Validation in Proteomics and Regulatory Affairs

J. Silberring, M. Wojtkiewicz, Pawel S Ciborowski

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Experimental design principles for achieving validity and efficiency are required for any multi-variable experiment. In this chapter we attempt to review validation principles applicable to complex high-throughput experiments such as proteomic profiling. Typical proteomic study consists of a string of multiple steps each of which can be validated by different orthogonal methods. Nevertheless, all steps will have an impact on the overall outcome, providing answers of biological importance. As much as validation of analytical methods is quite well established, validation of experimental design or bioinformatics analysis is still in its infancy. We also discuss the validation of proteomic profiling experiments from the perspective of regulatory affairs.

Original languageEnglish (US)
Title of host publicationProteomic Profiling and Analytical Chemistry
Subtitle of host publicationThe Crossroads: Second Edition
PublisherElsevier Inc.
Pages253-271
Number of pages19
ISBN (Print)9780444636881
DOIs
StatePublished - Mar 22 2016

Fingerprint

Design of experiments
Experiments
Bioinformatics
Throughput
Proteomics

Keywords

  • Bioinformatics
  • Cross-validation
  • Detection level
  • Instrument validation
  • Precision
  • Regulation
  • Reproducibility
  • Sample loss
  • Validation, Accuracy

ASJC Scopus subject areas

  • Chemistry(all)

Cite this

Silberring, J., Wojtkiewicz, M., & Ciborowski, P. S. (2016). Validation in Proteomics and Regulatory Affairs. In Proteomic Profiling and Analytical Chemistry: The Crossroads: Second Edition (pp. 253-271). Elsevier Inc.. https://doi.org/10.1016/B978-0-444-63688-1.00014-8

Validation in Proteomics and Regulatory Affairs. / Silberring, J.; Wojtkiewicz, M.; Ciborowski, Pawel S.

Proteomic Profiling and Analytical Chemistry: The Crossroads: Second Edition. Elsevier Inc., 2016. p. 253-271.

Research output: Chapter in Book/Report/Conference proceedingChapter

Silberring, J, Wojtkiewicz, M & Ciborowski, PS 2016, Validation in Proteomics and Regulatory Affairs. in Proteomic Profiling and Analytical Chemistry: The Crossroads: Second Edition. Elsevier Inc., pp. 253-271. https://doi.org/10.1016/B978-0-444-63688-1.00014-8
Silberring J, Wojtkiewicz M, Ciborowski PS. Validation in Proteomics and Regulatory Affairs. In Proteomic Profiling and Analytical Chemistry: The Crossroads: Second Edition. Elsevier Inc. 2016. p. 253-271 https://doi.org/10.1016/B978-0-444-63688-1.00014-8
Silberring, J. ; Wojtkiewicz, M. ; Ciborowski, Pawel S. / Validation in Proteomics and Regulatory Affairs. Proteomic Profiling and Analytical Chemistry: The Crossroads: Second Edition. Elsevier Inc., 2016. pp. 253-271
@inbook{6063f7442c384b41872c917ab50be215,
title = "Validation in Proteomics and Regulatory Affairs",
abstract = "Experimental design principles for achieving validity and efficiency are required for any multi-variable experiment. In this chapter we attempt to review validation principles applicable to complex high-throughput experiments such as proteomic profiling. Typical proteomic study consists of a string of multiple steps each of which can be validated by different orthogonal methods. Nevertheless, all steps will have an impact on the overall outcome, providing answers of biological importance. As much as validation of analytical methods is quite well established, validation of experimental design or bioinformatics analysis is still in its infancy. We also discuss the validation of proteomic profiling experiments from the perspective of regulatory affairs.",
keywords = "Bioinformatics, Cross-validation, Detection level, Instrument validation, Precision, Regulation, Reproducibility, Sample loss, Validation, Accuracy",
author = "J. Silberring and M. Wojtkiewicz and Ciborowski, {Pawel S}",
year = "2016",
month = "3",
day = "22",
doi = "10.1016/B978-0-444-63688-1.00014-8",
language = "English (US)",
isbn = "9780444636881",
pages = "253--271",
booktitle = "Proteomic Profiling and Analytical Chemistry",
publisher = "Elsevier Inc.",

}

TY - CHAP

T1 - Validation in Proteomics and Regulatory Affairs

AU - Silberring, J.

AU - Wojtkiewicz, M.

AU - Ciborowski, Pawel S

PY - 2016/3/22

Y1 - 2016/3/22

N2 - Experimental design principles for achieving validity and efficiency are required for any multi-variable experiment. In this chapter we attempt to review validation principles applicable to complex high-throughput experiments such as proteomic profiling. Typical proteomic study consists of a string of multiple steps each of which can be validated by different orthogonal methods. Nevertheless, all steps will have an impact on the overall outcome, providing answers of biological importance. As much as validation of analytical methods is quite well established, validation of experimental design or bioinformatics analysis is still in its infancy. We also discuss the validation of proteomic profiling experiments from the perspective of regulatory affairs.

AB - Experimental design principles for achieving validity and efficiency are required for any multi-variable experiment. In this chapter we attempt to review validation principles applicable to complex high-throughput experiments such as proteomic profiling. Typical proteomic study consists of a string of multiple steps each of which can be validated by different orthogonal methods. Nevertheless, all steps will have an impact on the overall outcome, providing answers of biological importance. As much as validation of analytical methods is quite well established, validation of experimental design or bioinformatics analysis is still in its infancy. We also discuss the validation of proteomic profiling experiments from the perspective of regulatory affairs.

KW - Bioinformatics

KW - Cross-validation

KW - Detection level

KW - Instrument validation

KW - Precision

KW - Regulation

KW - Reproducibility

KW - Sample loss

KW - Validation, Accuracy

UR - http://www.scopus.com/inward/record.url?scp=84969704586&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84969704586&partnerID=8YFLogxK

U2 - 10.1016/B978-0-444-63688-1.00014-8

DO - 10.1016/B978-0-444-63688-1.00014-8

M3 - Chapter

AN - SCOPUS:84969704586

SN - 9780444636881

SP - 253

EP - 271

BT - Proteomic Profiling and Analytical Chemistry

PB - Elsevier Inc.

ER -