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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.

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

    Final publisher's version, 941 KB, PDF document

DOI

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

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.

Original languageEnglish
Pages (from-to)2957-2963
Number of pages7
JournalBioanalysis
Volume6
Issue number22
Publication statusPublished - 2014
Externally publishedYes

    Keywords

  • GLOBAL CRO COUNCIL, RECENT ISSUES, WHITE PAPER, RECOMMENDATIONS, STABILITY, GUIDELINES, ASSAYS, DRUGS, 483S, LBA

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