-
1
-
-
34247469091
-
-
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.
-
-
-
-
2
-
-
34247484629
-
-
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.
-
-
-
-
3
-
-
34247495314
-
-
Commission Decision 2002/657/EC, Off. J. Eur. Commun., L 221 (2002) 8.
-
-
-
-
4
-
-
34247473184
-
-
Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
-
-
-
-
5
-
-
0033030353
-
-
Hubert Ph., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce Ph., Laparra M.C., Laurentie M., and Nivet J.C. Anal. Chim. Acta 391 (1999) 135-148
-
(1999)
Anal. Chim. Acta
, vol.391
, pp. 135-148
-
-
Hubert, Ph.1
Chiap, P.2
Crommen, J.3
Boulanger, B.4
Chapuzet, E.5
Mercier, N.6
Bervoas-Martin, S.7
Chevalier, P.8
Grandjean, D.9
Lagorce, Ph.10
Laparra, M.C.11
Laurentie, M.12
Nivet, J.C.13
-
8
-
-
0034469255
-
-
Shah V.P., Midha K.K., Findlay J.W.A., Hill H.M., Hulse J.D., McGilveray I.J., McLay G., Miller K.J., Patnaik R.N., Powell M.L., Tonelli A., Viswanathan C.T., and Yacobi A. Pharm. Res. 17 (2000) 1551-1557
-
(2000)
Pharm. Res.
, vol.17
, pp. 1551-1557
-
-
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
McLay, G.7
Miller, K.J.8
Patnaik, R.N.9
Powell, M.L.10
Tonelli, A.11
Viswanathan, C.T.12
Yacobi, A.13
-
9
-
-
0042625050
-
-
Boulanger B., Dewe W., Chiap P., Crommen J., and Hubert Ph. J. Pharm. Biomed. Anal. 32 (2003) 753-765
-
(2003)
J. Pharm. Biomed. Anal.
, vol.32
, pp. 753-765
-
-
Boulanger, B.1
Dewe, W.2
Chiap, P.3
Crommen, J.4
Hubert, Ph.5
-
11
-
-
9644289368
-
-
Boudreau S.P., McElvain J.S., Martin L.D., Dowling T., and Fields S.M. Pharm. Technol. (2004) 54-66
-
(2004)
Pharm. Technol.
, pp. 54-66
-
-
Boudreau, S.P.1
McElvain, J.S.2
Martin, L.D.3
Dowling, T.4
Fields, S.M.5
-
12
-
-
32544451155
-
-
Lee J.W., Devanarayan V., Barrett Y.C., Weiner R., Allinson J., Fountain S., Keller S., Weinryb I., Green M., Duan L., Rogers J.A., Millham R., O'Brien P.J., Sailstad J., Khan M., Ray C., and Wagner J.A. Pharm. Res. 23 (2006) 312-328
-
(2006)
Pharm. Res.
, vol.23
, pp. 312-328
-
-
Lee, J.W.1
Devanarayan, V.2
Barrett, Y.C.3
Weiner, R.4
Allinson, J.5
Fountain, S.6
Keller, S.7
Weinryb, I.8
Green, M.9
Duan, L.10
Rogers, J.A.11
Millham, R.12
O'Brien, P.J.13
Sailstad, J.14
Khan, M.15
Ray, C.16
Wagner, J.A.17
-
13
-
-
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) 579-586
-
(2004)
J. Pharm. Biomed. Anal.
, vol.36
, pp. 579-586
-
-
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
-
14
-
-
34247545224
-
-
Process Analytical Technology (PAT) Initiative, US Food and Drug Administration, Rockville, MD, 2004; http://www.fda.gov/cder/OPS/PAT.htm.
-
-
-
-
15
-
-
34247495758
-
-
Food and Drug Administration, International Conference on Harmonization (ICH): Quality Risk Management (Q9), Fed. Regist., vol. 71 (2006) 32105-32106.
-
-
-
-
16
-
-
34247544523
-
-
The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics, Eurachem, Teddington, 1998.
-
-
-
-
21
-
-
34247469541
-
-
P. Dagnelie, Théorie et méthodes statistiques vol. 1 et 2, Les presses agronomiques de Gembloux, Gembloux, 1994.
-
-
-
-
27
-
-
0034352086
-
-
Tierney M.J., Tamada J.A., Potts R.O., Eastman R.C., Pitzer K., Ackerman N.R., and Fermi S.J. Ann. Med. 32 (2000) 632-641
-
(2000)
Ann. Med.
, vol.32
, pp. 632-641
-
-
Tierney, M.J.1
Tamada, J.A.2
Potts, R.O.3
Eastman, R.C.4
Pitzer, K.5
Ackerman, N.R.6
Fermi, S.J.7
-
28
-
-
0037332157
-
-
Farkas A., Vamos R., Bajor T., Mullner N., Lazar A., and Hraba A. Exp. Eye Res. 76 (2003) 183-192
-
(2003)
Exp. Eye Res.
, vol.76
, pp. 183-192
-
-
Farkas, A.1
Vamos, R.2
Bajor, T.3
Mullner, N.4
Lazar, A.5
Hraba, A.6
-
30
-
-
84988175795
-
-
Shah V.P., Midha K.K., Dighe S., McGilveray I.J., Skelly J.P., Yacobi A., Layloff T., Viswanathan C.T., Cook C.E., McDowall R.D., Pittman K.A., and Spector S. J. Pharm. Sci. 81 (1992) 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
-
31
-
-
0033030353
-
-
Hubert Ph., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce P., Lallier M., Laparra M.C., Laurentie M., and Nivet J.C. Anal. Chim. Acta 391 (1999) 135
-
(1999)
Anal. Chim. Acta
, vol.391
, pp. 135
-
-
Hubert, Ph.1
Chiap, P.2
Crommen, J.3
Boulanger, B.4
Chapuzet, E.5
Mercier, N.6
Bervoas-Martin, S.7
Chevalier, P.8
Grandjean, D.9
Lagorce, P.10
Lallier, M.11
Laparra, M.C.12
Laurentie, M.13
Nivet, J.C.14
|