Publication

8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation

GCC Closed Forum for Bioanalysis, Bower, J., Fast, D., Garofolo, F., Gouty, D., Hayes, R., Lowes, S., Nicholson, R., LeLacheur, R., Bravo, J., Shoup, R., Dumont, I., Carbone, M., Zimmer, J., Ortuno, J., Cruz Caturla, M., Datin, J., Lansing, T., Fatmi, S., Struwe, P., Sheldon, C., Islam, R., Yu, M., Hulse, J., Kamerud, J., Lin, J., Doughty, J., Kurylak, K., Tang, D., Buonarati, M., Blanchette, A., Levesque, A., Gagnon-Carignan, S., Lin, J., Ray, G., Liu, Y., Khan, M., Xu, A., el-Sulayman, G., DiMarco, C., Bouhajib, M., Tacey, D., Jenkins, R., van der Strate, B., Briscoe, C., Karnik, S., Rhyne, P., Garofolo, W., Schultz, G., Roberts, A. & Redrup, M., 2014, In : Bioanalysis. 6, 22, p. 2957-2963 7 p.

Research output: Contribution to journalArticleAcademicpeer-review

APA

GCC Closed Forum for Bioanalysis, Bower, J., Fast, D., Garofolo, F., Gouty, D., Hayes, R., ... Redrup, M. (2014). 8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation. Bioanalysis, 6(22), 2957-2963. https://doi.org/10.4155/bio.14.287

Author

GCC Closed Forum for Bioanalysis ; Bower, Joseph ; Fast, Douglas ; Garofolo, Fabio ; Gouty, Dominique ; Hayes, Roger ; Lowes, Steve ; Nicholson, Robert ; LeLacheur, Richard ; Bravo, Jennifer ; Shoup, Ronald ; Dumont, Isabelle ; Carbone, Mary ; Zimmer, Jennifer ; Ortuno, Jordi ; Cruz Caturla, Maria ; Datin, Jim ; Lansing, Tim ; Fatmi, Saadya ; Struwe, Petra ; Sheldon, Curtis ; Islam, Rafiqul ; Yu, Mathilde ; Hulse, Jim ; Kamerud, John ; Lin, John ; Doughty, John ; Kurylak, Kai ; Tang, Daniel ; Buonarati, Mike ; Blanchette, Alexandre ; Levesque, Ann ; Gagnon-Carignan, Sofi ; Lin, Jenny ; Ray, Gene ; Liu, Yanseng ; Khan, Masood ; Xu, Allan ; el-Sulayman, Gibran ; DiMarco, Chantal ; Bouhajib, Mohammed ; Tacey, Dick ; Jenkins, Rand ; van der Strate, Barry ; Briscoe, Chad ; Karnik, Shane ; Rhyne, Paul ; Garofolo, Wei ; Schultz, Gary ; Roberts, Andrew ; Redrup, Mike. / 8th GCC : Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation. In: Bioanalysis. 2014 ; Vol. 6, No. 22. pp. 2957-2963.

Harvard

GCC Closed Forum for Bioanalysis, Bower, J, Fast, D, Garofolo, F, Gouty, D, Hayes, R, Lowes, S, Nicholson, R, LeLacheur, R, Bravo, J, Shoup, R, Dumont, I, Carbone, M, Zimmer, J, Ortuno, J, Cruz Caturla, M, Datin, J, Lansing, T, Fatmi, S, Struwe, P, Sheldon, C, Islam, R, Yu, M, Hulse, J, Kamerud, J, Lin, J, Doughty, J, Kurylak, K, Tang, D, Buonarati, M, Blanchette, A, Levesque, A, Gagnon-Carignan, S, Lin, J, Ray, G, Liu, Y, Khan, M, Xu, A, el-Sulayman, G, DiMarco, C, Bouhajib, M, Tacey, D, Jenkins, R, van der Strate, B, Briscoe, C, Karnik, S, Rhyne, P, Garofolo, W, Schultz, G, Roberts, A & Redrup, M 2014, '8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation', Bioanalysis, vol. 6, no. 22, pp. 2957-2963. https://doi.org/10.4155/bio.14.287

Standard

8th GCC : Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation. / GCC Closed Forum for Bioanalysis; Bower, Joseph; Fast, Douglas; Garofolo, Fabio; Gouty, Dominique; Hayes, Roger; Lowes, Steve; Nicholson, Robert; LeLacheur, Richard; Bravo, Jennifer; Shoup, Ronald; Dumont, Isabelle; Carbone, Mary; Zimmer, Jennifer; Ortuno, Jordi; Cruz Caturla, Maria; Datin, Jim; Lansing, Tim; Fatmi, Saadya; Struwe, Petra; Sheldon, Curtis; Islam, Rafiqul; Yu, Mathilde; Hulse, Jim; Kamerud, John; Lin, John; Doughty, John; Kurylak, Kai; Tang, Daniel; Buonarati, Mike; Blanchette, Alexandre; Levesque, Ann; Gagnon-Carignan, Sofi; Lin, Jenny; Ray, Gene; Liu, Yanseng; Khan, Masood; Xu, Allan; el-Sulayman, Gibran; DiMarco, Chantal; Bouhajib, Mohammed; Tacey, Dick; Jenkins, Rand; van der Strate, Barry; Briscoe, Chad; Karnik, Shane; Rhyne, Paul; Garofolo, Wei; Schultz, Gary; Roberts, Andrew; Redrup, Mike.

In: Bioanalysis, Vol. 6, No. 22, 2014, p. 2957-2963.

Research output: Contribution to journalArticleAcademicpeer-review

Vancouver

GCC Closed Forum for Bioanalysis, Bower J, Fast D, Garofolo F, Gouty D, Hayes R et al. 8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation. Bioanalysis. 2014;6(22):2957-2963. https://doi.org/10.4155/bio.14.287


BibTeX

@article{fc3cff5cfe73438ea87685d85704a45a,
title = "8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation",
abstract = "The 8(th) GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation - The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.",
keywords = "GLOBAL CRO COUNCIL, RECENT ISSUES, WHITE PAPER, RECOMMENDATIONS, STABILITY, GUIDELINES, ASSAYS, DRUGS, 483S, LBA",
author = "{GCC Closed Forum for Bioanalysis} and Joseph Bower and Douglas Fast and Fabio Garofolo and Dominique Gouty and Roger Hayes and Steve Lowes and Robert Nicholson and Richard LeLacheur and Jennifer Bravo and Ronald Shoup and Isabelle Dumont and Mary Carbone and Jennifer Zimmer and Jordi Ortuno and {Cruz Caturla}, Maria and Jim Datin and Tim Lansing and Saadya Fatmi and Petra Struwe and Curtis Sheldon and Rafiqul Islam and Mathilde Yu and Jim Hulse and John Kamerud and John Lin and John Doughty and Kai Kurylak and Daniel Tang and Mike Buonarati and Alexandre Blanchette and Ann Levesque and Sofi Gagnon-Carignan and Jenny Lin and Gene Ray and Yanseng Liu and Masood Khan and Allan Xu and Gibran el-Sulayman and Chantal DiMarco and Mohammed Bouhajib and Dick Tacey and Rand Jenkins and {van der Strate}, Barry and Chad Briscoe and Shane Karnik and Paul Rhyne and Wei Garofolo and Gary Schultz and Andrew Roberts and Mike Redrup",
year = "2014",
doi = "10.4155/bio.14.287",
language = "English",
volume = "6",
pages = "2957--2963",
journal = "Bioanalysis",
issn = "1757-6180",
publisher = "FUTURE SCI LTD",
number = "22",

}

RIS

TY - JOUR

T1 - 8th GCC

T2 - Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation

AU - GCC Closed Forum for Bioanalysis

AU - Bower, Joseph

AU - Fast, Douglas

AU - Garofolo, Fabio

AU - Gouty, Dominique

AU - Hayes, Roger

AU - Lowes, Steve

AU - Nicholson, Robert

AU - LeLacheur, Richard

AU - Bravo, Jennifer

AU - Shoup, Ronald

AU - Dumont, Isabelle

AU - Carbone, Mary

AU - Zimmer, Jennifer

AU - Ortuno, Jordi

AU - Cruz Caturla, Maria

AU - Datin, Jim

AU - Lansing, Tim

AU - Fatmi, Saadya

AU - Struwe, Petra

AU - Sheldon, Curtis

AU - Islam, Rafiqul

AU - Yu, Mathilde

AU - Hulse, Jim

AU - Kamerud, John

AU - Lin, John

AU - Doughty, John

AU - Kurylak, Kai

AU - Tang, Daniel

AU - Buonarati, Mike

AU - Blanchette, Alexandre

AU - Levesque, Ann

AU - Gagnon-Carignan, Sofi

AU - Lin, Jenny

AU - Ray, Gene

AU - Liu, Yanseng

AU - Khan, Masood

AU - Xu, Allan

AU - el-Sulayman, Gibran

AU - DiMarco, Chantal

AU - Bouhajib, Mohammed

AU - Tacey, Dick

AU - Jenkins, Rand

AU - van der Strate, Barry

AU - Briscoe, Chad

AU - Karnik, Shane

AU - Rhyne, Paul

AU - Garofolo, Wei

AU - Schultz, Gary

AU - Roberts, Andrew

AU - Redrup, Mike

PY - 2014

Y1 - 2014

N2 - The 8(th) GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation - The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.

AB - The 8(th) GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation - The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.

KW - GLOBAL CRO COUNCIL

KW - RECENT ISSUES

KW - WHITE PAPER

KW - RECOMMENDATIONS

KW - STABILITY

KW - GUIDELINES

KW - ASSAYS

KW - DRUGS

KW - 483S

KW - LBA

U2 - 10.4155/bio.14.287

DO - 10.4155/bio.14.287

M3 - Article

VL - 6

SP - 2957

EP - 2963

JO - Bioanalysis

JF - Bioanalysis

SN - 1757-6180

IS - 22

ER -

ID: 79153539