nilufer Tampal, Parya Nouri, Christopher J Beaver, Anna Edmison, Christine Fandozzi, Troy Voelker, Jenny Zhang, Fabio Garofolo, Michael McGuinness, Sam Haidar, Bill Mylott, Stephen Vinter, Arindam Dasgupta, Patrick Faustino, Daniela Fraier, Wenying Jian, Tahseen Mirza, Sune Sporring, Diaa Shakleya, Timothy V Olah, Eric Woolf, Stephen C. Alley, Nicola Hughes, Suman Dandamudi, Hongbin Yu, Phillip Sundman, Rebecca Elliott, Lina Luo, Jan Welink
Publikováno v: Bioanalysis. 13:203-238
The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15–29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract r
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::2d0f1046448eff2611c3c8337e268531
https://doi.org/10.4155/bio-2020-0324
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4
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (
Autor: Susan, Spitz, Yan, Zhang, Sally, Fischer, Kristina, McGuire, Ulrike, Sommer, Lakshmi, Amaravadi, Abbas, Bandukwala, Steven, Eck, Fabio, Garofolo, Rafiqul, Islam, Gregor, Jordan, Lindsay, King, Yoshiro, Saito, Giane, Sumner, Linda, Terry, Alessandra, Vitaliti, Yow-Ming, Wang, Christine, Grimaldi, Alison, Joyce, Rachel, Palmer, Matthew, Andisik, Marcela, Araya, Mitra, Azadeh, Daniel, Baltrukonis, Rebecca, Elliott, Sam, Haidar, Seema, Kumar, Andrew, Mayer, Florian, Neff, Nisha, Palackal, Kun, Peng, Mohsen Rajabi, Abhari, Christina, Satterwhite, Natasha, Savoie, Catherine, Soo, Stephen, Vinter, Jan, Welink, Weili, Yan, Kevin, Maher, David, Lanham, Sylvie, Bertholet, Naveen, Dakappagari, Christèle, Gonneau, Cherie, Green, Fabian, Junker, Sumit, Kar, Lisa, Patti-Diaz, Shyam, Sarikonda, Megan, McCausland, Priscila Camillo, Teixeira, Vilma, Decman, Jose, Estevam, Michael, Hedrick, Alberto Hidalgo, Robert, Gregory, Hopkins, Sandra, Nuti, Shabnam, Tangri, Richard, Wnek, Suman, Dandamudi, Arindam, Dasgupta, Anna, Edmison, Patrick, Faustino, Michael, McGuinness, Gustavo Mendes, Lima Santos, Tahseen, Mirza, Diaa, Shakleya, Susan, Stojdl, Nilufer, Tampal, Jinhui, Zhang, Elana, Cherry, Isabelle, Cludts, Andrew, Exley, Akiko, Ishii-Watabe, Susan, Kirshner, Joao, Pedras-Vasconcelos, Meiyu, Shen, Richard, Siggers, Therese, Solstad, Daniela, Verthelyi, Haoheng, Yan, Lucia, Zhang
Publikováno v: Bioanalysis. 13(5)
The 14
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::33bd3a6787b755dd13ebad7010c28d32
https://pubmed.ncbi.nlm.nih.gov/33511867
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7
Relationship of Physical Examination Findings and Self-Reported Symptom Severity and Physical Function in Patients With Degenerative Lumbar Conditions
Autor: Sarah Manes, Maura D. Iversen, Michael McGuinness, Sarah Ziaei, Mark A. Lyle
Publikováno v: Europe PubMed Central
Karolinska Institutet
Background and Purpose. Limited data are available to assist clinicians in clinical decision making. The purpose of this study was to examine the relationships of symptom provocation during physical examination (PE) procedures and self-report of symp
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96d31b50e517d6f45924d7e2b1584c40
https://doi.org/10.1093/ptj/85.2.120
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8
Changes in cytoplasmic calcium in endothelial cells and monocytes treated with estrogen (LB58)
Autor: Maia Love, Michael McGuinness, Ellen Cho, Doug Phelan, Maarij Baig
Publikováno v: The FASEB Journal. 28
Estrogen is a hormone which exerts its effects in different physiological processes including the initiation and progress of inflammation. In addition to nuclear receptors, estrogen binds to plasma membrane receptors and activates signal transduction
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e54b94b96d6a8db80496c5852b0554a7
https://doi.org/10.1096/fasebj.28.1_supplement.lb58
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