Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays

Bioanalytical Method ◽

Regulatory Guideline

Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

Pharmaceutical Research ◽

10.1023/b:pham.0000003390.51761.3d ◽

2003 ◽

Vol 20 (11) ◽

pp. 1885-1900 ◽

Cited By ~ 447

Author(s):

Binodh DeSilva ◽

Wendell Smith ◽

Russell Weiner ◽

Marian Kelley ◽

JoMarie Smolec ◽

...

Keyword(s):

Ligand Binding ◽

Method Validation ◽

Binding Assays ◽

Review of Recommendations for Bioanalytical Method Validation: Chromatographic Assays and Ligand Binding Assays

Chromatographia ◽

10.1007/s10337-018-3677-z ◽

2018 ◽

Vol 82 (2) ◽

pp. 523-535

Author(s):

Vaishali Londhe ◽

Madhura Rajadhyaksha

Keyword(s):

Ligand Binding ◽

Method Validation ◽

Binding Assays ◽

Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments

Bioanalysis ◽

10.4155/bio-2017-0044 ◽

2017 ◽

Vol 9 (18) ◽

pp. 1407-1422 ◽

Cited By ~ 3

Author(s):

Rebecca G Watson ◽

Adrienne Clements-Egan ◽

Allen Schantz ◽

Mark Ware ◽

Bonnie Wu ◽

...

Keyword(s):

Ligand Binding ◽

Method Validation ◽

Binding Assay ◽

Large Molecule ◽

Ligand Binding Assay ◽

Bioanalytical Method ◽

Tiered Approach ◽

Assay Methods

Calculations for Adjusting Endogenous Biomarker Levels During Analytical Recovery Assessments for Ligand-Binding Assay Bioanalytical Method Validation

The AAPS Journal ◽

10.1208/s12248-015-9756-2 ◽

2015 ◽

Vol 17 (4) ◽

pp. 939-947 ◽

Cited By ~ 5

Author(s):

John F. Marcelletti ◽

Cindy L. Evans ◽

Manju Saxena ◽

Adriana E. Lopez

Keyword(s):

Ligand Binding ◽

Method Validation ◽

Binding Assay ◽

Ligand Binding Assay ◽

Bioanalytical Method ◽

Analytical Recovery

Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance

Bioanalysis ◽

10.4155/bio.10.42 ◽

2010 ◽

Vol 2 (5) ◽

pp. 929-935 ◽

Cited By ~ 34

Author(s):

Graeme Smith

Keyword(s):

Method Validation ◽

Bioanalytical Method ◽

Fda Guidance

The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation

The AAPS Journal ◽

10.1208/aapsj0901005 ◽

2007 ◽

Vol 9 (1) ◽

pp. E43-E47 ◽

Cited By ~ 80

Author(s):

Vinod P. Shah

Keyword(s):

Method Validation ◽

Bioanalytical Methods ◽

Guidance Document ◽

Bioanalytical Method ◽

History Of

Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation

The AAPS Journal ◽

10.1208/s12248-014-9566-y ◽

2014 ◽

Vol 16 (2) ◽

pp. 352-356 ◽

Cited By ~ 10

Author(s):

Joseph F. Bower ◽

Jennifer B. McClung ◽

Carl Watson ◽

Takahiko Osumi ◽

Kátia Pastre

Keyword(s):

Best Practices ◽

Method Validation ◽

Reference Standards ◽

Drug development and bioanalytical method validation for a novel anticancer molecule, 4‐(dimethylamino)‐2‐(p‐tolylamino) thiazole‐5‐carbonitrile

Drug Development Research ◽

10.1002/ddr.21462 ◽

2018 ◽

Vol 79 (8) ◽

pp. 391-399 ◽

Cited By ~ 6

Author(s):

Nripendra Madhab Biswas ◽

Amit Shard ◽

Sagarkumar Patel ◽

Pinaki Sengupta

Keyword(s):

Drug Development ◽

Method Validation ◽

Bioanalytical Method Validation and Quantification of Flupirtine in Canine Plasma by HPLC with Spectrofluorimetric Detection

American Journal of Animal and Veterinary Sciences ◽

10.3844/ajavsp.2015.91.100 ◽

2015 ◽

Vol 10 (2) ◽

pp. 91-100 ◽

Cited By ~ 3

Author(s):

Virginia De Vito ◽

Alessandro Saba ◽

Helen Owen ◽

Mario Giorgi

Keyword(s):

Method Validation ◽

Bioanalytical Method ◽

Validation And Quantification ◽

Spectrofluorimetric Detection ◽

Canine Plasma

Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies

Pharmaceutical Research ◽

10.1007/s11095-005-5917-9 ◽

2005 ◽

Vol 22 (9) ◽

pp. 1425-1431 ◽

Cited By ~ 75

Author(s):

JoMarie Smolec ◽

Binodh DeSilva ◽

Wendell Smith ◽

Russell Weiner ◽

Marian Kelly ◽

...

Keyword(s):

Method Validation ◽

Pharmacokinetic Studies ◽