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1. 2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (<u>Part 2</u> – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

Author

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, and Haoheng Yan

Subjects
Bioanalysis, Immunogenicity, 010401 analytical chemistry, Clinical Biochemistry, Scientific excellence, General Medicine, Guideline, 030226 pharmacology & pharmacy, 01 natural sciences, Method development, 0104 chemical sciences, Analytical Chemistry, 03 medical and health sciences, Medical Laboratory Technology, Engineering management, 0302 clinical medicine, White paper, Biopharmaceutical, Business, General Pharmacology, Toxicology and Pharmaceutics
Abstract

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA on 1–5 April 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on the 2018 FDA BMV guidance, 2019 ICH M10 BMV draft guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy. Part 1 (Innovation in small molecules and oligonucleotides and mass spectrometry method development strategies for large molecules bioanalysis) and Part 3 (New insights in biomarker assay validation, current and effective strategies for critical reagent management, flow cytometry validation in drug discovery and development and CLSI H62, interpretation of the 2019 FDA immunogenicity guidance and gene therapy bioanalytical challenges) are published in volume 10 of Bioanalysis, issues 22 and 24 (2019), respectively.

Published
2019
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2. 7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing

Author

Rocci, Mario, Lowes, Steve, Shoup, Ronald, Garofolo, Fabio, Farmen, Raymond, Zhang, Tianyi, Allinson, John, Gouty, Dominique, Hayes, Roger, Nicholson, Robert, Houghton, Richard, Dumont, Isabelle, LeLacheur, Richard, Zimmer, Jennifer, Caturla, Maria Cruz, Couerbe, Philippe, Awaiye, Kayode, Fatmi, Saadya, Sheldon, Curtis, Bower, Joseph, Fiscella, Michelle, Fast, Douglas, Cape, Stephanie, Hulse, Jim, Kamerud, John, Pasas-Farmer, Stephanie, Garofolo, Wei, Moussallie, Marc, Buonarati, Mike, Boudreau, Nadine, Pellerin, Brigitte, Lin, Jenny, Xu, Allan, Bouhajib, Mohammed, Stipancic, Mary, Nehls, Corey, Warren, Mark, Karnik, Shane, Stovold, Craig, Reuschel, Scott, Cojocaru, Laura, Marcelletti, John, Fang, Xinping, Smith, Ian, and Watson, Andrea

Published
2014
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3. Recommendations on incurred sample stability (ISS) by GCC

Author

Lowes, Steve, LeLacheur, Richard, Shoup, Ronald, Garofolo, Fabio, Dumont, Isabelle, Martinez, Suzanne, Zimmer, Jennifer, Caturla, Maria Cruz, Couerbe, Philippe, Awaiye, Kayode, Fatmi, Saadya, Farmen, Raymond, Sheldon, Curtis, Bower, Joseph, Fiscella, Michele, Fast, Douglas, Cape, Stephanie, Hulse, Jim, Kamerud, John, Zhang, Tee, Pasas-Farmer, Stephanie, Garofolo, Wei, Moussallie, Marc, Rocci, Mario, Allinson, John, Gouty, Dominique, Buonarati, Mike, Boudreau, Nadine, Pellerin, Brigitte, Lin, Jenny, Xu, Allan, Hayes, Roger, Bouhajib, Mohammed, Stipancic, Mary, Nicholson, Robert, Nehls, Corey, Warren, Mark, Karnik, Shane, Houghton, Richard, Stovold, Craig, Reuschel, Scott, Cojocaru, Laura, Marcelletti, John, Fang, Xinping, Smith, Ian, and Watson, Andrea

Published
2014
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4. 2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

Author

Garofolo, Fabio, Rocci, Mario L, Dumont, Isabelle, Martinez, Suzanne, Lowes, Steve, Woolf, Eric, van Amsterdam, Peter, Bansal, Surendra, Barra, Ariadna Cristina Gomes, Bauer, Ronald, Booth, Brian P, Carrasco-Triguero, Montserrat, DeSilva, Binodh, Dunn, John, Gallicano, Keith, Gouty, Dominique, Ho, Stacy, Hucker, Richard, Jemal, Mohammed, Katori, Noriko, Le Blaye, Olivier, Lee, Jean, Li, Wenkui, Michael, Steve, Nehls, Corey, Nicholson, Robert, Ormsby, Eric, Tang, Daniel, Viswanathan, CT, Weiner, Russell, and Young, Graeme

Published
2011
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5. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

Author

Lowes, Steve, Jersey, Jim, Shoup, Ronald, Garofolo, Fabio, Savoie, Natasha, Mortz, Ejvind, Needham, Shane, Caturla, Maria Cruz, Steffen, Ray, Sheldon, Curtis, Hayes, Roger, Samuels, Tim, Di Donato, Lorella, Kamerud, John, Michael, Steve, Lin, Zhongping (John), Hillier, Jim, Moussallie, Marc, de Souza Teixeira, Leonardo, Rocci, Mario, Buonarati, Mike, Truog, James, Hussain, Saleh, Lundberg, Richard, Breau, Alan, Zhang, Tianyi, Jonker, Jianine, Berger, Neil, Gagnon-Carignan, Sofi, Nehls, Corey, Nicholson, Robert, Hilhorst, Martijn, Karnik, Shane, de Boer, Theo, Houghton, Richard, Smith, Kirk, Cojocaru, Laura, Allen, Mike, Harter, Tammy, Fatmi, Saadya, Sayyarpour, Farhad, Vija, Jenifer, Malone, Michele, and Heller, Dennis

Published
2011
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6. 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

Author

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, and Michele Fiscella

Subjects
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
Abstract

The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO–Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.

Published
2017
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7. GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline

Author

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, and Liam Moran

Subjects
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
Abstract

The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.

Published
2019

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

Author

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

Subjects
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
Published
2019

9. 12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

Author

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, and Chris Beaver

Subjects
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
Abstract

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.

Published
2019

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

Author

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, and Dave Williams

Subjects
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
Abstract

Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members’ opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.

Published
2019

11. 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

Author

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, and Ardeshir Khadang

Subjects
Bioanalysis, China, Computer science, Matrix stability, 010401 analytical chemistry, Clinical Biochemistry, Biosimilar, General Medicine, 030226 pharmacology & pharmacy, 01 natural sciences, 0104 chemical sciences, Analytical Chemistry, Food and drug administration, 03 medical and health sciences, Medical Laboratory Technology, Engineering management, 0302 clinical medicine, Research Design, Humans, Biological Assay, Sample collection, General Pharmacology, Toxicology and Pharmaceutics, Laboratory Manuals, Biosimilar Pharmaceuticals, Biomarkers
Abstract

The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO–Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives’ sharing perspectives on the topics discussed earlier in the week with the CRO members. The issues discussed at the meetings included cumulative stability evaluations, matrix stability evaluations, the 2016 US FDA Immunogenicity Guidance and recent and unexpected FDA Form 483s on immunogenicity assays, the bioanalytical laboratory's role in writing PK sample collection instructions, biosimilars, CRO perspectives on the use of chiral versus achiral methods, hybrid LBA/LCMS assays, applications of fit-for-purpose validation and, at the Global CRO Council Closed Forum only, the status and trend of current regulated bioanalytical practice in China under CFDA's new BMV policy. Conclusions from discussions of these topics at both meetings are included in this report.

Published
2018

12. 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)

Author

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

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

Author

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

Published
2019
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15. 12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

Author

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

Published
2019
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16. Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis

Author

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

Published
2019
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17. 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

Author

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

Published
2018
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18. 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)

Author

Ragu Ramanathan, Christopher P. Evans, Rachel Sun, Eugene Ciccimaro, Corey Nehls, Ronald Bauer, Eric Yang, Adrien Musuku, Rand Jenkins, Lloyd King, Daniela Fraier, Jason Wakelin-Smith, Chad Briscoe, Dieter M. Drexler, Christopher A. James, Michael H. Buonarati, Wenkui Li, Jan Welink, Laura Coppola, Gustavo Mendes Lima Santos, Stephanie Cape, Dina Goykhman, Rafiq Islam, Yoshiro Saito, Scott G. Summerfield, Raj Dodda, Steve Vinter, Amanda Wilson, Nicola Hughes, Nilufer Tampal, Stephanie Croft, Neil Addock, Qin Yue, Natasha Savoie, Mark Bustard, Fabio Garofolo, Eric Woolf, Mark E. Arnold, John Kadavil, Jens Sydor, and Luca Ferrari

Subjects
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
Abstract

The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event – A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This white paper is published in 3 parts due to length. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LCMS. Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in the Bioanalysis journal, issue 23.

Published
2016

19. 2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

Author

Robert Nicholson, Eric Ormsby, Corey Nehls, Mario Rocci, Olivier Le Blaye, CT Viswanathan, Mohammed Jemal, Isabelle Dumont, Jean W. Lee, Daniel Tang, Steve Lowes, Stacy Ho, Peter van Amsterdam, Surendra Bansal, Fabio Garofolo, Steve Michael, Graeme Young, Ronald Bauer, Keith Gallicano, Russell Weiner, Richard Hucker, Brian Booth, Noriko Katori, Montserrat Carrasco-Triguero, Binodh DeSilva, Wenkui Li, Ariadna Cristina Gomes Barra, Suzanne Martinez, Eric Woolf, John Dunn, and Dominique Gouty

Subjects
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
Abstract

The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many ‘hot’ topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.

Published
2011
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20. 7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing

Author

Nadine Boudreau, Saadya Fatmi, Richard LeLacheur, Raymond Farmen, John Allinson, Mohammed Bouhajib, Tianyi Zhang, Mike Buonarati, Ronald Shoup, Mary Stipancic, Brigitte Pellerin, Philippe Couerbe, Joseph Bower, Stephanie Cape, Michelle Fiscella, Marc Moussallie, Jim Hulse, Robert Ian Nicholson, Stephanie Pasas-Farmer, Ian E. Smith, Jennifer Zimmer, Mark Warren, Andrea Watson, John Kamerud, Douglas M. Fast, Allan Xu, Laura Cojocaru, Scott Reuschel, Isabelle Dumont, Jenny Lin, Dominique Gouty, Mario Rocci, Fabio Garofolo, Steve Lowes, Curtis Sheldon, Richard Houghton, Craig Stovold, Xinping Fang, Kayode Awaiye, Roger Hayes, Shane Karnik, Corey Nehls, John Marcelletti, Maria Cruz Caturla, and Wei Garofolo

Subjects
business.industry, Clinical Laboratory Techniques, Clinical Biochemistry, Attendance, Guidelines as Topic, Hyperlipidemias, General Medicine, Public relations, Analytical Chemistry, Outsourcing, Medical Laboratory Technology, Political science, Electronic Health Records, Humans, General Pharmacology, Toxicology and Pharmaceutics, business, Biomarkers
Abstract

The Global CRO Council for Bioanalysis (GCC), a global independent consortium bringing together many senior level CRO representatives, was created in 2010 in order to openly discuss and share opinions on scientific and regulatory issues specific to the bioanalytical field [1]. Since its formation, the GCC members have met on a regular basis to discuss various topics and challenges faced by bioanalytical CRO companies. Several conference reports of past GCC meetings were published to share the discussions held during these events [2–4]. In addition, the GCC also published several influential White Papers on topics of widespread interest in bioanalysis [5–9]. These White Papers provide unified GCC recommendations that are helpful to the global bioanalytical community. The 7th GCC Closed Forum for Bioanalysis took place in Long Beach, CA, USA on 8 April 2013, one day before the start of the 7th Workshop on Recent Issues in Bioanalysis (WRIB). In attendance were 46 senior-level participants from six countries, representing 37 bioanalytical CRO companies/sites. This event represented a good opportunity for bioanalytical experts from CROs to share and discuss these issues of concern for the outsourcing industry. The 7th GCC Closed Forum was chaired by Mario Rocci, who started the meeting by communicating the official admonition statement, as has been done in all previous editions [1]. Prior to initiating discussions, participants introduced themselves. As in previous GCC meetings, multiple topics of 7th GCC Insights: incurred samples use; fitfor-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing

Published
2014

21. Recommendations on incurred sample stability (ISS) by GCC

Author

Saadya Fatmi, Mary Stipancic, Roger Hayes, Andrea Watson, Tee Zhang, Laura Cojocaru, John Allinson, Stephanie Pasas-Farmer, Kayode Awaiye, Shane Karnik, Douglas M. Fast, John Kamerud, Steve Lowes, Mohammed Bouhajib, Michele Fiscella, Ian E. Smith, Dominique Gouty, Ronald Shoup, John Marcelletti, Isabelle Dumont, Raymond Farmen, Mike Buonarati, Xinping Fang, Nadine Boudreau, Joseph Bower, Curtis Sheldon, Philippe Couerbe, Richard LeLacheur, Marc Moussallie, Jim Hulse, Stephanie Cape, Jenny Lin, Mark Warren, Jennifer Zimmer, Richard Houghton, Craig Stovold, Fabio Garofolo, Scott Reuschel, Corey Nehls, Mario Rocci, Suzanne Martinez, Brigitte Pellerin, Maria Cruz Caturla, Wei Garofolo, Robert Ian Nicholson, and Allan Xu

Subjects
business.industry, Data Collection, Clinical Biochemistry, Reproducibility of Results, Context (language use), Nanotechnology, Survey result, Accounting, Clinical Chemistry Tests, General Medicine, Method development, Sample stability, Analytical Chemistry, Medical Laboratory Technology, Political science, General Pharmacology, Toxicology and Pharmaceutics, business
Abstract

The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual Workshop on Recent Issues in Bioanalysis (WRIB) held in Long Beach, CA, USA, in April 2013, and at the Global CRO Council for Bioanalysis (GCC) meeting preceding it. Discussion at both events focused on the use of incurred samples for ISS purposes in light of results from a recent GCC survey completed by member companies. This paper reports the consensus resulting from these discussions and serves as a useful reference for depicting ISS issues and concerns, summarizing the GCC survey results and providing helpful recommendations on ISS in the context of bioanalytical method development and application.

Published
2014

22. 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

Author

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

Published
2017
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23. 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)

Author

Yang, Eric, primary, Welink, Jan, additional, Cape, Stephanie, additional, Woolf, Eric, additional, Sydor, Jens, additional, James, Christopher, additional, Goykhman, Dina, additional, Arnold, Mark, additional, Addock, Neil, additional, Bauer, Ronald, additional, Buonarati, Michael, additional, Ciccimaro, Eugene, additional, Dodda, Raj, additional, Evans, Christopher, additional, Garofolo, Fabio, additional, Hughes, Nicola, additional, Islam, Rafiq, additional, Nehls, Corey, additional, Wilson, Amanda, additional, Briscoe, Chad, additional, Bustard, Mark, additional, Coppola, Laura, additional, Croft, Stephanie, additional, Drexler, Dieter, additional, Ferrari, Luca, additional, Fraier, Daniela, additional, Jenkins, Rand, additional, Kadavil, John, additional, King, Lloyd, additional, Li, Wenkui, additional, Lima Santos, Gustavo Mendes, additional, Musuku, Adrien, additional, Ramanathan, Ragu, additional, Saito, Yoshiro, additional, Savoie, Natasha, additional, Summerfield, Scott, additional, Sun, Rachel, additional, Tampal, Nilufer, additional, Vinter, Steve, additional, Wakelin-Smith, Jason, additional, and Yue, Qin, additional

Published
2016
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24. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

Author

Shane Karnik, Corey Nehls, Lorella Di Donato, Shane Needham, Saadya Fatmi, Jim Hillier, James Truog, Mike Allen, Mario Rocci, Dennis Heller, Kirk R. Smith, Ejvind Mørtz, Curtis Sheldon, Farhad Sayyarpour, Theo de Boer, Ronald Shoup, Natasha Savoie, Zhongping John Lin, Jenifer Vija, Ray Steffen, Robert Nicholson, John Kamerud, Alan Breau, Neil Berger, Leonardo de Souza Teixeira, Sofi Gagnon-Carignan, Richard Lundberg, Laura Cojocaru, Maria Cruz Caturla, Jim Jersey, Saleh Hussain, Jianine Jonker, Steve Lowes, Richard Houghton, Michele Malone, Marc Moussallie, Fabio Garofolo, Steve Michael, Tammy Harter, Martijn Hilhorst, Roger Hayes, Tim Samuels, Mike Buonarati, and Tianyi Zhang

Subjects
Quality Control, Bioanalysis, business.industry, International Cooperation, Clinical Biochemistry, Nanotechnology, Accounting, Sample (statistics), General Medicine, Reference Standards, Chemistry Techniques, Analytical, Analytical Chemistry, Outsourcing, Biopharmaceutics, Medical Laboratory Technology, Drug Stability, General Pharmacology, Toxicology and Pharmaceutics, business
Abstract

“The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry”

Published
2011

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