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Results: 1 to 20 of 120

1.

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.

PMID:
23484783
[PubMed - indexed for MEDLINE]
Free Article
2.

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
[PubMed - indexed for MEDLINE]
3.

Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).

Boterman M, Doig M, Breda M, Lowes S, Jersey J, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Cruz Caturla M, Couerbe P, Guittard J, Maltas J, Lansing T, Bhatti M, Schiebl C, Struwe P, Sheldon C, Hayes R, Sangster T, Pattison C, Bouchard J, Goodwin L, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Zimmer D, Folguera L, Zimmermann T, Pawula M, Moussallie M, Teixeira Lde S, Rocha T, Tang D, Jardieu P, Truog J, Lin J, Lundberg R, Cox C, Breau A, Bigogno C, Schoutsen D, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Nicholson R, Jenkins R, Lin MH, Karnik S, De Boer T, Houghton R, Green R, DeMaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Malone M, Best S, Fang X.

Bioanalysis. 2012 Mar;4(6):651-60. doi: 10.4155/bio.12.18. No abstract available.

PMID:
22452256
[PubMed - indexed for MEDLINE]
Free Article
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.

PMID:
22303826
[PubMed - indexed for MEDLINE]
Free Article
5.

Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum.

Timmerman P, Luedtke S, van Amsterdam P, Brudny-Kloeppel M, Lausecker B, Fischmann S, Globig S, Sennbro CJ, Jansat JM, Mulder H, Thomas E, Knutsson M, Kasel D, White SA, Kall MA, Mokrzycki-Issartel N, Freisleben A, Romero F, Andersen MP, Knebel N, de Zwart M, Laakso S, Hucker RS, Schmidt D, Gordon B, Abbott R, Boulanger P.

Bioanalysis. 2009 Sep;1(6):1049-56. doi: 10.4155/bio.09.108.

PMID:
21083073
[PubMed - indexed for MEDLINE]
Free Article
6.

Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum.

Timmerman P, Anders Kall M, Gordon B, Laakso S, Freisleben A, Hucker R.

Bioanalysis. 2010 Jul;2(7):1185-94. doi: 10.4155/bio.10.90.

PMID:
21083233
[PubMed - indexed for MEDLINE]
Free Article
7.

4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

Lowes S, Jersey J, Shoup R, Garofolo F, Needham S, Couerbe P, Lansing T, Bhatti M, Sheldon C, Hayes R, Islam R, Lin Z, Garofolo W, Moussallie M, Teixeira Lde S, Rocha T, Jardieu P, Truog J, Lin J, Lundberg R, Breau A, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Jenkins R, Nicholson R, Lin MH, Karnik S, DeMaio W, Smith K, Cojocaru L, Allen M, Fatmi S, Sayyarpour F, Malone M, Fang X.

Bioanalysis. 2012 Apr;4(7):763-8. doi: 10.4155/bio.12.48.

PMID:
22512795
[PubMed - indexed for MEDLINE]
Free Article
8.

Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays.

Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R.

Pharm Res. 2007 Oct;24(10):1962-73. Epub 2007 Apr 26.

PMID:
17458684
[PubMed - indexed for MEDLINE]
9.

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
[PubMed - indexed for MEDLINE]
10.

Workshop report and follow-up--AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples--implications of Crystal City recommendations.

Fast DM, Kelley M, Viswanathan CT, O'Shaughnessy J, King SP, Chaudhary A, Weiner R, DeStefano AJ, Tang D.

AAPS J. 2009 Jun;11(2):238-41. doi: 10.1208/s12248-009-9100-9. Epub 2009 Apr 21. Review.

PMID:
19381839
[PubMed - indexed for MEDLINE]
Free PMC Article
11.

From challenges to solutions. European Bioanalysis Forum 3rd Annual Open Symposium, Hesperia Towers, Barcelona, Spain, 1-3 December 2010.

Abbott RW, Gordon B, van Amsterdam P, Lausecker B, Brudny-Kloeppel M, Smeraglia J, Romero F, Globig S, Golob M, Knutsson M, Herling C, Vieser E, Timmerman P.

Bioanalysis. 2011 Apr;3(8):833-8. doi: 10.4155/bio.11.52.

PMID:
21510756
[PubMed - indexed for MEDLINE]
Free Article
12.

European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development.

Timmerman P, Herling C, Stoellner D, Jaitner B, Pihl S, Elsby K, Henderson N, Barroso B, Fischmann S, Companjen A, Versteilen A, Bates S, Kingsley C, Kunz U; European Bioanalysis Forum.

Bioanalysis. 2012 Aug;4(15):1883-94. doi: 10.4155/bio.12.164.

PMID:
22943619
[PubMed - indexed for MEDLINE]
Free Article
13.

EBF recommendation on the validation of bioanalytical methods for dried blood spots.

Timmerman P, White S, Globig S, Lüdtke S, Brunet L, Smeraglia J.

Bioanalysis. 2011 Jul;3(14):1567-75. doi: 10.4155/bio.11.132. Epub 2011 Jul 12.

PMID:
21749218
[PubMed - indexed for MEDLINE]
Free Article
14.

Conference report: AAPS and US FDA Crystal City V meeting on Quantitative Bioanalytical Method Validation and Implementation: feedback from the EBF.

Smeraglia J, McDougall S, Elsby K, Companjen A, White S, Golob M, Brudny-Kloeppel M, Amsterdam Pv, Timmerman P.

Bioanalysis. 2014 Mar;6(6):729-32. doi: 10.4155/bio.14.17.

PMID:
24702107
[PubMed - in process]
Free Article
15.

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
[PubMed - indexed for MEDLINE]
16.

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.

PMID:
21942519
[PubMed - indexed for MEDLINE]
Free Article
17.

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.

PMID:
21083184
[PubMed - indexed for MEDLINE]
Free Article
18.

Managing scientific, technical and regulatory innovation in regulated bioanalysis: a discussion paper from the European Bioanalysis Forum.

Timmerman P, Henderson N, Smeraglia J, Mulder H, Ingelse B, Brudny-Kloeppel M, Companjen A.

Bioanalysis. 2013 Jan;5(2):139-45. doi: 10.4155/bio.12.267.

PMID:
23330557
[PubMed - indexed for MEDLINE]
19.

2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.

Savoie N, Garofolo F, van Amsterdam P, Bansal S, Beaver C, Bedford P, Booth BP, Evans C, Jemal M, Lefebvre M, Lopes de Silva AL, Lowes S, Marini JC, Massé R, Mawer L, Ormsby E, Rocci ML Jr, Viswanathan C, Wakelin-Smith J, Welink J, White JT, Woolf E.

Bioanalysis. 2010 Dec;2(12):1945-60. doi: 10.4155/bio.10.164.

PMID:
21110739
[PubMed - indexed for MEDLINE]
Free Article
20.

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

DeSilva B, Garofolo F, Rocci M, Martinez S, Dumont I, Landry F, Dicaire C, Szekely-Klepser G, Weiner R, Arnold M, Bansal S, Bateman K, Bauer R, Booth B, Davis S, Dudal S, Gouty D, Grundy J, Haidar S, Hayes R, Jemal M, Kaur S, Kelley M, Knutsson M, Le Blaye O, Lee J, Lowes S, Ma M, Mitsuoka T, Neto JT, Nicholson R, Ormsby E, Sailstad J, Stevenson L, Tang D, Welink J, Viswanathan CT, Wang L, Woolf E, Yang E.

Bioanalysis. 2012 Sep;4(18):2213-26. doi: 10.4155/bio.12.205.

PMID:
23046264
[PubMed - indexed for MEDLINE]
Free Article

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