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PubPharm (11)
1
2019 White Paper On Recent Issues in Bioanalysis : FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (
enthalten in:
Bioanalysis
| 2019
von
Booth, B.
|
Stevenson, L.
|
Pillutla, R.
| +50
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2
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
enthalten in:
Bioanalysis
| 2019
von
Nehls, C.
|
Buonarati, M.
|
Cape, S.
| +62
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3
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
enthalten in:
Bioanalysis
| 2019
von
Islam, R.
|
Kar, S.
|
Ritzén, H.
| +60
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4
Assessing stability in bioanalysis : reflections on the last 10 years
enthalten in:
Bioanalysis
| 2019
von
Briscoe, C.
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5
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
enthalten in:
Bioanalysis
| 2018
von
Islam, R.
|
Briscoe, C.
|
Bower, J.
| +68
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6
2017 White Paper on recent issues in bioanalysis : aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers)
enthalten in:
Bioanalysis
| 2017
von
Welink, J.
|
Yang, E.
|
Hughes, N.
| +43
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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
enthalten in:
Bioanalysis
| 2017
von
Cape, S.
|
Islam, R.
|
Nehls, C.
| +66
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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
enthalten in:
Bioanalysis
| 2016
von
Hayes, R.
|
LeLacheur, R.
|
Dumont, I.
| +57
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9
8th GCC : consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation
enthalten in:
Bioanalysis
| 2014
von
Bower, J.
|
Fast, D.
|
Garofolo, F.
| +60
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10
New setting for the Land O'Lakes Bioanalytical Conference
enthalten in:
Bioanalysis
| 2013
von
DeMuth, J.
|
Ho, S.
|
Briscoe, C.
| +4
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Thema: Biomarkers
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11
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11
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biomarker
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