Format
Sort by
Items per page

Send to

Choose Destination

Links from PubMed

Items: 1 to 20 of 193

1.

Capsule review on bioanalytical method transfer: opportunities and challenges for chromatographic methods.

Lin ZJ, Li W, Weng N.

Bioanalysis. 2011 Jan;3(1):57-66. doi: 10.4155/bio.10.168. Review.

PMID:
21175367
2.

Regulatory considerations for development of bioanalytical assays for biotechnology products.

Swann PG, Shapiro MA.

Bioanalysis. 2011 Mar;3(6):597-603. doi: 10.4155/bio.11.27.

PMID:
21417729
3.

Methodologies for the transfer of analytical methods: a review.

Rozet E, Dewé W, Ziemons E, Bouklouze A, Boulanger B, Hubert P.

J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Aug 1;877(23):2214-23. doi: 10.1016/j.jchromb.2008.12.049. Epub 2008 Dec 25. Review.

PMID:
19144574
4.

US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium.

Garofolo F, Michon J, Leclaire V, Booth B, Lowes S, Viswanathan CT, Welink J, Haidar S, Teixeira Lde S, Tang D, Desilva B.

Bioanalysis. 2012 Feb;4(3):231-6. doi: 10.4155/bio.12.1.

5.

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
6.

A proposed "fixed" range decision criteria for transfer of bioanalytical methods.

Shah KA, Karnes HT.

J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Aug 1;877(23):2270-4. doi: 10.1016/j.jchromb.2009.04.020. Epub 2009 Apr 17.

PMID:
19411196
7.

Fit-for-purpose bioanalytical cross-validation for LC-MS/MS assays in clinical studies.

Xu X, Ji QC, Jemal M, Gleason C, Shen JX, Stouffer B, Arnold ME.

Bioanalysis. 2013 Jan;5(1):83-90. doi: 10.4155/bio.12.291.

PMID:
23256474
8.

Method transfer for ligand-binding assays: recommendations for best practice.

DeSimone D, Shih JY, Gunn HC, Patel V, Uy L, Thway TM.

Bioanalysis. 2011 Sep;3(18):2143-52. doi: 10.4155/bio.11.199. Review.

PMID:
21942524
9.

Historical perspective on the development and evolution of bioanalytical guidance and technology.

Shah VP, Bansal S.

Bioanalysis. 2011 Apr;3(8):823-7. doi: 10.4155/bio.11.45.

PMID:
21510754
10.

Workshop/conference report on EMA draft guideline on validation of bioanalytical methods.

Blume H, Brendel E, Brudny-Klöppel M, Grebe S, Lausecker B, Rohde G, Siethoff C.

Eur J Pharm Sci. 2011 Feb 14;42(3):300-5. doi: 10.1016/j.ejps.2010.12.008. Epub 2010 Dec 24.

PMID:
21185936
11.

Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management.

Huang Y, Shi R, Gee W, Bonderud R.

Bioanalysis. 2012 Aug;4(15):1919-31. doi: 10.4155/bio.12.157. Review.

PMID:
22943622
12.

Risk-based approach for the transfer of quantitative methods: bioanalytical applications.

Rozet E, Dewé W, Morello R, Chiap P, Lecomte F, Ziemons E, Boos KS, Boulanger B, Crommen J, Hubert P.

J Chromatogr A. 2008 May 2;1189(1-2):32-41. Epub 2007 Nov 17.

PMID:
18068176
13.

Method transfer, partial validation, and cross validation: recommendations for best practices and harmonization from the global bioanalysis consortium harmonization team.

Briggs RJ, Nicholson R, Vazvaei F, Busch J, Mabuchi M, Mahesh KS, Brudny-Kloeppel M, Weng N, Galvinas PA, Duchene P, Hu P, Abbott RW.

AAPS J. 2014 Nov;16(6):1143-8. doi: 10.1208/s12248-014-9650-3. Epub 2014 Sep 5.

14.

Validation of bioanalytical chromatographic methods.

Hartmann C, Smeyers-Verbeke J, Massart DL, McDowall RD.

J Pharm Biomed Anal. 1998 Jun;17(2):193-218. Review.

PMID:
9638572
15.

Global bioanalytical support.

John Lin Z, Zhang T, Pasas-Farmer S, Brooks SD, Moyer M, Connolly R.

Bioanalysis. 2014 May;6(10):1349-56. doi: 10.4155/bio.14.101.

PMID:
24958119
16.

The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation.

van Amsterdam P, Companjen A, Brudny-Kloeppel M, Golob M, Luedtke S, Timmerman P.

Bioanalysis. 2013 Mar;5(6):645-59. doi: 10.4155/bio.13.19.

17.

New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR.

Zimmer D.

Bioanalysis. 2014 Jan;6(1):13-9. doi: 10.4155/bio.13.298. Epub 2013 Nov 20. No abstract available.

PMID:
24256335
18.

The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis.

Savoie N, Booth BP, Bradley T, Garofolo F, Hughes NC, Hussain S, King SP, Lindsay M, Lowes S, Ormsby E, Phull R, Rocci ML Jr, Vallano PT, Viau A, Zhu Z.

Bioanalysis. 2009 Apr;1(1):19-30. doi: 10.4155/bio.09.11.

19.

Bioanalytical method development: considering information from a suite of complementary methods.

Fountain ME.

Bioanalysis. 2012 Jan;4(2):115-9. doi: 10.4155/bio.11.307. No abstract available.

20.

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

Garofolo F, Rocci ML Jr, Dumont I, Martinez S, Lowes S, Woolf E, van Amsterdam P, Bansal S, Barra AC, Bauer R, Booth BP, Carrasco-Triguero M, DeSilva B, Dunn J, Gallicano K, Gouty D, Ho S, Hucker R, Jemal M, Katori N, Le Blaye O, Lee J, Li W, Michael S, Nehls C, Nicholson R, Ormsby E, Tang D, Viswanathan CT, Weiner R, Young G.

Bioanalysis. 2011 Sep;3(18):2081-96. doi: 10.4155/bio.11.192.

Supplemental Content

Support Center