Detalhe da pesquisa
1.
Recommendations on ELISpot assay validation by the GCC.
Bioanalysis
; 14(4): 187-193, 2022 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-35135309
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.
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Bioanalysis
; 13(8): 609-619, 2021 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-33847160
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.
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bioanalysis
; 13(6): 415-463, 2021 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-33533276
6.
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
7.
2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 - Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis).
Bioanalysis
; 11(22): 2029-2048, 2019 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-31808716
8.
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Bioanalysis
; 11(7): 645-653, 2019 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-30993999
9.
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Bioanalysis
; 11(12): 1129-1138, 2019 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-31319683
10.
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Bioanalysis
; 11(18s): 1-228, 2019 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-31565956
11.
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
12.
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Bioanalysis
; 10(22): 1781-1801, 2018 Nov 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488725
13.
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
14.
11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Bioanalysis
; 10(7): 433-444, 2018 Apr 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-29701066
15.
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
Bioanalysis
; 9(7): 505-516, 2017 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-28339299
16.
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
17.
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
18.
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
Bioanalysis
; 8(6): 487-95, 2016 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-26916197
19.
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
20.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Bioanalysis
; 8(23): 2475-2496, 2016 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-27855512