234 related articles for article (PubMed ID: 21083262)
1. International harmonization of bioanalytical guidance.
Bansal SK; Arnold M; Garofolo F
Bioanalysis; 2010 Apr; 2(4):685-7. PubMed ID: 21083262
[No Abstract] [Full Text] [Related]
2. 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]
3. 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; Viswanathan C; Wakelin-Smith J; Welink J; White JT; Woolf E
Bioanalysis; 2010 Dec; 2(12):1945-60. PubMed ID: 21110739
[TBL] [Abstract][Full Text] [Related]
4. Incurred sample reanalysis: a global transformation.
Viswanathan CT
Bioanalysis; 2011 Dec; 3(23):2601-2. PubMed ID: 22136048
[TBL] [Abstract][Full Text] [Related]
5. 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]
6. Formation of a Global Contract Research Organization Council for Bioanalysis.
Premkumar N; Lowes S; Jersey J; Garofolo F; Dumont I; Masse R; Stamatiou B; Caturla MC; Steffen R; Malone M; Offman E; Samuels T; Oldfield P; Di Donato L; Fast D; Tang D; Moussallie M; Doughty J; Rocci M; Buonarati M; Gouty D; Dadgar D; Stamatopoulos J; Breau A; Ntsikoussalabongui B; Bouhajib M; Nicholson B; Tacey R; Ketelaar P; Briscoe C; Karnik S; Wieling J; Smith JK; Reid MJ; Lelacheur R; Chapdelaine J; Fatmi S; Sayyarpour F; Fang X; Cook J; Browne D
Bioanalysis; 2010 Nov; 2(11):1797-800. PubMed ID: 21083485
[No Abstract] [Full Text] [Related]
7. 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]
8. 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.
Savoie N; Garofolo F; van Amsterdam P; Booth BP; Fast DM; Lindsay M; Lowes S; Masse R; Mawer L; Ormsby E; Phull R; Rocci ML; Vallano PT; Yin X
Bioanalysis; 2010 Jan; 2(1):53-68. PubMed ID: 21083120
[TBL] [Abstract][Full Text] [Related]
9. [Technical implications on the quality standard of new drugs].
Uchiyama M
Eisei Shikenjo Hokoku; 1995; (113):135-6. PubMed ID: 8717247
[TBL] [Abstract][Full Text] [Related]
10. 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]
11. Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC).
Sangster T; Maltas J; Struwe P; Hillier J; Boterman M; Doig M; Breda M; Garofolo F; Caturla MC; Couerbe P; Schiebl C; Pattison C; Goodwin L; Segers R; Garofolo W; Folguera L; Zimmer D; Zimmerman T; Pawula M; Tang D; Cox C; Bigogno C; Schoutsen D; de Boer T; Green R; Houghton R; Sable R; Siethoff C; Harter T; Best S;
Bioanalysis; 2012 Jul; 4(14):1723-30. PubMed ID: 22877218
[No Abstract] [Full Text] [Related]
12. Key elements of bioanalytical method validation for small molecules.
Bansal S; DeStefano A
AAPS J; 2007 Mar; 9(1):E109-14. PubMed ID: 17408234
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. Regulatory observations in bioanalytical determinations.
Viswanathan CT
Bioanalysis; 2010 Jul; 2(7):1325-9. PubMed ID: 21083243
[TBL] [Abstract][Full Text] [Related]
15. Incurred sample reanalysis: dilemma in its applicability - should it be practiced for all bioanalytical assays involving single (parent or metabolite) or multiple analytes (parent/metabolite or parent with co-administered drugs)?
Srinivas NR
Biomed Chromatogr; 2011 Jun; 25(6):737-9. PubMed ID: 21465501
[No Abstract] [Full Text] [Related]
16. 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]
17. Regulated bioanalysis: an Indian perspective on harmonization efforts.
Ramanathan VK; Vachharajani NN
Bioanalysis; 2011 Apr; 3(7):713-6. PubMed ID: 21452987
[No Abstract] [Full Text] [Related]
18. Validating stability and selectivity in the presence of co-administered compounds.
DeChenne S; Yahvah K; Zimmer J
Bioanalysis; 2019 Oct; 11(20):1819-1821. PubMed ID: 31617389
[No Abstract] [Full Text] [Related]
19. Guidelines from the International Conference on Harmonisation (ICH).
Branch SK
J Pharm Biomed Anal; 2005 Aug; 38(5):798-805. PubMed ID: 16076542
[TBL] [Abstract][Full Text] [Related]
20. Pharmaceuticals and related drugs.
Gilpin RK; Gilpin CS
Anal Chem; 2007 Jun; 79(12):4275-93. PubMed ID: 17511425
[No Abstract] [Full Text] [Related]
[Next] [New Search]
