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.
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
4.
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
5.
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
6.
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
7.
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
8.
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
Resultados
1 -
8
de 8
1
Próxima >
>>