-
3
-
-
84988175795
-
Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies
-
Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD, Pittman KA, Spector S (1992) Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci 81: 309-312.
-
(1992)
J Pharm Sci
, vol.81
, pp. 309-312
-
-
Shah, V.P.1
Midha, K.K.2
Dighe, S.3
McGilveray, I.J.4
Skelly, J.P.5
Yacobi, A.6
Layloff, T.7
Viswanathan, C.T.8
Cook, C.E.9
McDowall, R.D.10
Pittman, K.A.11
Spector, S.12
-
4
-
-
0034469255
-
Bioanalytical method validation: a revisit with a decade of progress
-
Shah VP, Midha KK, Findlay JWA, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A (2000) Bioanalytical method validation: a revisit with a decade of progress. Pharm Res 17: 1155-1551.
-
(2000)
Pharm Res
, vol.17
, pp. 1155-1551
-
-
Shah, V.P.1
Midha, K.K.2
Findlay, J.W.A.3
Hill, H.M.4
Hulse, J.D.5
McGilveray, I.J.6
McKay, G.7
Miller, K.J.8
Patnaik, R.N.9
Powell, M.L.10
Tonelli, A.11
Viswanathan, C.T.12
Yacobi, A.13
-
5
-
-
79951768879
-
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, Vallano PT, Viau A, Zhu Z (2009) The 2nd calibration and validation group workshop on recent issues in good laboratory practice bioanalysis. Bioanalysis 1: 19-30.
-
(2009)
Bioanalysis
, vol.1
, pp. 19-30
-
-
Savoie, N.1
Booth, B.P.2
Bradley, T.3
Garofolo, F.4
Hughes, N.C.5
Hussain, S.6
King, S.P.7
Lindsay, M.8
Lowes, S.9
Ormsby, E.10
Phull, R.11
Rocci, M.L.12
Vallano, P.T.13
Viau, A.14
Zhu, Z.15
-
6
-
-
79951769600
-
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 (2010) White paper on recent issues in regulated bioanalysis from the 3rd calibration and validation group workshop. Bioanalysis 2: 53-68.
-
(2010)
Bioanalysis
, vol.2
, pp. 53-68
-
-
Savoie, N.1
Garofolo, F.2
van Amsterdam, P.3
Booth, B.P.4
Fast, D.M.5
Lindsay, M.6
Lowes, S.7
Masse, R.8
Mawer, L.9
Ormsby, E.10
Phull, R.11
Rocci, M.L.12
Vallano, P.T.13
Yin, X.14
-
7
-
-
33847184252
-
Workshop/conference report-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 (2007) Workshop/conference report-quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J 9: 1962-1973.
-
(2007)
AAPS J
, vol.9
, pp. 1962-1973
-
-
Viswanathan, C.T.1
Bansal, S.2
Booth, B.3
Destefano, A.J.4
Rose, M.J.5
Sailstad, J.6
Shah, V.P.7
Skelly, J.P.8
Swann, P.G.9
Weiner, R.10
-
8
-
-
0036310862
-
Harmonized guidelines for single-laboratory validation of methods of analysis
-
Thompson M, Ellison SLR, Wood R (2002) Harmonized guidelines for single-laboratory validation of methods of analysis. Pure Appl Chem 74: 835-855.
-
(2002)
Pure Appl Chem
, vol.74
, pp. 835-855
-
-
Thompson, M.1
Ellison, S.L.R.2
Wood, R.3
-
9
-
-
0036827348
-
Bioanalytical method validation and its implications for forensic and clinical toxicology-A review
-
Peters FT, Maurer HH (2002) Bioanalytical method validation and its implications for forensic and clinical toxicology-A review. Accred Qual Assur 7: 441-449.
-
(2002)
Accred Qual Assur
, vol.7
, pp. 441-449
-
-
Peters, F.T.1
Maurer, H.H.2
-
11
-
-
79957865569
-
-
International Vocabulary of basic and general terms in Metrology 3Accessed 20 Jan 2011
-
International Vocabulary of basic and general terms in Metrology 3 (2008) Working group 2 of the joint committee for guides in metrology. ISO, Geneva. http://www. bipm. org/vim. Accessed 20 Jan 2011.
-
(2008)
Working group 2 of the joint committee for guides in metrology. ISO, Geneva
-
-
-
12
-
-
79952019611
-
Bioanalytical method validation: notable points in the 2009 draft EMEA guideline and differences with the 2001 FDA guidance
-
Graeme S (2010) Bioanalytical method validation: notable points in the 2009 draft EMEA guideline and differences with the 2001 FDA guidance. Bioanalysis 2: 929-935.
-
(2010)
Bioanalysis
, vol.2
, pp. 929-935
-
-
Graeme, S.1
-
13
-
-
0036100108
-
Validation issues arising from the new FDA guidance for industry on bioanalytical method validation
-
Brodie RR, Hill HM (2002) Validation issues arising from the new FDA guidance for industry on bioanalytical method validation. Chromatographia 52: S91-S94.
-
(2002)
Chromatographia
, vol.52
-
-
Brodie, R.R.1
Hill, H.M.2
-
14
-
-
0029551578
-
Issues in evaluation of bioanalytical method selectivity and drug stability
-
Dadgar D, Burnett PE (1995) Issues in evaluation of bioanalytical method selectivity and drug stability. J Pharm Biomed Anal 14: 23-31.
-
(1995)
J Pharm Biomed Anal
, vol.14
, pp. 23-31
-
-
Dadgar, D.1
Burnett, P.E.2
-
15
-
-
0032986050
-
The effects of sample preparation methods on the variability of the electrospray ionization response for model drug compounds
-
Bonfiglio R, King RC, Olah TV, Merkle K (1999) The effects of sample preparation methods on the variability of the electrospray ionization response for model drug compounds. Rapid Commun Mass Spect 13: 1175-1185.
-
(1999)
Rapid Commun Mass Spect
, vol.13
, pp. 1175-1185
-
-
Bonfiglio, R.1
King, R.C.2
Olah, T.V.3
Merkle, K.4
-
16
-
-
0037663202
-
Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS
-
Matuszewski BK, Constanzer ML, Chavez-Eng CM (2003) Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS. Anal Chem 75: 3019-3030.
-
(2003)
Anal Chem
, vol.75
, pp. 3019-3030
-
-
Matuszewski, B.K.1
Constanzer, M.L.2
Chavez-Eng, C.M.3
-
17
-
-
67650133971
-
Validation of bioanalytical LC-MS/MS assays: evaluation of matrix effects
-
van Eeckhaut A, Lanckmans K, Sarre S, Smolders I, Michotte Y (2009) Validation of bioanalytical LC-MS/MS assays: evaluation of matrix effects. J Chromatogr B 877: 2198-2207.
-
(2009)
J Chromatogr B
, vol.877
, pp. 2198-2207
-
-
van Eeckhaut, A.1
Lanckmans, K.2
Sarre, S.3
Smolders, I.4
Michotte, Y.5
-
18
-
-
30444448196
-
Standard line slopes as a measure of a relative matrix effect in quantitative HPLC-MS bioanalysis
-
Matuszewski BK (2006) Standard line slopes as a measure of a relative matrix effect in quantitative HPLC-MS bioanalysis. J Chromatogr B 830: 293-300.
-
(2006)
J Chromatogr B
, vol.830
, pp. 293-300
-
-
Matuszewski, B.K.1
-
19
-
-
67650106959
-
Method validation across the disciplines-critical investigation of major validation criteria and associated experimental protocols
-
Stöckl D, D'Hondt H, Thienpont LM (2009) Method validation across the disciplines-critical investigation of major validation criteria and associated experimental protocols. J Chromatogr B 877: 2180-2190.
-
(2009)
J Chromatogr B
, vol.877
, pp. 2180-2190
-
-
Stöckl, D.1
D'Hondt, H.2
Thienpont, L.M.3
-
20
-
-
42149112412
-
The limit of detection is not the analyte level for deciding betweendetected and not detected
-
Faber NKM (2008) The limit of detection is not the analyte level for deciding betweendetected and not detected. Accred Qual Assur 13: 277-278.
-
(2008)
Accred Qual Assur
, vol.13
, pp. 277-278
-
-
Faber, N.K.M.1
-
21
-
-
79957825905
-
-
Gas Chromatography/Mass Spectrometry (GC-MS) confirmation of drugs; Approved Guideline
-
Gas Chromatography/Mass Spectrometry (GC-MS) confirmation of drugs; Approved Guideline (2001) NCCLS, Pennsylvania, NCCLS document C43-A.
-
(2001)
NCCLS, Pennsylvania, NCCLS document C43-A
-
-
-
22
-
-
33846924150
-
-
Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results Off J Eu Commun 2002/657/EC
-
Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (2002) European commission. Off J Eu Commun 2002/657/EC.
-
(2002)
European commission
-
-
-
23
-
-
49849094504
-
Weighted least squares in calibration: the problem with using quality coefficients to select weighting formulas
-
Tellinghuisen J (2008) Weighted least squares in calibration: the problem with using quality coefficients to select weighting formulas. J Chromatogr B 872: 162-166.
-
(2008)
J Chromatogr B
, vol.872
, pp. 162-166
-
-
Tellinghuisen, J.1
-
24
-
-
0037099575
-
Linear regression for calibration lines revisited: weighting schemes for bioanalytical methods
-
Almeida AM, Castel-Branco MM, Falcão AC (2002) Linear regression for calibration lines revisited: weighting schemes for bioanalytical methods. J Chromatogr B 774: 215-222.
-
(2002)
J Chromatogr B
, vol.774
, pp. 215-222
-
-
Almeida, A.M.1
Castel-Branco, M.M.2
Falcão, A.C.3
-
25
-
-
67650376579
-
Key aspects of analytical method validation and linearity evaluation
-
Araujo P (2009) Key aspects of analytical method validation and linearity evaluation. J Chromatogr B 877: 2224-2234.
-
(2009)
J Chromatogr B
, vol.877
, pp. 2224-2234
-
-
Araujo, P.1
-
27
-
-
84860515925
-
-
Statistical Quality Control for Quantitative Measurement Procedures: principles and definitions; approved guideline C24-A3-3rd Edition
-
Statistical Quality Control for Quantitative Measurement Procedures: principles and definitions; approved guideline C24-A3-3rd Edition (2006) Clinical and laboratory standards institute, vol 26, no 25, pp 1-31.
-
(2006)
Clinical and laboratory standards institute
, vol.26
, Issue.25
, pp. 1-31
-
-
-
28
-
-
0242721662
-
Internal quality control: planning and implementation strategies
-
Westgard JO (2003) Internal quality control: planning and implementation strategies. Ann Clin Biochem 40: 593-611.
-
(2003)
Ann Clin Biochem
, vol.40
, pp. 593-611
-
-
Westgard, J.O.1
-
29
-
-
0019796502
-
A multi-rule shewhart chart for quality control in clinical chemistry
-
Westgard JO, Barry PL, Hunt MR (1981) A multi-rule shewhart chart for quality control in clinical chemistry. Clin Chem 27: 493-501.
-
(1981)
Clin Chem
, vol.27
, pp. 493-501
-
-
Westgard, J.O.1
Barry, P.L.2
Hunt, M.R.3
-
30
-
-
79957826414
-
-
In: Hovind H, Magnusson B, Krysell M, Lund U, Mäkinen I (eds), Accessed 25 Jan 2011 Nordtest 1
-
Nordtest (2007) Technical Report Internal Quality control(l). In: Hovind H, Magnusson B, Krysell M, Lund U, Mäkinen I (eds). www. nordicinnovation. net. Accessed 25 Jan 2011.
-
(2007)
Technical Report Internal Quality control
-
-
-
32
-
-
78650805924
-
L'incertitude de mesure: une notion à definer en toxicology medico-légale (Measurement uncertainty: to be defined in forensic toxicology)
-
Widmer-Girod C, Staub C (2004) L'incertitude de mesure: une notion à definer en toxicology medico-légale (Measurement uncertainty: to be defined in forensic toxicology). Ann Toxicol Anal 16: 215-219.
-
(2004)
Ann Toxicol Anal
, vol.16
, pp. 215-219
-
-
Widmer-Girod, C.1
Staub, C.2
-
33
-
-
0004217479
-
-
Guide to the Expression of Uncertainty in MeasurementAccessed 10 Sept 2010
-
Guide to the Expression of Uncertainty in Measurement (1993) International organization for Standardization, Geneva. http://www. bipm. org. Accessed 10 Sept 2010.
-
(1993)
International organization for Standardization, Geneva
-
-
-
35
-
-
0034131578
-
The evaluation of measurement uncertainty from method validation studies. Part I: description of a laboratory protocol
-
Barwick VJ, Ellison SLR (2000) The evaluation of measurement uncertainty from method validation studies. Part I: description of a laboratory protocol. Accred Qual Assur 5: 47-53.
-
(2000)
Accred Qual Assur
, vol.5
, pp. 47-53
-
-
Barwick, V.J.1
Ellison, S.L.R.2
-
36
-
-
0034147318
-
The evaluation of measurement uncertainty from method validation studies. Part 2: the practical application of a laboratory protocol
-
Barwick VJ, Ellison SLR, Rafferty MJQ, Gill RS (2000) The evaluation of measurement uncertainty from method validation studies. Part 2: the practical application of a laboratory protocol. Accred Qual Assur 5: 104-113.
-
(2000)
Accred Qual Assur
, vol.5
, pp. 104-113
-
-
Barwick, V.J.1
Ellison, S.L.R.2
Rafferty, M.J.Q.3
Gill, R.S.4
-
37
-
-
4143073185
-
-
In: Magnusson B, Näykki T, Hovind H, Krysell M (eds) Accessed 20 Jan 2011 Nordtest
-
Nordtest (2003) Handbook for calculation of measurement uncertainty in environmental laboratories. In: Magnusson B, Näykki T, Hovind H, Krysell M (eds). http://www. nordtest. org/register/techn/tlibrary/tec537. pdf. Accessed 20 Jan 2011.
-
(2003)
Handbook for calculation of measurement uncertainty in environmental laboratories
-
-
-
39
-
-
0013379958
-
-
Accessed 16 March 2011NIST/SEMATECH
-
NIST/SEMATECH (2010) E-handbook of statistical methods. http://www. itl. nist. gov/div898/handbook/eda/section3/eda354. htm. Accessed 16 March 2011.
-
(2010)
E-handbook of statistical methods
-
-
|