-
2
-
-
17744402127
-
-
Minois-Offroy F., Appriou Y., Brousset V., Chapuzet E., de Fontenay G., Dewé W., Dumas E., Ellie C., Galiay M., Lefebvre N., Mottu P., Quint M.P., and Schoeffter F. STP Pharma Pratiques 12 (2002) 337
-
(2002)
STP Pharma Pratiques
, vol.12
, pp. 337
-
-
Minois-Offroy, F.1
Appriou, Y.2
Brousset, V.3
Chapuzet, E.4
de Fontenay, G.5
Dewé, W.6
Dumas, E.7
Ellie, C.8
Galiay, M.9
Lefebvre, N.10
Mottu, P.11
Quint, M.P.12
Schoeffter, F.13
-
5
-
-
0034100649
-
-
Pisarik L., Blais P.Y., Carraud P., Douere F., Froissant A., Koeberle-Ramond S., Laugel V., Muffat F., and Proteau-Chabrat V. STP Pharma Pratiques 10 (2000) 61
-
(2000)
STP Pharma Pratiques
, vol.10
, pp. 61
-
-
Pisarik, L.1
Blais, P.Y.2
Carraud, P.3
Douere, F.4
Froissant, A.5
Koeberle-Ramond, S.6
Laugel, V.7
Muffat, F.8
Proteau-Chabrat, V.9
-
8
-
-
33847246985
-
-
Dewé W., Govaerts B., Boulanger B., Rozet E., Chiap P., and Hubert Ph. Chemometr. Intell. Lab. Syst. 85 (2007) 262
-
(2007)
Chemometr. Intell. Lab. Syst.
, vol.85
, pp. 262
-
-
Dewé, W.1
Govaerts, B.2
Boulanger, B.3
Rozet, E.4
Chiap, P.5
Hubert, Ph.6
-
9
-
-
67650139991
-
-
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005.
-
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005.
-
-
-
-
10
-
-
67650189862
-
-
Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
-
Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
-
-
-
-
11
-
-
67650107906
-
-
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q9: Quality Risk Management, Geneva, 2005.
-
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q9: Quality Risk Management, Geneva, 2005.
-
-
-
-
12
-
-
67650111135
-
An FDA Perspective on Method Transfer of Chromatographic Analytical Methods in the Pharmaceutical Industry
-
Johnson Y. An FDA Perspective on Method Transfer of Chromatographic Analytical Methods in the Pharmaceutical Industry. The Chromatography Forum of Delaware Valley, October meeting (2004)
-
(2004)
The Chromatography Forum of Delaware Valley, October meeting
-
-
Johnson, Y.1
-
15
-
-
67650126254
-
-
FDA, Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods, U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), April 2007.
-
FDA, Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods, U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), April 2007.
-
-
-
-
16
-
-
34250692034
-
-
Ramond B., Gaillandre A., Gibelin N., Michalski C., Nabet P., Niewiaski C., Poirault D., and Rigal H. STP Pharma Pratiques 17 (2007) 67
-
(2007)
STP Pharma Pratiques
, vol.17
, pp. 67
-
-
Ramond, B.1
Gaillandre, A.2
Gibelin, N.3
Michalski, C.4
Nabet, P.5
Niewiaski, C.6
Poirault, D.7
Rigal, H.8
-
18
-
-
33747775130
-
-
Rozet E., Mertens B., Dewe W., Ceccato A., Govaerts B., Boulanger B., Chiap P., Streel B., Crommen J., and Hubert Ph. J. Pharm. Biomed. Anal. 42 (2006) 64
-
(2006)
J. Pharm. Biomed. Anal.
, vol.42
, pp. 64
-
-
Rozet, E.1
Mertens, B.2
Dewe, W.3
Ceccato, A.4
Govaerts, B.5
Boulanger, B.6
Chiap, P.7
Streel, B.8
Crommen, J.9
Hubert, Ph.10
-
19
-
-
41949089218
-
-
Rozet E., Dewé W., Morello R., Chiap P., Lecomte F., Ziemons E., Boos K.S., Boulanger B., Crommen J., and Hubert Ph. J. Chromatogr. A 1189 (2008) 32
-
(2008)
J. Chromatogr. A
, vol.1189
, pp. 32
-
-
Rozet, E.1
Dewé, W.2
Morello, R.3
Chiap, P.4
Lecomte, F.5
Ziemons, E.6
Boos, K.S.7
Boulanger, B.8
Crommen, J.9
Hubert, Ph.10
-
20
-
-
0035739475
-
-
Kringle R., Khan-Malek R., Snikeris F., Munden P., Agut C., and Bauer M. Drug Inf. J. 35 (2001) 1271
-
(2001)
Drug Inf. J.
, vol.35
, pp. 1271
-
-
Kringle, R.1
Khan-Malek, R.2
Snikeris, F.3
Munden, P.4
Agut, C.5
Bauer, M.6
-
21
-
-
30644476345
-
Application of the statistics-Accuracy (trueness and precision) of the results and methods of measurement. Part 1. General principles and definitions
-
ISO 5725-1, International Organization for Standardization ISO, Geneva
-
ISO 5725-1, Application of the statistics-Accuracy (trueness and precision) of the results and methods of measurement. Part 1. General principles and definitions. International Organization for Standardization (ISO), Geneva, 1994.
-
(1994)
-
-
-
22
-
-
7444240202
-
-
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. J. Pharm. Biomed. Anal. 36 (2004) 579
-
(2004)
J. Pharm. Biomed. Anal.
, vol.36
, pp. 579
-
-
Hubert, Ph.1
Nguyen-Huu, J.-J.2
Boulanger, B.3
Chapuzet, E.4
Chiap, P.5
Cohen, N.6
Compagnon, P.-A.7
Dewé, W.8
Feinberg, M.9
Lallier, M.10
Laurentie, M.11
Mercier, N.12
Muzard, G.13
Nivet, C.14
Valat, L.15
-
23
-
-
67650176075
-
-
International Vocabulary of Basic and General Terms in Metrology, ISO, Geneva
-
International Vocabulary of Basic and General Terms in Metrology, ISO, Geneva, 1993.
-
(1993)
-
-
-
24
-
-
34447103711
-
-
Rozet E., Ceccato A., Hubert C., Ziemons E., Oprean R., Rudaz S., Boulanger B., and Hubert P. J. Chromatogr. A 1158 (2007) 111
-
(2007)
J. Chromatogr. A
, vol.1158
, pp. 111
-
-
Rozet, E.1
Ceccato, A.2
Hubert, C.3
Ziemons, E.4
Oprean, R.5
Rudaz, S.6
Boulanger, B.7
Hubert, P.8
-
30
-
-
33744830863
-
-
Rodriguez S.A., Kubiak R., Mulcey M., Tamblyn T., and Tougas T. Am. Lab. 37 (2005) 9
-
(2005)
Am. Lab.
, vol.37
, pp. 9
-
-
Rodriguez, S.A.1
Kubiak, R.2
Mulcey, M.3
Tamblyn, T.4
Tougas, T.5
-
31
-
-
24644455881
-
-
Chambers D., Kelly G., Limentani G., Lister A., Lung R., and Warner E. Pharm. Technol. September (2005) 64
-
(2005)
Pharm. Technol.
, Issue.September
, pp. 64
-
-
Chambers, D.1
Kelly, G.2
Limentani, G.3
Lister, A.4
Lung, R.5
Warner, E.6
-
32
-
-
36348955648
-
-
Feng S., Liang Q., Kinser R.D., Newland K., and Guilbaud R. Anal. Bioanal. Chem. 385 (2006) 975
-
(2006)
Anal. Bioanal. Chem.
, vol.385
, pp. 975
-
-
Feng, S.1
Liang, Q.2
Kinser, R.D.3
Newland, K.4
Guilbaud, R.5
-
33
-
-
0031859074
-
-
Vial J., Jardy A., Anger P., Brun A., and Menet J.M. J. Chromatogr. A 815 (1998) 173
-
(1998)
J. Chromatogr. A
, vol.815
, pp. 173
-
-
Vial, J.1
Jardy, A.2
Anger, P.3
Brun, A.4
Menet, J.M.5
-
35
-
-
67650166796
-
-
ISO 5725-2, International Organization for Standardization (ISO), Statistical methods for quality control, accuracy (trueness and precision) of measurement methods and results. Part 2. Basic method for the determination of repeatability and reproducibility of a standard measurement method, 2, 4th ed., Geneva, ISO, 1994.
-
ISO 5725-2, International Organization for Standardization (ISO), Statistical methods for quality control, accuracy (trueness and precision) of measurement methods and results. Part 2. Basic method for the determination of repeatability and reproducibility of a standard measurement method, vol. 2, 4th ed., Geneva, ISO, 1994.
-
-
-
-
36
-
-
67650166793
-
Analytical Method Transfer
-
Shanghai, China, June 30-July 2
-
Tsong Y., Zhong J., and Lee K. Analytical Method Transfer. 1st ISBS Symposium. Shanghai, China, June 30-July 2 (2008)
-
(2008)
1st ISBS Symposium
-
-
Tsong, Y.1
Zhong, J.2
Lee, K.3
-
37
-
-
34147101216
-
-
Boulanger B., Dewé W., Gilbert A., Govaerts B., and Maumy-Bertrand M. Chemometr. Intell. Lab. Syst. 86 (2007) 198
-
(2007)
Chemometr. Intell. Lab. Syst.
, vol.86
, pp. 198
-
-
Boulanger, B.1
Dewé, W.2
Gilbert, A.3
Govaerts, B.4
Maumy-Bertrand, M.5
-
39
-
-
34447107152
-
-
Rozet E., Hubert C., Ceccato A., Dewé W., Ziemons E., Moonen F., Michail K., Wintersteiger R., Streel B., Boulanger B., and Hubert Ph. J. Chromatogr. A 1158 (2007) 126
-
(2007)
J. Chromatogr. A
, vol.1158
, pp. 126
-
-
Rozet, E.1
Hubert, C.2
Ceccato, A.3
Dewé, W.4
Ziemons, E.5
Moonen, F.6
Michail, K.7
Wintersteiger, R.8
Streel, B.9
Boulanger, B.10
Hubert, Ph.11
-
42
-
-
0000037284
-
-
Hartmann C., Smeyers-Verbeke J., Penninckx W., Vander Heyden Y., Vankeerberghen P., and Massart D. Anal. Chem. 67 (1995) 4491
-
(1995)
Anal. Chem.
, vol.67
, pp. 4491
-
-
Hartmann, C.1
Smeyers-Verbeke, J.2
Penninckx, W.3
Vander Heyden, Y.4
Vankeerberghen, P.5
Massart, D.6
-
44
-
-
0004057409
-
-
Marcel Dekker, Inc., New York, NY
-
Burdik R., and Graybill F. Confidence Interval on Variance Components (1992), Marcel Dekker, Inc., New York, NY
-
(1992)
Confidence Interval on Variance Components
-
-
Burdik, R.1
Graybill, F.2
-
46
-
-
33847184252
-
-
Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., and Weiner R. AAPS J. 9 (2007) E30. http://www.aapsj.org
-
(2007)
AAPS J.
, vol.9
-
-
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
-
53
-
-
67650130353
-
Fit-for-purpose limits and Tolerance intervals: connecting the assay performance to the clinical trial
-
Leuven, Belgium, September 23-25
-
Jullion A., and Boulanger B. Fit-for-purpose limits and Tolerance intervals: connecting the assay performance to the clinical trial. Non Clinical Statistics Conference. Leuven, Belgium, September 23-25 (2008)
-
(2008)
Non Clinical Statistics Conference
-
-
Jullion, A.1
Boulanger, B.2
-
58
-
-
0242412270
-
-
Tsikas D., Schubert B., Gutzki F.M., Sandmann J., and Frölich J.C. J. Chromatogr. B 798 (2003) 87
-
(2003)
J. Chromatogr. B
, vol.798
, pp. 87
-
-
Tsikas, D.1
Schubert, B.2
Gutzki, F.M.3
Sandmann, J.4
Frölich, J.C.5
-
59
-
-
33751206818
-
-
Rozet E., Morello R., Lecomte F., Martin G.B., Chiap P., Crommen J., Boos K.S., and Hubert Ph. J. Chromatogr. B 844 (2006) 251
-
(2006)
J. Chromatogr. B
, vol.844
, pp. 251
-
-
Rozet, E.1
Morello, R.2
Lecomte, F.3
Martin, G.B.4
Chiap, P.5
Crommen, J.6
Boos, K.S.7
Hubert, Ph.8
-
60
-
-
0033989957
-
-
Findlay J.W.A., Smith W.C., Lee J.W., Nordblom G.D., Das I., DeSilva B.S., Khan M.N., and Bowsher R.R. J. Pharm. Biomed. Anal. 21 (2000) 1249
-
(2000)
J. Pharm. Biomed. Anal.
, vol.21
, pp. 1249
-
-
Findlay, J.W.A.1
Smith, W.C.2
Lee, J.W.3
Nordblom, G.D.4
Das, I.5
DeSilva, B.S.6
Khan, M.N.7
Bowsher, R.R.8
-
61
-
-
20944433395
-
-
Lee J.W., Weiner R.S., Sailstad J.M., Bowsher R.R., Knuth D.W., O'Brien P.J., Foucroy J.L., Dixit R., Pandite L., Pietrusko R.G., Soares H.D., Quarmby V., Vesterqvist O.L., Potter D.M., Witliff J.L., Fritche H.A., O'Learly T., Perlee L., Kadam S., and Wagner J.A. Pharm. Res. 22 (2005) 499
-
(2005)
Pharm. Res.
, vol.22
, pp. 499
-
-
Lee, J.W.1
Weiner, R.S.2
Sailstad, J.M.3
Bowsher, R.R.4
Knuth, D.W.5
O'Brien, P.J.6
Foucroy, J.L.7
Dixit, R.8
Pandite, L.9
Pietrusko, R.G.10
Soares, H.D.11
Quarmby, V.12
Vesterqvist, O.L.13
Potter, D.M.14
Witliff, J.L.15
Fritche, H.A.16
O'Learly, T.17
Perlee, L.18
Kadam, S.19
Wagner, J.A.20
more..
|