352 related articles for article (PubMed ID: 22533559)
1. European Medicines Agency guideline on bioanalytical method validation: what more is there to say?
Smith G
Bioanalysis; 2012 May; 4(8):865-8. PubMed ID: 22533559
[No Abstract] [Full Text] [Related]
2. Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance.
Smith G
Bioanalysis; 2010 May; 2(5):929-35. PubMed ID: 21083222
[No Abstract] [Full Text] [Related]
3. 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. PubMed ID: 22512795
[TBL] [Abstract][Full Text] [Related]
4. Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?
Kaza M; Karaźniewicz-Łada M; Kosicka K; Siemiątkowska A; Rudzki PJ
J Pharm Biomed Anal; 2019 Feb; 165():381-385. PubMed ID: 30590335
[TBL] [Abstract][Full Text] [Related]
5. Is the bioanalytical community ready to revise the use of certain validation concepts and nomenclature?
Olsson AO; Liljeblad M; Nilsson LB; Silvester S
Bioanalysis; 2012 Jul; 4(14):1705-8. PubMed ID: 22877214
[No Abstract] [Full Text] [Related]
6. Review of the 2008 European Medicines Agency concept paper on bioanalytical method validation.
Smith G
Bioanalysis; 2009 Aug; 1(5):877-81. PubMed ID: 21083057
[No Abstract] [Full Text] [Related]
7. 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. PubMed ID: 22943622
[TBL] [Abstract][Full Text] [Related]
8. Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry.
Kadian N; Raju KS; Rashid M; Malik MY; Taneja I; Wahajuddin M
J Pharm Biomed Anal; 2016 Jul; 126():83-97. PubMed ID: 27179186
[TBL] [Abstract][Full Text] [Related]
9. Building the Global Bioanalysis Consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation.
van Amsterdam P; Arnold M; Bansal S; Fast D; Garofolo F; Lowes S; Timmerman P; Woolf E
Bioanalysis; 2010 Nov; 2(11):1801-3. PubMed ID: 21083486
[No Abstract] [Full Text] [Related]
10. Request for global harmonization of the guidance for Bioanalytical Method Validation and sample analysis.
Timmerman P; Lowes S; Fast DM; Garofolo F
Bioanalysis; 2010 Apr; 2(4):683. PubMed ID: 21083261
[No Abstract] [Full Text] [Related]
11. 8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Bower J; Fast D; Garofolo F; Gouty D; Hayes R; Lowes S; Nicholson R; LeLacheur R; Bravo J; Shoup R; Dumont I; Carbone M; Zimmer J; Ortuno J; Caturla MC; Datin J; Lansing T; Fatmi S; Struwe P; Sheldon C; Islam R; Yu M; Hulse J; Kamerud J; Lin J; Doughty J; Kurylak K; Tang D; Buonarati M; Blanchette A; Levesque A; Gagnon-Carignan S; Lin J; Ray G; Liu Y; Khan M; Xu A; El-Sulayman G; DiMarco C; Bouhajib M; Tacey D; Jenkins R; der Strate Bv; Briscoe C; Karnik S; Rhyne P; Garofolo W; Schultz G; Roberts A; Redrup M; DuBey I; Conliffe P; Pekol T; Hantash J; Cojocaru L; Allen M; Reuschel S; Watson A; Farrell C; Groeber E; Malone M; Nowatzke W; Fang X
Bioanalysis; 2014; 6(22):2957-63. PubMed ID: 25496252
[TBL] [Abstract][Full Text] [Related]
12. Justifying the lack of incurred sample reproducibility in a study: considerations and strategies.
Gagnon-Carignan S; Lachance S; Saint-Laurent A; Gendron M; Lévesque A
Bioanalysis; 2015; 7(2):221-7. PubMed ID: 25587838
[TBL] [Abstract][Full Text] [Related]
13. 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; 55(4):848-58. PubMed ID: 21237607
[TBL] [Abstract][Full Text] [Related]
14. The potential impact of laboratory informatics on technology transfer.
McDowall RD
Bioanalysis; 2015; 7(7):801-6. PubMed ID: 25932514
[No Abstract] [Full Text] [Related]
15. Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays.
Imazato-Hirano M; Taniguchi Y; Kakehi M; Kuze Y; Nakamura T; Minamide Y; Miya K; Hosogi J; Katashima M; Maekawa K; Okuda H; Niimi S; Kawasaki N; Ishii-Watabe A; Katori N
Bioanalysis; 2015; 7(9):1151-6. PubMed ID: 26039811
[No Abstract] [Full Text] [Related]
16. Cost-effective and business-beneficial computer validation for bioanalytical laboratories.
McDowall R
Bioanalysis; 2011 Jul; 3(13):1487-99. PubMed ID: 21728773
[TBL] [Abstract][Full Text] [Related]
17. Comparison of various international guidelines for analytical method validation.
Chandran S; Singh RS
Pharmazie; 2007 Jan; 62(1):4-14. PubMed ID: 17294806
[TBL] [Abstract][Full Text] [Related]
18. Increasing productivity in regulated bioanalytical laboratories: maximizing the use of resources.
Mann E; Smith G; Hill H
Bioanalysis; 2013 Jul; 5(13):1605-7. PubMed ID: 23822122
[No Abstract] [Full Text] [Related]
19. EPA's GLP compliance review of chemistry laboratories.
Hill DF
Qual Assur; 1993; 2(1-2):78-84. PubMed ID: 8156226
[TBL] [Abstract][Full Text] [Related]
20. Critical considerations into the new EMA guideline on bioequivalence.
Marzo A; Fontana E
Arzneimittelforschung; 2011; 61(4):207-20. PubMed ID: 21650079
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
