Bioanalytical method validation and its implications for forensic and clinical toxicology — A review

Bioanalytical method validation and its implications for forensic and clinical toxicology - A review

Accreditation and Quality Assurance ◽

10.1007/s00769-002-0516-5 ◽

2002 ◽

Vol 7 (11) ◽

pp. 441-449 ◽

Cited By ~ 171

Author(s):

Frank T. Peters ◽

Hans H. Maurer

Keyword(s):

Method Validation ◽

Clinical Toxicology ◽

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 ◽

Lights and Shadows of the Actual European Guidelines on Bioanalytical Method Validation

Therapeutic Drug Monitoring ◽

10.1097/ftd.0000000000000083 ◽

2014 ◽

Vol 36 (6) ◽

pp. 739-745 ◽

Cited By ~ 4

Author(s):

Sara Baldelli ◽

Dario Cattaneo ◽

Serena Fucile ◽

Emilio Clementi

Keyword(s):

Method Validation ◽

Bioanalytical Method ◽

European Guidelines

Development and bioanalytical method validation of an LC-MS/MS assay for simultaneous quantitation of 2-alkyl-4(1H)-quinolones for application in bacterial cell culture and lung tissue

Analytical and Bioanalytical Chemistry ◽

10.1007/s00216-019-02374-0 ◽

2020 ◽

Vol 412 (7) ◽

pp. 1521-1534 ◽

Cited By ~ 4

Author(s):

Luke K. Brewer ◽

Jace W. Jones ◽

Catherine B. Blackwood ◽

Mariette Barbier ◽

Amanda Oglesby-Sherrouse ◽

...

Keyword(s):

Cell Culture ◽

Method Validation ◽

Lung Tissue ◽

Bacterial Cell ◽

Perspectives on updates, clarifications and controversies in chromatographic assay guidance for bioanalytical method validation from major regulatory agencies and organizations

Biomedical Chromatography ◽

10.1002/bmc.5030 ◽

2020 ◽

Vol 35 (1) ◽

Author(s):

Kris King ◽

Pei Li ◽

Alicia Pietrasiewicz ◽

Stanley Goldstein

Keyword(s):

Method Validation ◽

Regulatory Agencies ◽