2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance (Q82623280)

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17 January 2020

title

2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance (English)

1 reference

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17 January 2020

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance (English)

1 reference

3 September 2024

1 reference

21

Joleen T White

1 reference

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17 January 2020

author name string

Natasha Savoie

1

1 reference

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17 January 2020

Fabio Garofolo

2

1 reference

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17 January 2020

Peter van Amsterdam

3

1 reference

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17 January 2020

Surendra Bansal

4

1 reference

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17 January 2020

Chris Beaver

5

1 reference

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17 January 2020

Patrick Bedford

6

1 reference

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17 January 2020

Christopher Evans

8

1 reference

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17 January 2020

Mohammed Jemal

9

1 reference

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17 January 2020

Marc Lefebvre

10

1 reference

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17 January 2020

Arthur Leonardo Lopes de Silva

11

1 reference

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17 January 2020

Steve Lowes

12

1 reference

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17 January 2020

Robert Massé

14

1 reference

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17 January 2020

Louise Mawer

15

1 reference

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17 January 2020

Eric Ormsby

16

1 reference

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17 January 2020

Ct Viswanathan

18

1 reference

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17 January 2020

Jason Wakelin-Smith

19

1 reference

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17 January 2020

Jan Welink

20

1 reference

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17 January 2020

Eric Woolf

22

1 reference

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17 January 2020

Brian P. Booth

7

1 reference

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3 September 2024

Joseph C. Marini

13

1 reference

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3 September 2024

Mario L. Rocci

17

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3 September 2024

language of work or name

English

1 reference

National Center for Biotechnology Information

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/esummary.fcgi?db=pubmed&retmode=json&id=21110739

3 September 2024

publication date

1 December 2010

1 reference

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17 January 2020

1 reference

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17 January 2020

volume

2

1 reference

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17 January 2020

issue

12

1 reference

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17 January 2020

page(s)

1945-1960

1 reference

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Workshop report and follow-up--AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples--implications of Crystal City recommendations

17 January 2020

cites work

1 reference

24 May 2022

https://opencitations.net/index/coci/api/v1/citations/10.1208/S12248-009-9100-9

Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum

1 reference

24 May 2022

https://opencitations.net/index/coci/api/v1/citations/10.4155/BIO.09.108

Society Spotlight: Spotlight on the Calibration and Validation Group

1

1 reference

The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis

3 September 2024

2

1 reference

2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

3 September 2024

3

1 reference

Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

3 September 2024

8

1 reference

Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules

3 September 2024

10

1 reference

Bioanalytical Method Validation: Notable Points in The 2009 Draft EMA Guideline and Differences with The 2001 FDA Guidance

3 September 2024

13

1 reference

European Bioanalysis Forum and the Way Forward Towards Harmonized Regulations

3 September 2024

20

1 reference

Towards Harmonized Regulations for Bioanalysis: Moving Forward!

3 September 2024

21

1 reference

International harmonization of bioanalytical guidance.

3 September 2024

22

1 reference

Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis

3 September 2024

23

1 reference

Mass spectrometric quantitation of peptides and proteins using Stable Isotope Standards and Capture by Anti-Peptide Antibodies (SISCAPA).

3 September 2024

32

1 reference

A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation

3 September 2024

33

1 reference

Critical ligand binding reagent preparation/selection: when specificity depends on reagents

3 September 2024

34

1 reference

3 September 2024

Identifiers

DOI

10.4155/BIO.10.164

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:21110739%20AND%20SRC:MED&resulttype=core&format=json

17 January 2020

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