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Items: 1 to 20 of 88

1.

In Vivo Assay Guidelines.

Haas J, Manro J, Shannon H, Anderson W, Brozinick J, Chakravartty A, Chambers M, Du J, Eastwood B, Heuer J, Iturria S, Iversen P, Johnson D, Johnson K, O’Neill M, Qian HR, Sindelar D, Svensson K.

In: Sittampalam GS, Coussens NP, Brimacombe K, Grossman A, Arkin M, Auld D, Austin C, Baell J, Bejcek B, Chung TDY, Dahlin JL, Devanaryan V, Foley TL, Glicksman M, Hall MD, Hass JV, Inglese J, Iversen PW, Kahl SD, Kales SC, Lal-Nag M, Li Z, McGee J, McManus O, Riss T, Trask OJ Jr., Weidner JR, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-.
2012 May 1 [updated 2012 Oct 1].

2.

In vivo erythrocyte micronucleus assay III. Validation and regulatory acceptance of automated scoring and the use of rat peripheral blood reticulocytes, with discussion of non-hematopoietic target cells and a single dose-level limit test.

Hayashi M, MacGregor JT, Gatehouse DG, Blakey DH, Dertinger SD, Abramsson-Zetterberg L, Krishna G, Morita T, Russo A, Asano N, Suzuki H, Ohyama W, Gibson D; In Vivo Micronucleus Assay Working Group, IWGT.

Mutat Res. 2007 Feb 3;627(1):10-30. Epub 2006 Dec 6.

PMID:
17157053
3.

Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies.

Valentin MA, Ma S, Zhao A, Legay F, Avrameas A.

J Pharm Biomed Anal. 2011 Jul 15;55(5):869-77. doi: 10.1016/j.jpba.2011.03.033. Epub 2011 Mar 29.

PMID:
21530130
4.

Acceptance Probability (P a) Analysis for Process Validation Lifecycle Stages.

Alsmeyer D, Pazhayattil A, Chen S, Munaretto F, Hye M, Sanghvi P.

AAPS PharmSciTech. 2016 Apr;17(2):516-22. doi: 10.1208/s12249-015-0338-5. Epub 2015 May 30.

5.

Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.

DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, Khan M, Tacey R, Hill H, Celniker A.

Pharm Res. 2003 Nov;20(11):1885-900.

PMID:
14661937
6.

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.

Jani D, Allinson J, Berisha F, Cowan KJ, Devanarayan V, Gleason C, Jeromin A, Keller S, Khan MU, Nowatzke B, Rhyne P, Stephen L.

AAPS J. 2016 Jan;18(1):1-14. doi: 10.1208/s12248-015-9820-y. Epub 2015 Sep 16. Review.

7.

Conceptual and statistical issues in the validation of analytic dilution assays for pharmaceutical applications.

Smith WC, Sittampalam GS.

J Biopharm Stat. 1998 Nov;8(4):509-32. Review.

PMID:
9855031
8.

In vivo rodent erythrocyte micronucleus assay. II. Some aspects of protocol design including repeated treatments, integration with toxicity testing, and automated scoring.

Hayashi M, MacGregor JT, Gatehouse DG, Adler ID, Blakey DH, Dertinger SD, Krishna G, Morita T, Russo A, Sutou S.

Environ Mol Mutagen. 2000;35(3):234-52.

PMID:
10737958
9.

The discovery and development of proteomic safety biomarkers for the detection of drug-induced liver toxicity.

Amacher DE.

Toxicol Appl Pharmacol. 2010 May 15;245(1):134-42. doi: 10.1016/j.taap.2010.02.011. Epub 2010 Feb 26. Review.

PMID:
20219512
10.

HTS Assay Validation.

Iversen PW, Beck B, Chen YF, Dere W, Devanarayan V, Eastwood BJ, Farmen MW, Iturria SJ, Montrose C, Moore RA, Weidner JR, Sittampalam GS.

In: Sittampalam GS, Coussens NP, Brimacombe K, Grossman A, Arkin M, Auld D, Austin C, Baell J, Bejcek B, Chung TDY, Dahlin JL, Devanaryan V, Foley TL, Glicksman M, Hall MD, Hass JV, Inglese J, Iversen PW, Kahl SD, Kales SC, Lal-Nag M, Li Z, McGee J, McManus O, Riss T, Trask OJ Jr., Weidner JR, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-.
2012 May 1 [updated 2012 Oct 1].

11.

Advances in validation, risk and uncertainty assessment of bioanalytical methods.

Rozet E, Marini RD, Ziemons E, Boulanger B, Hubert P.

J Pharm Biomed Anal. 2011 Jun 25;55(4):848-58. doi: 10.1016/j.jpba.2010.12.018. Epub 2010 Dec 21.

PMID:
21237607
12.
13.

Fit-for-purpose biomarker immunoassay qualification and validation: three case studies.

Cowan K, Gao X, Parab V, Nguy T, Wu L, Arron JR, Townsend M, Wallin J, Cheu M, Morimoto A, Wakshull E.

Bioanalysis. 2016 Oct 7. [Epub ahead of print]

PMID:
27712082
14.

Validation of a HLA-A2 tetramer flow cytometric method, IFNgamma real time RT-PCR, and IFNgamma ELISPOT for detection of immunologic response to gp100 and MelanA/MART-1 in melanoma patients.

Xu Y, Theobald V, Sung C, DePalma K, Atwater L, Seiger K, Perricone MA, Richards SM.

J Transl Med. 2008 Oct 22;6:61. doi: 10.1186/1479-5876-6-61.

15.

Validation of soluble amyloid-β precursor protein assays as diagnostic CSF biomarkers for neurodegenerative diseases.

van Waalwijk van Doorn LJ, Koel-Simmelink MJ, Haußmann U, Klafki H, Struyfs H, Linning P, Knölker HJ, Twaalfhoven H, Kuiperij HB, Engelborghs S, Scheltens P, Verbeek MM, Vanmechelen E, Wiltfang J, Teunissen CE.

J Neurochem. 2016 Apr;137(1):112-21. doi: 10.1111/jnc.13527. Epub 2016 Jan 24.

16.

Single cell gel/comet assay: guidelines for in vitro and in vivo genetic toxicology testing.

Tice RR, Agurell E, Anderson D, Burlinson B, Hartmann A, Kobayashi H, Miyamae Y, Rojas E, Ryu JC, Sasaki YF.

Environ Mol Mutagen. 2000;35(3):206-21.

PMID:
10737956
17.

Translational Metabolomics of Head Injury: Exploring Dysfunctional Cerebral Metabolism with Ex Vivo NMR Spectroscopy-Based Metabolite Quantification.

Wolahan SM, Hirt D, Glenn TC.

In: Kobeissy FH, editor. Brain Neurotrauma: Molecular, Neuropsychological, and Rehabilitation Aspects. Boca Raton (FL): CRC Press/Taylor & Francis; 2015. Chapter 25.

18.

Risk-based Methodology for Validation of Pharmaceutical Batch Processes.

Wiles F.

PDA J Pharm Sci Technol. 2013 Jul-Aug;67(4):387-98. doi: 10.5731/pdajpst.2013.00923.

PMID:
23872447
19.

Targeted peptide measurements in biology and medicine: best practices for mass spectrometry-based assay development using a fit-for-purpose approach.

Carr SA, Abbatiello SE, Ackermann BL, Borchers C, Domon B, Deutsch EW, Grant RP, Hoofnagle AN, Hüttenhain R, Koomen JM, Liebler DC, Liu T, MacLean B, Mani DR, Mansfield E, Neubert H, Paulovich AG, Reiter L, Vitek O, Aebersold R, Anderson L, Bethem R, Blonder J, Boja E, Botelho J, Boyne M, Bradshaw RA, Burlingame AL, Chan D, Keshishian H, Kuhn E, Kinsinger C, Lee JS, Lee SW, Moritz R, Oses-Prieto J, Rifai N, Ritchie J, Rodriguez H, Srinivas PR, Townsend RR, Van Eyk J, Whiteley G, Wiita A, Weintraub S.

Mol Cell Proteomics. 2014 Mar;13(3):907-17. doi: 10.1074/mcp.M113.036095. Epub 2014 Jan 17.

20.

Recommendations for conducting the in vivo alkaline Comet assay. 4th International Comet Assay Workshop.

Hartmann A, Agurell E, Beevers C, Brendler-Schwaab S, Burlinson B, Clay P, Collins A, Smith A, Speit G, Thybaud V, Tice RR; 4th International Comet Assay Workshop.

Mutagenesis. 2003 Jan;18(1):45-51.

PMID:
12473734

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