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1.
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
2.
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
3.
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Bioanalysis
; 6(22): 2957-63, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-25496252
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