Detalhe da pesquisa
1.
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
Clin Pharmacol Ther
; 112(1): 31-43, 2022 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-34358334
2.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 14(9): 505-580, 2022 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-35578993
3.
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - 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).
Bioanalysis
; 13(4): 203-238, 2021 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-33470871
4.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 13(5): 295-361, 2021 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-33511867
5.
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.
Clin Pharmacol Ther
; 108(5): 949-963, 2020 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-31958142
6.
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Bioanalysis
; 11(23): 2099-2132, 2019 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-31833782
7.
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Bioanalysis
; 10(23): 1897-1917, 2018 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488729
8.
2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Bioanalysis
; 9(23): 1895-1912, 2017 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-29205053
9.
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
Bioanalysis
; 9(22): 1807-1825, 2017 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-29148835
10.
Conduct of remote inspections: challenges and progress.
Bioanalysis
; 13(24): 1789-1791, 2021 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-34786951
11.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).
Bioanalysis
; 8(23): 2457-2474, 2016 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-27855509
12.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).
Bioanalysis
; 7(23): 3019-34, 2015 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-26627049
13.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).
Bioanalysis
; 7(22): 2913-25, 2015.
Artigo
em Inglês
| MEDLINE | ID: mdl-26573485
14.
Variations in internal standard: an inspector's perspective.
Bioanalysis
; 11(18): 1649-1651, 2019 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-31617397
15.
Crucial importance of evaluating internal standards (IS) response and troubleshooting in effective LCMS method development, validation and sample analysis.
Bioanalysis
; 11(18): 1645-1647, 2019 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-31637924