The Experts below are selected from a list of 6639 Experts worldwide ranked by ideXlab platform
Steve Lowes - One of the best experts on this subject based on the ideXlab platform.
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aaps and us fda crystal city vi workshop on Bioanalytical Method validation for biomarkers
Bioanalysis, 2016Co-Authors: Steve Lowes, Bradley L AckermannAbstract: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...
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Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
The AAPS Journal, 2015Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve LowesAbstract: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 .
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workshop report crystal city v quantitative Bioanalytical Method validation and implementation the 2013 revised fda guidance
Aaps Journal, 2015Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve LowesAbstract: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.
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8th gcc consolidated feedback to us fda on the 2013 draft fda guidance on Bioanalytical Method validation
Bioanalysis, 2014Co-Authors: Joseph Bower, Dominique Gouty, Steve Lowes, Richard Lelacheur, Fabio Garofolo, Roger Hayes, Douglas Fast, Robert Nicholson, Jennifer Bravo, Ronald ShoupAbstract: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.
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recommendations on biomarker Bioanalytical Method validation by gcc
Bioanalysis, 2012Co-Authors: Richard Hougton, Dominique Gouty, John Allinson, Rachel Green, Mike Losauro, Steve Lowes, Richard Lelacheur, Fabio Garofolo, Philippe Couerbe, Stephane BronnerAbstract: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.
Fabio Garofolo - One of the best experts on this subject based on the ideXlab platform.
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8th gcc consolidated feedback to us fda on the 2013 draft fda guidance on Bioanalytical Method validation
Bioanalysis, 2014Co-Authors: Joseph Bower, Dominique Gouty, Steve Lowes, Richard Lelacheur, Fabio Garofolo, Roger Hayes, Douglas Fast, Robert Nicholson, Jennifer Bravo, Ronald ShoupAbstract: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.
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recommendations on biomarker Bioanalytical Method validation by gcc
Bioanalysis, 2012Co-Authors: Richard Hougton, Dominique Gouty, John Allinson, Rachel Green, Mike Losauro, Steve Lowes, Richard Lelacheur, Fabio Garofolo, Philippe Couerbe, Stephane BronnerAbstract: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.
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confirmation of no impact from different anticoagulant counter ions on Bioanalytical Method
Bioanalysis, 2012Co-Authors: Annik Bergeron, Melanie Bergeron, Fabio GarofoloAbstract: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.
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recommendations on the interpretation of the new european medicines agency guideline on Bioanalytical Method validation by global cro council for bioanalysis gcc
Bioanalysis, 2012Co-Authors: Mark Boterman, Steve Lowes, Fabio Garofolo, Ronald Shoup, Mira Doig, Massimo Breda, Jim Jersey, Isabelle Dumont, Suzanne Martinez, Shane NeedhamAbstract:Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA) and 5th GCC (14 November 2011, Barcelona, Spain) Closed Forums. These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified Bioanalytical recommendations specifically in relation with the new EMA guideline. The Global CRO Council for Bioanalysis (GCC) [101] is a global independent group of many Contract Research Organization (CRO) leaders. The GCC was formed in September 2010 to meet regularly and discuss Bioanalytical issues and regulatory challenges, many of them unique to the outsourcing industry. The outcome of the discussions held as part of these GCC closed forum meetings are shared with the global Bioanalytical community via pertinent publications [2–6] and appropriate conference presentations. Prior to the issue of this new guideline, the November 2009 Draft EMA Guideline on BMV defined the proposed guideline and criteria of the EMA on validation of Bioanalytical Methods and their application in the analysis of study samples from animal and human studies [7]. The EMA Guideline states that the validation of the Bioanalytical Methods to be used on non-clinical pharmacotoxicological studies to be submitted in a marketing authorization application should be performed following the Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
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matrix effect elimination during lc ms ms Bioanalytical Method development
Bioanalysis, 2009Co-Authors: Cynthia Cote, Annik Bergeron, Jeannicholas Mess, Milton Furtado, Fabio GarofoloAbstract:Due to the presence of endogenous components in biofluids, ionization suppression or enhancement may occur for Bioanalytical assays using LC–MS or LC–MS/MS technologies. The matrix effect may affect the precision and accuracy of a Bioanalytical Method and, therefore, compromise the quality of the results. Protein precipitation sample preparation along with LC–MS/MS is a high-throughput Method most commonly used in bioanalysis and is largely affected by the matrix effect. In order to eliminate the matrix effect during the Method development, some considerations may be used: cleaner sample preparations, more sensitive instruments, which allow less material to be injected, different chromatographic separations and much more must be investigated. More than giving tools to adequately assess the matrix effect during the Method development, this review gives scientists numerous ways to eliminate or reduce the matrix effect based on novel sample-preparation techniques, new chromatographic optimization Methods and...
Binodh Desilva - One of the best experts on this subject based on the ideXlab platform.
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Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
The AAPS Journal, 2015Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve LowesAbstract: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 .
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workshop report crystal city v quantitative Bioanalytical Method validation and implementation the 2013 revised fda guidance
Aaps Journal, 2015Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve LowesAbstract: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.
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Bioanalytical Method validation: concepts, expectations and challenges in small molecule and macromolecule--a report of PITTCON 2013 symposium.
Aaps Journal, 2014Co-Authors: Edward D. Bashaw, Binodh Desilva, Mark J. Rose, Yow-ming C. Wang, Chinmay G. ShuklaAbstract: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.
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Bioanalytical Method requirements and statistical considerations in incurred sample reanalysis for macromolecules
Bioanalysis, 2010Co-Authors: Theingi M. Thway, Chris Macaraeg, Dominador Calamba, Laura Brunner, Michael Eschenberg, Ramak Pourvasei, Liana Zhang, Binodh DesilvaAbstract:Background: Incurred sample reanalysis (ISR) is the most recent in-study validation parameter that regulatory agencies have mandated to ensure reproducibility of Bioanalytical Methods supporting pharmacokinetic/toxicokinetic and clinical studies. The present analysis describes five representative case studies for macromolecule therapeutics. Method: Single ISR acceptance criteria (within 30% of the averaged or original concentration) and a modified Bland–Altman (BA) approach were used to assess accuracy and precision of ISR results. General concordance between the two criteria was examined using simulation studies. Results: All five Methods met the ISR criteria. The results indicated that thorough Method development and prestudy validation were prerequisites for a successful ISR. The overall agreement between the original and reanalyzed results as determined by BA was within 20%. Simulation studies indicated that concordance between the ISR criteria and BA was observed in 95% of the cases. Dilution factors...
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key elements of Bioanalytical Method validation for macromolecules
Aaps Journal, 2007Co-Authors: Marian Kelley, Binodh DesilvaAbstract:The Third American Association of Pharmaceutical Scientists/US Food and Drug Administration (FDA) Bioanalytical Workshop, which was held May 1 and 2, 2006, in Arlington, VA, addressed Bioanalytical assays that are being used for the quantification of therapeutic candidates in support of pharmacokinetic evaluations. One of the main goals of this workshop was to discuss best practices used in bioanalysis regardless of the size of the therapeutic candidates. Since the last Bioanalytical workshop, technological advancements in the field and in the statistical understanding of the validation issues have generated a variety of interpretations to clarify and understand the practicality of using the current FDA guidance for assaying macromolecular therapeutics. This article addresses some of the key elements that are essential to the validation of macromolecular therapeutics using ligand binding assays. Because of the nature of ligand binding assays, attempts have been made within the scientific community to use statistical approaches to interpret the acceptance criteria that are aligned with the prestudy validation and in-study validation (sample analysis) processes. We discuss, among other topics, using the total error criterion or confidence interval approaches for acceptance of assays and using anchor calibrators to fit the nonlinear regression models.
Roger Hayes - One of the best experts on this subject based on the ideXlab platform.
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gcc consolidated feedback to ich on the 2019 ich m10 Bioanalytical Method validation draft guideline
Bioanalysis, 2019Co-Authors: Corey Nehls, Stephanie Cape, Michael H Buonarati, Rafiq Islam, Christina Satterwhite, Chad Briscoe, Roger Hayes, Andrew Dinan, Kurt Sales, Shelby AndersonAbstract: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...
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8th gcc consolidated feedback to us fda on the 2013 draft fda guidance on Bioanalytical Method validation
Bioanalysis, 2014Co-Authors: Joseph Bower, Dominique Gouty, Steve Lowes, Richard Lelacheur, Fabio Garofolo, Roger Hayes, Douglas Fast, Robert Nicholson, Jennifer Bravo, Ronald ShoupAbstract: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.
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evaluation of automated micro solid phase extraction tips μ spe for the validation of a lc ms ms Bioanalytical Method
Journal of Chromatography B, 2006Co-Authors: Jim X Shen, Cristina I Tama, Roger HayesAbstract:Abstract Automated μ-SPE tips were successfully utilized for the determination of posaconazole in rat plasma. The Bioanalytical Method using μ-SPE tips was successfully qualified for routine quantitation of posaconazole over the concentration range of 10.0–10,000 ng/mL in rat EDTA plasma. Inter-assay precision, based on percent relative deviation for n = 18 replicate quality controls, was ≤5.7%. Inter-assay accuracy based on n = 18 replicate quality controls was ±7.7%. Complete solid phase extraction using μ-SPE tips was demonstrated on a Tomtec liquid handler where >95% recovery for posaconazole was obtained. The μ-SPE tips had sufficient capacity to extract at least 100 μL plasma fortified with 10 μg/mL of posaconazole and the analyte could be efficiently eluted with as little as 60 μL of methanol. Of particular note is the unique ability of these μ-SPE tips to perform exhaustive solid phase extraction more commonly performed when using liquid/liquid extraction.
Brian Booth - One of the best experts on this subject based on the ideXlab platform.
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workshop report crystal city vi Bioanalytical Method validation for biomarkers
Aaps Journal, 2016Co-Authors: Mark E Arnold, Brian Booth, Lindsay KingAbstract:With the growing focus on translational research and the use of biomarkers to drive drug development and approvals, biomarkers have become a significant area of research within the pharmaceutical industry. However, until the US Food and Drug Administration’s (FDA) 2013 draft guidance on Bioanalytical Method validation included consideration of biomarker assays using LC-MS and LBA, those assays were created, validated, and used without standards of performance. This lack of expectations resulted in the FDA receiving data from assays of varying quality in support of efficacy and safety claims. The AAPS Crystal City VI (CC VI) Workshop in 2015 was held as the first forum for industry-FDA discussion around the general issues of biomarker measurements (e.g., endogenous levels) and specific technology strengths and weaknesses. The 2-day workshop served to develop a common understanding among the industrial scientific community of the issues around biomarkers, informed the FDA of the current state of the science, and will serve as a basis for further dialogue as experience with biomarkers expands with both groups.
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Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
The AAPS Journal, 2015Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve LowesAbstract: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 .
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workshop report crystal city v quantitative Bioanalytical Method validation and implementation the 2013 revised fda guidance
Aaps Journal, 2015Co-Authors: Brian Booth, Binodh Desilva, Mark E Arnold, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve LowesAbstract: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.
