198 related articles for article (PubMed ID: 8833963)
1. Issues in evaluation of bioanalytical method selectivity and drug stability.
Dadgar D; Burnett PE
J Pharm Biomed Anal; 1995 Dec; 14(1-2):23-31. PubMed ID: 8833963
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. Statistical methods for assessing long-term analyte stability in biological matrices.
Hoffman D; Kringle R; Singer J; McDougall S
J Chromatogr B Analyt Technol Biomed Life Sci; 2009 Aug; 877(23):2262-9. PubMed ID: 18789775
[TBL] [Abstract][Full Text] [Related]
4. Acceptance criteria for method equivalency assessments.
Chatfield MJ; Borman PJ
Anal Chem; 2009 Dec; 81(24):9841-8. PubMed ID: 19925004
[TBL] [Abstract][Full Text] [Related]
5. Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples.
Nowatzke W; Woolf E
AAPS J; 2007 Apr; 9(2):E117-22. PubMed ID: 17614353
[TBL] [Abstract][Full Text] [Related]
6. Evaluation of an isochronic study design for long-term frozen stability investigation of drugs in biological matrices.
Pihl S; Huusom AK; Rohde M; Poulsen MN; Jørgensen M; Kall MA
Bioanalysis; 2010 Jun; 2(6):1041-9. PubMed ID: 21083207
[TBL] [Abstract][Full Text] [Related]
7. Consideration on a few aspects of the stability studies post licensure.
Pierard I; Spelte G; Le Tallec D; Duchêne M
Biologicals; 2009 Nov; 37(6):403-6; discussion 421-3. PubMed ID: 19853472
[TBL] [Abstract][Full Text] [Related]
8. A strategy for a post-method-validation use of incurred biological samples for establishing the acceptability of a liquid chromatography/tandem mass-spectrometric method for quantitation of drugs in biological samples.
Jemal M; Ouyang Z; Powell ML
Rapid Commun Mass Spectrom; 2002; 16(16):1538-47. PubMed ID: 12203245
[TBL] [Abstract][Full Text] [Related]
9. Validation in pharmaceutical analysis. Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data.
Ermer J; Ploss HJ
J Pharm Biomed Anal; 2005 Apr; 37(5):859-70. PubMed ID: 15862659
[TBL] [Abstract][Full Text] [Related]
10. [The evaluation of non-isothermal short-term tests of drug solutions].
Kersten D; Göber B
Pharmazie; 1984 Aug; 39(8):541-6. PubMed ID: 6504977
[TBL] [Abstract][Full Text] [Related]
11. Probability of passing dissolution acceptance criteria for an immediate release tablet.
Dumont ML; Berry MR; Nickerson B
J Pharm Biomed Anal; 2007 May; 44(1):79-84. PubMed ID: 17379465
[TBL] [Abstract][Full Text] [Related]
12. Application of an acceptance sampling plan for post-production quality control of chemotherapeutic batches in an hospital pharmacy.
Borget I; Laville I; Paci A; Michiels S; Mercier L; Desmaris RP; Bourget P
Eur J Pharm Biopharm; 2006 Aug; 64(1):92-8. PubMed ID: 16750352
[TBL] [Abstract][Full Text] [Related]
13. Overview of stability study designs.
Lin TY; Chen CW
J Biopharm Stat; 2003 Aug; 13(3):337-54. PubMed ID: 12921386
[TBL] [Abstract][Full Text] [Related]
14. 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]
15. Bioanalytical considerations for compounds containing free sulfhydryl groups.
Srinivas NR; Mamidi RN
Biomed Chromatogr; 2003 Jul; 17(5):285-91. PubMed ID: 12884392
[TBL] [Abstract][Full Text] [Related]
16. Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics.
Lee JW
Bioanalysis; 2009 Nov; 1(8):1461-74. PubMed ID: 21083095
[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. Validation of direct assay of an aqueous formulation of a drug compound AZY by chiral supercritical fluid chromatography (SFC).
Mukherjee PS
J Pharm Biomed Anal; 2007 Jan; 43(2):464-70. PubMed ID: 16930907
[TBL] [Abstract][Full Text] [Related]
19. Goals of stability evaluation throughout the vaccine life cycle.
Krause PR
Biologicals; 2009 Nov; 37(6):369-78; discussion 421-3. PubMed ID: 19775911
[TBL] [Abstract][Full Text] [Related]
20. Design and analysis of method equivalence studies.
Borman PJ; Chatfield MJ; Damjanov I; Jackson P
Anal Chem; 2009 Dec; 81(24):9849-57. PubMed ID: 19925005
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
