نتائج البحث - "Corey Nehls"

1

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

المؤلفون: Brian Booth, Lauren Stevenson, Renuka Pillutla, Michael Buonarati, Chris Beaver, Daniela Fraier, Fabio Garofolo, Sam Haidar, Rafiq Islam, Christopher James, John Kadavil, Olga Kavetska, Fumin Li, Christina Satterwhite, Natasha Savoie, Sriram Subramaniam, Nilufer Tampal, Theingi Thway, Eric Woolf, Olivier Le Blaye, Matthew Andisik, Chad Briscoe, Stephanie Cape, Arindam Dasgupta, Sally Fischer, Roger Hayes, John Kamerud, Gustavo Mendes Lima Santos, Corey Nehls, Catherine Soo, Stephen Vinter, Emma Whale, Keyang Xu, Seongeun (Julia) Cho, Anna Edmison, Sean Kassim, Thais Correa Rocha, Jan Welink, Shashi Amur, Abbas Bandukwala, Elana Cherry, Shirley Hopper, Akiko Ishii-Watabe, Susan Kirshner, Kevin Maher, Joao Pedras-Vasconcelos, Yoshiro Saito, Therese Solstad Saunders, Venke Skibeli, Daniela Verthelyi, Yow-Ming Wang, Haoheng Yan

المصدر: Bioanalysis. 11:2099-2132

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::11defcffa0808309e5eab2a4c0f960bb
https://doi.org/10.4155/bio-2019-0270

PDF full text from Publisher

Find this article in full text from ProQuest

2

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (

المؤلفون: Brian, Booth, Lauren, Stevenson, Renuka, Pillutla, Michael, Buonarati, Chris, Beaver, Daniela, Fraier, Fabio, Garofolo, Sam, Haidar, Rafiq, Islam, Christopher, James, John, Kadavil, Olga, Kavetska, Fumin, Li, Christina, Satterwhite, Natasha, Savoie, Sriram, Subramaniam, Nilufer, Tampal, Theingi, Thway, Eric, Woolf, Olivier Le, Blaye, Matthew, Andisik, Chad, Briscoe, Stephanie, Cape, Arindam, Dasgupta, Sally, Fischer, Roger, Hayes, John, Kamerud, Gustavo Mendes, Lima Santos, Corey, Nehls, Catherine, Soo, Stephen, Vinter, Emma, Whale, Keyang, Xu, Seongeun Julia, Cho, Anna, Edmison, Sean, Kassim, Thais Correa, Rocha, Jan, Welink, Shashi, Amur, Abbas, Bandukwala, Elana, Cherry, Shirley, Hopper, Akiko, Ishii-Watabe, Susan, Kirshner, Kevin, Maher, Joao, Pedras-Vasconcelos, Yoshiro, Saito, Therese Solstad, Saunders, Venke, Skibeli, Daniela, Verthelyi, Yow-Ming, Wang, Haoheng, Yan

المصدر: Bioanalysis. 11(23)

مصطلحات موضوعية: Research Report, United States Food and Drug Administration, Humans, Biological Assay, Guidelines as Topic, Immunogenetic Phenomena, Biomarkers, United States

URL الوصول: https://explore.openaire.eu/search/publication?articleId=pmid________::4eaf9248d86cd2b05eb13fd4e2a0620d
https://pubmed.ncbi.nlm.nih.gov/31833782

PDF full text from Publisher

Find this article in full text from ProQuest

3

GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline

المؤلفون: Xinping Fang, Cheikh Kane, Valentine Barra, Dawn Dufield, Marsha Luna, Adriane Spytko, Jerome Bergeron, Corey Nehls, Robert MacNeill, Andrew Dinan, Esme Farley, Scott Reuschel, Hao Wang, Chantal DiMarco, Timothy Sangster, John Stamatopoulos, Shane Karnik, Nadine Boudreau, Kathie Lindley, Sarah Maasjo, Ariana Tudoroniu, Changming Yang, Jennifer Vance, Christina Satterwhite, Hao Feng, Ira DuBey, Jing Shi, Natasha Savoie, Brian K. Hoffpauir, Kurt J. Sales, Travis Harrison, Orlando Bravo, Jenifer Vija, Jason Ambrosius, Ardeshir Khadang, Chad Briscoe, Stephanie Cape, Edward Tabler, Philippe Couerbe, Adriana Iordachescu, Evgueni Fedorov, Jennifer Zimmer, Roger Hayes, Luca Matassa, Michael H. Buonarati, Franklin Spriggs, Stacie McCown, Michael E. Brown, Wei Garofolo, Jenny Lin, John Lindsay, Paul Rhyne, Shelby Anderson, Bruce Stouffer, Rafiq Islam, John Pirro, Edward Wells, Angie Underberg, Saadya Fatmi, Philip Joyce, Shaolian Zhou, Mohammed Bouhajib, Joseph Bower, Hanna Ritzén, Liam Moran

المصدر: Bioanalysis. 11(18s)

مصطلحات موضوعية: Engineering, Medical education, Validation study, Bioanalysis, business.industry, Event (computing), Clinical Biochemistry, Attendance, Reproducibility of Results, Guidelines as Topic, General Medicine, Guideline, Analytical Chemistry, Medical Laboratory Technology, Research Design, Humans, General Pharmacology, Toxicology and Pharmaceutics, business, Biomarkers

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4f70e570638ab396bb6fddadea18efb8
https://pubmed.ncbi.nlm.nih.gov/31565956

PDF full text from Publisher

Find this article in full text from ProQuest

4

Contract research organization commentary on the importance of harmonization and the impact of ICH M10

المؤلفون: Chad Briscoe, Mike Buonarati, Christina Satterwhite, Stephanie Cape, Rafiq Islam, Corey Nehls, Roger Hayes

المصدر: Bioanalysis. 11(18)

مصطلحات موضوعية: Internationality, business.industry, Research, Clinical Biochemistry, Accounting, Harmonization, Guidelines as Topic, General Medicine, Contract Services, Reference Standards, Analytical Chemistry, Social Control, Formal, Medical Laboratory Technology, Contract research organization, Business, General Pharmacology, Toxicology and Pharmaceutics

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bd41856b55eb2b0b05b9240150aa399c
https://pubmed.ncbi.nlm.nih.gov/31556330

PDF full text from Publisher

Find this article in full text from ProQuest

5

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

PDF full text from Publisher

6

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

المؤلفون: Ira DuBey, Marc Moussallie, Nadia Kulagina, Dave Williams, Corey Nehls, Rabab Tayyem, Michael E. Brown, Wei Garofolo, Edward Tabler, Philippe Couerbe, Ardeshir Khadang, John Lindsay, Michele Malone, Paul Rhyne, Anahita Keyhani, Mark Warren, Jennifer Zimmer, John Stamatopoulos, Sian Estdale, Clark V. Williard, Bruce Stouffer, Eric Thomas, Mathilde Yu, Rafiq Islam, George Hristopoulos, Simona Rizea Savu, Robert MacNeill, Edward Wells, Jenny Lin, Hanna Ritzén, Iohann Boulay, Natasha Savoie, Kayode Awaiye, Vellalore Kakkanaiah, Shane Karnik, Christina Satterwhite, Curtis Sheldon, Amanda Hays, Chad Briscoe, Kathie Lindley, Colin Barry, Yi Qun Xiao, Andrew Dinan, Allan Xu, Luca Matassa, Arron Xu, Lawrence Goodwin, Steve Lowes, Jessica St Charles, Chantal Di Marco, Mohammed Bouhajib, Maria Cruz Caturla, Nicola Hughes, Patrick Bennett, Jenifer Vija, Stephanie Cape, Roger Hayes, Hao Wang, Xinping Fang, James Bourdage, Franklin Spriggs, Chris Beaver

المصدر: Bioanalysis. 11(12)

مصطلحات موضوعية: Societies, Scientific, Bioanalysis, Certification, Immunogenicity, Clinical Biochemistry, Oligonucleotides, General Medicine, Computational biology, Flow Cytometry, Chemistry Techniques, Analytical, Mass Spectrometry, Analytical Chemistry, Social Control, Formal, Medical Laboratory Technology, Indicators and Reagents, Business, General Pharmacology, Toxicology and Pharmaceutics

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::38c4dbb172c392741c64fb7ad82791fa
https://pubmed.ncbi.nlm.nih.gov/31319683

PDF full text from Publisher

Find this article in full text from ProQuest

7

Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis

المؤلفون: Mathilde Yu, Michele Malone, John Stamatopoulos, Christina Satterwhite, George Hristopoulos, Simona Rizea Savu, Mohammed Bouhajib, Chad Briscoe, Edward Tabler, Philippe Couerbe, Edward Wells, Ardeshir Khadang, Ira DuBey, Sian Estdale, Mark Warren, Hanna Ritzén, Wei Garofolo, Franklin Spriggs, Arron Xu, Chris Beaver, Jennifer Zimmer, Iohann Boulay, Anahita Keyhani, Kayode Awaiye, Vellalore Kakkanaiah, Curtis Sheldon, Jessica St Charles, Roger Hayes, Patrick Bennett, James Bourdage, Yi Qun Xiao, Marc Moussallie, Sumit Kar, Shane Karnik, Rabab Tayyem, Maria Cruz Caturla, Clark V. Williard, Hao Wang, Nadia Kulagina, Nicola Hughes, Robert MacNeill, Luigi DiMarco, Andrew Dinan, Kathie Lindley, Natasha Savoie, Xinping Fang, Chantal DiMarco, Bruce Stouffer, Jenifer Vija, Corey Nehls, Stephanie Cape, Eric Thomas, John Lindsay, Paul Rhyne, Michael E. Brown, Jenny Lin, Amanda Hays, Allan Xu, Hao Feng, Lawrence Goodwin, Rafiq Islam, Colin Barry, Dave Williams

المصدر: Bioanalysis. 11(7)

مصطلحات موضوعية: Quality Control, Bioanalysis, Societies, Pharmaceutical, Clinical Biochemistry, Commercial kit, Ligands, 030226 pharmacology & pharmacy, 01 natural sciences, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, White paper, Surveys and Questionnaires, Drug Discovery, Humans, General Pharmacology, Toxicology and Pharmaceutics, health care economics and organizations, End user, 010401 analytical chemistry, General Medicine, Reference Standards, 0104 chemical sciences, Medical Laboratory Technology, Engineering management, ComputingMethodologies_PATTERNRECOGNITION, Contract research organization, Drug development, Pharmaceutical Preparations, Biomarker (medicine), Biological Assay, Business, Reagent Kits, Diagnostic, Biomarkers

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::34219e762535ddd3b0da39d50cd5b1ec
https://pubmed.ncbi.nlm.nih.gov/30993999

PDF full text from Publisher

Find this article in full text from ProQuest

8

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation

المؤلفون: Franklin Spriggs, Chris Beaver, Ashley Brant, Daniel Sikkema, Susan Ohorodnik, John Lindsay, Wei Garofolo, Mike Buonarati, Jing Tu, Chad Briscoe, Scott Fountain, James Hulse, Andrew Dinan, Mark E. Arnold, Rafiq Islam, Saadya Fatmi, James Bourdage, Michael E. Brown, Jim Wilfahrt, Edward Tabler, Philippe Couerbe, Anahita Keyhani, Roger Hayes, Ariana Tudoroniu, Adriana Iordachescu, Kelly Colletti, Jennifer Zemo, Natasha Savoie, Jessica St Charles, John Stamatopoulos, Damon Papac, Colin Barry, Vimal Patel, Gene Ray, Bruce Stouffer, John Marcelletti, Jenny Lin, Jennifer Zimmer, Mark Warren, Mathilde Yu, Maria Cruz Caturla, Philip Joyce, Jenifer Vija, Christina Sanchez, Rachel Green, Xinping Fang, Clark V. Williard, Yansheng Liu, Mohammed Bouhajib, Stephanie Cape, Ira DuBey, Masood Khan, George Hristopoulos, Nicola Hughes, Nadine Boudreau, Barry van der Strate, Rabab Tayyem, Jim Datin, Michael Kennedy, Joanne Hayward-Sewell, Edward Wells, Joseph Bower, Christina Satterwhite, Yi Qun Xiao, Jim Yamashita, Corey Nehls, Curtis Sheldon, Dominic Warrino, Allan Xu, Shane Karnik, Ardeshir Khadang

المصدر: Bioanalysis. 10(7)

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cbf30d52d324aed76d79809c62501fab
https://pubmed.ncbi.nlm.nih.gov/29701066

PDF full text from Publisher

9

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS)

المصدر: Bioanalysis. 8(22)

مصطلحات موضوعية: Engineering, Bioanalysis, business.industry, 010401 analytical chemistry, Clinical Biochemistry, General Medicine, 030226 pharmacology & pharmacy, 01 natural sciences, Data science, 0104 chemical sciences, Analytical Chemistry, Biotechnology, 03 medical and health sciences, Medical Laboratory Technology, 0302 clinical medicine, Biopharmaceutical, White paper, General Pharmacology, Toxicology and Pharmaceutics, business

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::99c7fb8a621a24c425feed2dddda575b
https://pubmed.ncbi.nlm.nih.gov/27712081

PDF full text from Publisher

10

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

المصدر: Bioanalysis. 3:2081-2096

مصطلحات موضوعية: Medical Laboratory Technology, Bioanalysis, White paper, Calibration and validation, Political science, Clinical Biochemistry, Scientific excellence, Engineering ethics, Nanotechnology, General Medicine, Audit, General Pharmacology, Toxicology and Pharmaceutics, Analytical Chemistry

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::56f3bb46ad8031b74395947656f3f6b3
https://doi.org/10.4155/bio.11.192

PDF full text from Publisher

تنقيح النتائج