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The AAPS Journal
|
March 12, 2025
Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis
Faye Vazvaei-Smith, Wenkui Li, Omar S Barnaby, et al.
Molecular & Cellular Proteomics : MCP
|
April 27, 2023
Meeting Report on the 2nd Chinese American Society for Mass Spectrometry Conference: Advancing Biological and Pharmaceutical Mass Spectrometry
Yue Chen, Ying Ge, Xianlin Han, et al.
Bioanalysis
|
November 18, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS)
Jan Welink, Eric Fluhler, Nicola Hughes, et al.
Bioanalysis
|
September 28, 2011
2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections
Fabio Garofolo, Mario L Rocci, Isabelle Dumont, et al.
Bioanalysis
|
October 8, 2016
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)
Eric Yang, Jan Welink, Stephanie Cape, et al.
Bioanalysis
|
November 18, 2017
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers)
Jan Welink, Eric Yang, Nicola Hughes, et al.
Bioanalysis
|
January 20, 2021
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (<u>Part 1</u> - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)
Hendrik Neubert, Stephen C Alley, Anita Lee, et al.
Bioanalysis
|
January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (<u>Part 1A</u> - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV)
John Wojcik, Timothy Sikorski, Jian Wang, et al.
Bioanalysis
|
August 31, 2023
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (<u>Part 1A</u> - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
Matt Szapacs, Wenying Jian, Daniel Spellman, et al.
Bioanalysis
|
June 24, 2024
2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody <u>(PART 1A</u> - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis <u>PART 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
Mike Baratta, Wenying Jian, Shawna Hengel, et al.
Page
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Search research articles
Search
Showing results (91-100 of 100) with videos related to
Sort By:
Page
of 10
You have reached the last page of results.
This site can display upto 100 results.
The AAPS Journal
|
March 12, 2025
Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis
Faye Vazvaei-Smith, Wenkui Li, Omar S Barnaby, et al.
Molecular & Cellular Proteomics : MCP
|
April 27, 2023
Meeting Report on the 2nd Chinese American Society for Mass Spectrometry Conference: Advancing Biological and Pharmaceutical Mass Spectrometry
Yue Chen, Ying Ge, Xianlin Han, et al.
Bioanalysis
|
November 18, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS)
Jan Welink, Eric Fluhler, Nicola Hughes, et al.
Bioanalysis
|
September 28, 2011
2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections
Fabio Garofolo, Mario L Rocci, Isabelle Dumont, et al.
Bioanalysis
|
October 8, 2016
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)
Eric Yang, Jan Welink, Stephanie Cape, et al.
Bioanalysis
|
November 18, 2017
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers)
Jan Welink, Eric Yang, Nicola Hughes, et al.
Bioanalysis
|
January 20, 2021
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (<u>Part 1</u> - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)
Hendrik Neubert, Stephen C Alley, Anita Lee, et al.
Bioanalysis
|
January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (<u>Part 1A</u> - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV)
John Wojcik, Timothy Sikorski, Jian Wang, et al.
Bioanalysis
|
August 31, 2023
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (<u>Part 1A</u> - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
Matt Szapacs, Wenying Jian, Daniel Spellman, et al.
Bioanalysis
|
June 24, 2024
2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody <u>(PART 1A</u> - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis <u>PART 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
Mike Baratta, Wenying Jian, Shawna Hengel, et al.
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