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1.
Size and macromolecule stabilizer-dependent performance of gold colloids in immuno-PCR.
Anal Bioanal Chem;
414(6): 2205-2217, 2022 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-35034157
2.
Expression of root-related transcription factors associated with flooding tolerance of soybean (Glycine max).
Int J Mol Sci;
15(10): 17622-43, 2014 Sep 29.
Artículo
en Inglés
| MEDLINE | ID: mdl-25268626
3.
Recommendations on qPCR/ddPCR assay validation by GCC.
Bioanalysis;
14(12): 853-863, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35703321
4.
Recommendations on ELISpot assay validation by the GCC.
Bioanalysis;
14(4): 187-193, 2022 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-35135309
5.
Applications of gold nanoparticles in ELISA, PCR, and immuno-PCR assays: A review.
Anal Chim Acta;
1143: 250-266, 2021 Jan 25.
Artículo
en Inglés
| MEDLINE | ID: mdl-33384122
6.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-33847160
7.
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Bioanalysis;
11(7): 645-653, 2019 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-30993999
8.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-31319683
9.
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Bioanalysis;
11(18s): 1-228, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31565956
10.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-31833782
11.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Bioanalysis;
10(24): 1973-2001, 2018 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-30488726
12.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-29701066
13.
Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories.
AAPS J;
24(2): 36, 2022 02 22.
Artículo
en Inglés
| MEDLINE | ID: mdl-35194700
14.
Correction: Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories.
AAPS J;
24(3): 55, 2022 Apr 19.
Artículo
en Inglés
| MEDLINE | ID: mdl-35438454
15.
Characterization and performance of anodic mixed culture biofilms in submersed microbial fuel cells.
Bioelectrochemistry;
113: 79-84, 2017 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-27816024
16.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-28339299
17.
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Bioanalysis;
9(24): 1967-1996, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-29205064
18.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-29148835
19.
Remote audits: a CRO virtual reality - what lessons have been learned in a time of unexpected isolation.
Bioanalysis;
13(15): 1173-1176, 2021 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-34289737
20.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-26916197