NDLI: Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling

Please wait, while we are loading the content...

A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution

Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

Study Reanalysis Using a Mechanism-Based Pharmacokinetic/Pharmacodynamic Model of Pramlintide in Subjects with Type 1 Diabetes

Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Renal Organic Anion Transporters (SLC22 Family): Expression, Regulation, Roles in Toxicity, and Impact on Injury and Disease

Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes

Interactions of Everolimus and Sorafenib in Pancreatic Cancer Cells

Biodegradable Particles as Vaccine Delivery Systems: Size Matters

How Promiscuous Are Pharmaceutically Relevant Compounds? A Data-Driven Assessment

Determination of the Dominant Arachidonic Acid Cytochrome P450 Monooxygenases in Rat Heart, Lung, Kidney, and Liver: Protein Expression and Metabolite Kinetics

Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling

Amino-Terminated Generation 2 Poly(amidoamine) Dendrimer as a Potential Broad-Spectrum, Nonresistance-Inducing Antibacterial Agent

A Pharmacokinetic Simulation Tool for Inhaled Corticosteroids

The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics

Target-Mediated Disposition Model Describing the Dynamics of IL12 and IFNγ after Administration of a Mifepristone-Inducible Adenoviral Vector for IL-12 Expression in Mice

Therapeutic Roles of Curcumin: Lessons Learned from Clinical Trials

Supersaturated Self-Nanoemulsifying Drug Delivery Systems (Super-SNEDDS) Enhance the Bioavailability of the Poorly Water-Soluble Drug Simvastatin in Dogs

Integrated Pharmacokinetic-Driven Approach to Screen Candidate Anticancer Drugs for Brain Tumor Chemotherapy

A Novel Beads-Based Dissolution Method for the In Vitro Evaluation of Extended Release HPMC Matrix Tablets and the Correlation with the In Vivo Data

Mechanistic Models Describing Active Renal Reabsorption and Secretion: A Simulation-Based Study

Year: 2012, Volume: 15

Year: 2012, Volume: 14

Year: 2011, Volume: 14

Year: 2011, Volume: 13

Year: 2010, Volume: 13

Year: 2010, Volume: 12

Year: 2009, Volume: 12

Year: 2009, Volume: 11

Year: 2008, Volume: 10

Year: 2007, Volume: 9

Year: 2006, Volume: 8

Year: 2005, Volume: 7

Year: 2004, Volume: 6

Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling

Content Provider	PubMed Central
Author	Burns, Daniel Brunner, Laura Rajendran, Surendran Johnson, Beth Mark, Ma Wang, Jin
Abstract	Dried blood spots (DBS) technology has been introduced as a microsampling alternative to traditional plasma or serum sampling for pharmacokinetics or toxicokinetics evaluation. The application of DBS has been established for many small molecule drugs at discovery, nonclinical, and clinical stages. However, the application of DBS for large molecule therapeutics development is not yet well-established. This article describes the method validation of a ligand binding assay (LBA) for DBS sampling of a therapeutic monoclonal antibody—AMG 162 (Denosumab). The original serum LBA was modified for the DBS method. A fit-for-purpose method validation was performed to evaluate accuracy and precision, selectivity, dilutional linearity, and stability. In addition, the parameters relevant to DBS, such as spot volume, extraction recovery, whole blood stability, and hematocrit effects, were evaluated. The validation results demonstrated assay robustness with inter-assay precision of ≤19%, inter-assay accuracy of ≤9%, and total error of ≤24%. Selectivity, extraction recovery, dilutional linearity, and stability were demonstrated. The validation results revealed some limitations of the possible effect of blood hematocrit on therapeutic concentration measurements and the caution required using whole blood for standards and quality controls preparation. This is the first article to describe a thorough method validation of an LBA using DBS for a therapeutic monoclonal antibody. The lessons learned can serve as a model process for future method validation of other LBAs for large molecule therapeutics or biomarkers using the DBS sampling method.
Related Links	http://dx.doi.org/10.1208/s12248-012-9430-x
Ending Page	131
Page Count	9
Starting Page	123
File Format	PDF
ISSN	15507416
e-ISSN	15507416
Journal	The AAPS Journal
Issue Number	1
Volume Number	15
Language	English
Publisher	Springer US
Publisher Date	2013-01-01
Access Restriction	Open
Rights Holder	Springer US
Subject Keyword	Research in Higher Education
Content Type	Text
Resource Type	Article
Subject	Pharmaceutical Science

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling

Validation and Application of a Dried Blood Spot Ceftriaxone Assay

Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group

Validation and Application of a Dried Blood Spot Ceftriaxone Assay

Development and validation of a dried blood spot assay for the quantification of ribavirin using liquid chromatography coupled to mass spectrometry

Evaluation of Dried Blood Spot Testing for SARS-CoV-2 Serology Using a Quantitative Commercial Assay

Development and Validation of a Dried Serum/Blood Spot Combined Enzyme-Linked Immunosorbent Assay for the Analysis of Anticitrullinated Protein Antibodies: A New Rheumatoid Arthritis Biomarker Platform

Using Dried Blood Spot Sampling to Improve Data Quality and Reduce Animal Use in Mouse Pharmacokinetic Studies

Blood and Dried Blood Spot Telomere Length Measurement by qPCR: Assay Considerations

Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling

Similar Documents

Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling

Validation and Application of a Dried Blood Spot Ceftriaxone Assay

Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group

Validation and Application of a Dried Blood Spot Ceftriaxone Assay

Development and validation of a dried blood spot assay for the quantification of ribavirin using liquid chromatography coupled to mass spectrometry

Evaluation of Dried Blood Spot Testing for SARS-CoV-2 Serology Using a Quantitative Commercial Assay

Development and Validation of a Dried Serum/Blood Spot Combined Enzyme-Linked Immunosorbent Assay for the Analysis of Anticitrullinated Protein Antibodies: A New Rheumatoid Arthritis Biomarker Platform

Using Dried Blood Spot Sampling to Improve Data Quality and Reduce Animal Use in Mouse Pharmacokinetic Studies

Blood and Dried Blood Spot Telomere Length Measurement by qPCR: Assay Considerations

Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling