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Bioanalytical Method

The Experts below are selected from a list of 6639 Experts worldwide ranked by ideXlab platform

Steve Lowes – 1st expert on this subject based on the ideXlab platform

  • aaps and us fda crystal city vi workshop on Bioanalytical Method validation for biomarkers
    Bioanalysis, 2016
    Co-Authors: Steve Lowes, Bradley L Ackermann

    Abstract:

    Crystal City VI Workshop on Bioanalytical Method Validation of Biomarkers, Renaissance Baltimore Harborplace Hotel, Baltimore, MD, USA, 28–29 September 2015 The Crystal City VI workshop was organized by the American Association of Pharmaceutical Scientists in association with the US FDA to continue discussion on the bioanalysis of biomarkers. An outcome of the Crystal City V workshop, convened following release of the draft FDA Guidance for Industry on Bioanalytical Methods Validation in 2013 was the need to have further discussion on biomarker Methods. Biomarkers ultimately became the sole focal point for Crystal City VI, a meeting attended by approximately 200 people and composed of industry scientists and regulators from around the world. The meeting format included several panel discussions to maximize the opportunity for dialogue among participants. Following an initial session on the general topic of biomarker assays and intended use, more focused sessions were held on chromatographic (LC–MS) and li…

  • Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
    The AAPS Journal, 2015
    Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve Lowes

    Abstract:

    In September 2013, the FDA released a draft revision of the Bioanalytical Method Validation (BMV) Guidance, which included a number of changes to the expectations for bioanalysis, most notably the inclusion of biomarker assays and data. To provide a forum for an open, inclusive discussion of the revised draft BMV Guidance, the AAPS and FDA once again collaborated to convene a two-and-a-half day workshop during early December 2013 in Baltimore, MD, USA. The resulting format embodied extensive open discussion and each thematic session included only brief, concise descriptions by Agency and industry representatives prior to opening the floor discussion. The Workshop was built around four thematic sessions (Common Topics, Chromatographic, Ligand-Binding Assays, and Biomarkers) and a final session with international regulators, concluding with a review of the outcomes and recommendations from the thematic sessions. This Workshop report summarizes the outcomes and includes topics of agreement, those where the FDA will consider the Industry’s perspective, and those where the workshop provided a first open dialogue. This article will be available to the Bioanalytical community at http://www.aaps.org/BMV13 .

  • workshop report crystal city v quantitative Bioanalytical Method validation and implementation the 2013 revised fda guidance
    Aaps Journal, 2015
    Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve Lowes

    Abstract:

    In September 2013, the FDA released a draft revision of the Bioanalytical Method Validation (BMV) Guidance, which included a number of changes to the expectations for bioanalysis, most notably the inclusion of biomarker assays and data. To provide a forum for an open, inclusive discussion of the revised draft BMV Guidance, the AAPS and FDA once again collaborated to convene a two-and-a-half day workshop during early December 2013 in Baltimore, MD, USA. The resulting format embodied extensive open discussion and each thematic session included only brief, concise descriptions by Agency and industry representatives prior to opening the floor discussion. The Workshop was built around four thematic sessions (Common Topics, Chromatographic, Ligand-Binding Assays, and Biomarkers) and a final session with international regulators, concluding with a review of the outcomes and recommendations from the thematic sessions. This Workshop report summarizes the outcomes and includes topics of agreement, those where the FDA will consider the Industry’s perspective, and those where the workshop provided a first open dialogue. This article will be available to the Bioanalytical community at http://www.aaps.org/BMV13.

Fabio Garofolo – 2nd expert on this subject based on the ideXlab platform

  • 8th gcc consolidated feedback to us fda on the 2013 draft fda guidance on Bioanalytical Method validation
    Bioanalysis, 2014
    Co-Authors: Joseph Bower, Dominique Gouty, Steve Lowes, Richard Lelacheur, Fabio Garofolo, Roger Hayes, Douglas Fast, Robert Nicholson, Jennifer Bravo, Ronald Shoup

    Abstract:

    The 8th 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.

  • recommendations on biomarker Bioanalytical Method validation by gcc
    Bioanalysis, 2012
    Co-Authors: Richard Hougton, Dominique Gouty, John Allinson, Rachel Green, Mike Losauro, Steve Lowes, Richard Lelacheur, Fabio Garofolo, Philippe Couerbe, Stephane Bronner

    Abstract:

    The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker Bioanalytical Method validation.

  • confirmation of no impact from different anticoagulant counter ions on Bioanalytical Method
    Bioanalysis, 2012
    Co-Authors: Annik Bergeron, Melanie Bergeron, Fabio Garofolo

    Abstract:

    Background: In the past several years, the impact of changing counter ions while keeping the same anticoagulant in Bioanalytical LC–MS/MS Methods has become a highly discussed topic. In order to confirm that there is no impact from counter ions, matrix effect and stability evaluations were performed on bicalutamide LC–MS/MS Bioanalytical Methods. Results: Independently from the anticoagulant counter ion used, the matrix effect evaluation met acceptance criteria, even when using conditions expected to increase matrix effect, such as protein precipitation with an analog internal standard. Freeze–thaw along with storage stabilities, namely short- and long-term, demonstrated less than 8% deviation regardless of the counter ion used. Conclusion: Differences in the anticoagulant counter ion used has no impact on the bicalutamide Bioanalytical LC–MS/MS Method.

Binodh Desilva – 3rd expert on this subject based on the ideXlab platform

  • Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
    The AAPS Journal, 2015
    Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve Lowes

    Abstract:

    In September 2013, the FDA released a draft revision of the Bioanalytical Method Validation (BMV) Guidance, which included a number of changes to the expectations for bioanalysis, most notably the inclusion of biomarker assays and data. To provide a forum for an open, inclusive discussion of the revised draft BMV Guidance, the AAPS and FDA once again collaborated to convene a two-and-a-half day workshop during early December 2013 in Baltimore, MD, USA. The resulting format embodied extensive open discussion and each thematic session included only brief, concise descriptions by Agency and industry representatives prior to opening the floor discussion. The Workshop was built around four thematic sessions (Common Topics, Chromatographic, Ligand-Binding Assays, and Biomarkers) and a final session with international regulators, concluding with a review of the outcomes and recommendations from the thematic sessions. This Workshop report summarizes the outcomes and includes topics of agreement, those where the FDA will consider the Industry’s perspective, and those where the workshop provided a first open dialogue. This article will be available to the Bioanalytical community at http://www.aaps.org/BMV13 .

  • workshop report crystal city v quantitative Bioanalytical Method validation and implementation the 2013 revised fda guidance
    Aaps Journal, 2015
    Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve Lowes

    Abstract:

    In September 2013, the FDA released a draft revision of the Bioanalytical Method Validation (BMV) Guidance, which included a number of changes to the expectations for bioanalysis, most notably the inclusion of biomarker assays and data. To provide a forum for an open, inclusive discussion of the revised draft BMV Guidance, the AAPS and FDA once again collaborated to convene a two-and-a-half day workshop during early December 2013 in Baltimore, MD, USA. The resulting format embodied extensive open discussion and each thematic session included only brief, concise descriptions by Agency and industry representatives prior to opening the floor discussion. The Workshop was built around four thematic sessions (Common Topics, Chromatographic, Ligand-Binding Assays, and Biomarkers) and a final session with international regulators, concluding with a review of the outcomes and recommendations from the thematic sessions. This Workshop report summarizes the outcomes and includes topics of agreement, those where the FDA will consider the Industry’s perspective, and those where the workshop provided a first open dialogue. This article will be available to the Bioanalytical community at http://www.aaps.org/BMV13.

  • Bioanalytical Method validation: concepts, expectations and challenges in small molecule and macromolecule–a report of PITTCON 2013 symposium.
    Aaps Journal, 2014
    Co-Authors: Edward D. Bashaw, Binodh Desilva, Mark J. Rose, Yow-ming C. Wang, Chinmay G. Shukla

    Abstract:

    The concepts, importance, and implications of Bioanalytical Method validation has been discussed and debated for a long time. The recent high profile issues related to Bioanalytical Method validation at both Cetero Houston and former MDS Canada has brought this topic back in the limelight. Hence, a symposium on Bioanalytical Method validation with the aim of revisiting the building blocks as well as discussing the challenges and implications on the bioanalysis of both small molecules and macromolecules was featured at the PITTCON 2013 Conference and Expo. This symposium was cosponsored by the American Chemical Society (ACS)—Division of Analytical Chemistry and Analysis and Pharmaceutical Quality (APQ) Section of the American Association of Pharmaceutical Scientists (AAPS) and featured leading speakers from the Food & Drug Administration (FDA), academia, and industry. In this symposium, the speakers shared several unique examples, and this session also provided a platform to discuss the need for continuous vigilance of the Bioanalytical Methods during drug discovery and development. The purpose of this article is to provide a concise report on the materials that were presented.