Abstract

In recent years biomarker assays have gained precedence both in the clinical and pharmaceutical laboratory. In the pharmaceutical arena biomarkers play multifaceted roles in the safety and efficacy studies of drug development. Alternatively, in the clinic, biomarker assays are useful in screening, diagnosis, detection, prognosis and prediction of diseases and disorders. The bio analytical validation of biomarker assays has been a topic of wide interest. The major bottle neck in this area is the paucity of a fixed regulatory guidance. The various phases in the development of new biomarker assays are pre-analytical considerations, analytical considerations and biomarker assay implementation. The focus of this review has been to address in detail the pre-analytical and analytical considerations in the development of new biomarker assays in a well-known matrix like dried blood spots both in the pharmaceutical and clinical laboratory. The validation parameters discussed include specificity, sensitivity, matrix effect, precision, accuracy, linearity, dilution linearity, parallelism, carry over, proficiency testing and reference intervals. Additional parameters for dried blood spot assays include hematocrit, blood spot volume, chromatographic effect, spot to spot carry over and DBS vs whole blood/plasma concentration.

Original languageEnglish
Pages (from-to)4031-4038
Number of pages8
JournalResearch Journal of Pharmacy and Technology
Volume12
Issue number8
DOIs
Publication statusPublished - 01-08-2019

Fingerprint

Biomarkers
Pharmaceutical Preparations
Blood Volume
Hematocrit
Safety
Sensitivity and Specificity

All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Pharmacology (medical)

Cite this

@article{adc3949452ab40689ff95b59b0106604,
title = "Analytical validation strategies for dbs biomarker assays",
abstract = "In recent years biomarker assays have gained precedence both in the clinical and pharmaceutical laboratory. In the pharmaceutical arena biomarkers play multifaceted roles in the safety and efficacy studies of drug development. Alternatively, in the clinic, biomarker assays are useful in screening, diagnosis, detection, prognosis and prediction of diseases and disorders. The bio analytical validation of biomarker assays has been a topic of wide interest. The major bottle neck in this area is the paucity of a fixed regulatory guidance. The various phases in the development of new biomarker assays are pre-analytical considerations, analytical considerations and biomarker assay implementation. The focus of this review has been to address in detail the pre-analytical and analytical considerations in the development of new biomarker assays in a well-known matrix like dried blood spots both in the pharmaceutical and clinical laboratory. The validation parameters discussed include specificity, sensitivity, matrix effect, precision, accuracy, linearity, dilution linearity, parallelism, carry over, proficiency testing and reference intervals. Additional parameters for dried blood spot assays include hematocrit, blood spot volume, chromatographic effect, spot to spot carry over and DBS vs whole blood/plasma concentration.",
author = "Mathew, {Elizabeth Mary} and Pragna Rao and Raghavendra Shetty and Leslie Lewis and Sudheer Moorkoth",
year = "2019",
month = "8",
day = "1",
doi = "10.5958/0974-360X.2019.00695.4",
language = "English",
volume = "12",
pages = "4031--4038",
journal = "Research Journal of Pharmacy and Technology",
issn = "0974-3618",
publisher = "A and V Publication",
number = "8",

}

Analytical validation strategies for dbs biomarker assays. / Mathew, Elizabeth Mary; Rao, Pragna; Shetty, Raghavendra; Lewis, Leslie; Moorkoth, Sudheer.

In: Research Journal of Pharmacy and Technology, Vol. 12, No. 8, 01.08.2019, p. 4031-4038.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Analytical validation strategies for dbs biomarker assays

AU - Mathew, Elizabeth Mary

AU - Rao, Pragna

AU - Shetty, Raghavendra

AU - Lewis, Leslie

AU - Moorkoth, Sudheer

PY - 2019/8/1

Y1 - 2019/8/1

N2 - In recent years biomarker assays have gained precedence both in the clinical and pharmaceutical laboratory. In the pharmaceutical arena biomarkers play multifaceted roles in the safety and efficacy studies of drug development. Alternatively, in the clinic, biomarker assays are useful in screening, diagnosis, detection, prognosis and prediction of diseases and disorders. The bio analytical validation of biomarker assays has been a topic of wide interest. The major bottle neck in this area is the paucity of a fixed regulatory guidance. The various phases in the development of new biomarker assays are pre-analytical considerations, analytical considerations and biomarker assay implementation. The focus of this review has been to address in detail the pre-analytical and analytical considerations in the development of new biomarker assays in a well-known matrix like dried blood spots both in the pharmaceutical and clinical laboratory. The validation parameters discussed include specificity, sensitivity, matrix effect, precision, accuracy, linearity, dilution linearity, parallelism, carry over, proficiency testing and reference intervals. Additional parameters for dried blood spot assays include hematocrit, blood spot volume, chromatographic effect, spot to spot carry over and DBS vs whole blood/plasma concentration.

AB - In recent years biomarker assays have gained precedence both in the clinical and pharmaceutical laboratory. In the pharmaceutical arena biomarkers play multifaceted roles in the safety and efficacy studies of drug development. Alternatively, in the clinic, biomarker assays are useful in screening, diagnosis, detection, prognosis and prediction of diseases and disorders. The bio analytical validation of biomarker assays has been a topic of wide interest. The major bottle neck in this area is the paucity of a fixed regulatory guidance. The various phases in the development of new biomarker assays are pre-analytical considerations, analytical considerations and biomarker assay implementation. The focus of this review has been to address in detail the pre-analytical and analytical considerations in the development of new biomarker assays in a well-known matrix like dried blood spots both in the pharmaceutical and clinical laboratory. The validation parameters discussed include specificity, sensitivity, matrix effect, precision, accuracy, linearity, dilution linearity, parallelism, carry over, proficiency testing and reference intervals. Additional parameters for dried blood spot assays include hematocrit, blood spot volume, chromatographic effect, spot to spot carry over and DBS vs whole blood/plasma concentration.

UR - http://www.scopus.com/inward/record.url?scp=85074150189&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85074150189&partnerID=8YFLogxK

U2 - 10.5958/0974-360X.2019.00695.4

DO - 10.5958/0974-360X.2019.00695.4

M3 - Article

AN - SCOPUS:85074150189

VL - 12

SP - 4031

EP - 4038

JO - Research Journal of Pharmacy and Technology

JF - Research Journal of Pharmacy and Technology

SN - 0974-3618

IS - 8

ER -