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1 .
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)
저자
by
Brian Booth
;
Lauren Stevenson
;
Renuka Pillutla
;
Michael Buonarati
;
Chris Beaver
, et al.
소스
Bioanalysis
. 11:2099-2132
Open Access (OpenAIRE)
Web of Science
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7 .
Special Focus Issue - COVID-19: bioanalytical considerations, contributions and lessons - part 2
저자
by
Matthew Barfield
;
Chad Briscoe
.
소스
Bioanalysis
. 13(24)
Scopus
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4 .
Assessing stability in bioanalysis: reflections on the last 10 years
저자
by
Chad Briscoe
.
소스
Bioanalysis
. 11:579-582
Open Access (OpenAIRE)
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3 .
Stability issues in bioanalysis
저자
by
Chad Briscoe
;
Rafiq Islam
.
소스
Bioanalysis
. 11(20)
Open Access (OpenAIRE)
Scopus
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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
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7 .
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
저자
by
Xinping Fang
;
Cheikh Kane
;
Valentine Barra
;
Dawn Dufield
;
Marsha Luna
, et al.
소스
Bioanalysis
. 11(18s)
Open Access (OpenAIRE)
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7 .
Contract research organization commentary on the importance of harmonization and the impact of ICH M10
저자
by
Chad Briscoe
;
Mike Buonarati
;
Christina Satterwhite
;
Stephanie Cape
;
Rafiq Islam
, et al.
소스
Bioanalysis
. 11(18)
Open Access (OpenAIRE)
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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)
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