Detalles de la búsqueda
1.
Recommendations on qPCR/ddPCR assay validation by GCC.
Bioanalysis
; 14(12): 853-863, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35703321
2.
Recommendations on ELISpot assay validation by the GCC.
Bioanalysis
; 14(4): 187-193, 2022 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-35135309
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.
Artículo
en Inglés
| 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.
Artículo
en Inglés
| MEDLINE | ID: mdl-33511867
5.
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
6.
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
7.
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
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-30993999
9.
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
10.
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
11.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-27855512
12.
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
13.
Contract research organization commentary on the importance of harmonization and the impact of ICH M10.
Bioanalysis
; 11(18): 1727-1729, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31556330
14.
Combined administration of RG7652, a recombinant human monoclonal antibody against PCSK9, and atorvastatin does not result in reduction of immune function.
Toxicol Sci
; 140(2): 470-80, 2014 Aug 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-24848798
15.
ClC-3 is a fundamental molecular component of volume-sensitive outwardly rectifying Cl- channels and volume regulation in HeLa cells and Xenopus laevis oocytes.
J Biol Chem
; 277(42): 40066-74, 2002 Oct 18.
Artículo
en Inglés
| MEDLINE | ID: mdl-12183454
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