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1 .
Recommendations on qPCR/ddPCR assay validation by GCC
저자
by
Mark Wissel
;
Martin Poirier
;
Christina Satterwhite
;
John Lin
;
Rafiq Islam
, et al.
소스
Bioanalysis
. 14(12)
Scopus
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7 .
Recommendations on ELISpot assay validation by the GCC
저자
by
Rafiq Islam
;
Jennifer Vance
;
Martin Poirier
;
Jennifer Zimmer
;
Ardeshir Khadang
, et al.
소스
Bioanalysis
. 14(4)
Scopus
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7 .
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis
저자
by
Stacie McCown
;
Dave Williams
;
Esme Farley
;
Jennifer Zimmer
;
Mark O'Dell
, et al.
소스
Bioanalysis
. 13(8)
Scopus
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7 .
Looking beyond the WRIB Decennial Index of the White Papers in Bioanalysis
저자
by
Natasha Savoie
;
Wei Garofolo
.
소스
Bioanalysis
. 11:563-565
Open Access (OpenAIRE)
Web of Science
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4 .
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
저자
by
Andrea Wakefield
;
Barry van der Strate
;
Elizabeth Groeber
;
Saadya Fatmi
;
Jing Tu
, et al.
소스
Bioanalysis
. 9:505-516
Open Access (OpenAIRE)
Web of Science
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7 .
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
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by
Xinping Fang
;
Cheikh Kane
;
Valentine Barra
;
Dawn Dufield
;
Marsha Luna
, et al.
소스
Bioanalysis
. 11(18s)
Open Access (OpenAIRE)
Scopus
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7 .
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity
저자
by
Ira DuBey
;
Marc Moussallie
;
Nadia Kulagina
;
Dave Williams
;
Corey Nehls
, et al.
소스
Bioanalysis
. 11(12)
Open Access (OpenAIRE)
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7 .
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
저자
by
Mathilde Yu
;
Michele Malone
;
John Stamatopoulos
;
Christina Satterwhite
;
George Hristopoulos
, et al.
소스
Bioanalysis
. 11(7)
Open Access (OpenAIRE)
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7 .
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
저자
by
Ardeshir Khadang
;
Elizabeth Groeber
;
Gunjan Soni
;
Yi Qun Xiao
;
Afshin Safavi
, et al.
소스
Bioanalysis
. 8:487-495
Open Access (OpenAIRE)
Web of Science
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7 .
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
저자
by
Franklin Spriggs
;
Chris Beaver
;
Ashley Brant
;
Daniel Sikkema
;
Susan Ohorodnik
, et al.
소스
Bioanalysis
. 10(7)
Open Access (OpenAIRE)
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