-
3
-
-
40149111537
-
The application of quality by design to analytical methods
-
Borman, P.; Nethercote, P.; Chatfield, M.; Thompson, D.; Truman K. The Application of Quality by Design to Analytical Methods. Pharm. Tech. 2007,31(12) 142-152.
-
(2007)
Pharm. Tech.
, vol.31
, Issue.12
, pp. 142-152
-
-
Borman, P.1
Nethercote, P.2
Chatfield, M.3
Thompson, D.4
Truman, K.5
-
4
-
-
77950677448
-
Implications and opportunities of applying QbD principles to analytical measurements
-
Schweitzer, M.; Pohl, M.; Hanna-Brown, M.; Nethercote, P.; Borman, P.; Hansen, G.; Smith, K.; Larew J. Implications and Opportunities of Applying QbD Principles to Analytical Measurements. Pharm. Tech. 2010,34 (2) 52-59.
-
(2010)
Pharm. Tech.
, vol.34
, Issue.2
, pp. 52-59
-
-
Schweitzer, M.1
Pohl, M.2
Hanna-Brown, M.3
Nethercote, P.4
Borman, P.5
Hansen, G.6
Smith, K.7
Larew, J.8
-
5
-
-
79251534699
-
Development of quality-by-design analytical methods
-
Vogt, F.G.; Kord AS. Development of Quality-By-Design Analytical Methods. J. Pharm. Sci. 2011,100(3), 797-812.
-
(2011)
J. Pharm. Sci.
, vol.100
, Issue.3
, pp. 797-812
-
-
Vogt, F.G.1
Kord, A.S.2
-
6
-
-
79251574952
-
QbD approach to analytical RP-HPLC method development and its validation
-
Bhatt, D.A; Rane, S.I. QbD Approach to Analytical RP-HPLC Method Development and its Validation. Int. J. Pharm. and Pharm. Sci. 2011,3(1) 179-187.
-
(2011)
Int. J. Pharm. and Pharm. Sci.
, vol.3
, Issue.1
, pp. 179-187
-
-
Bhatt, D.A.1
Rane, S.I.2
-
7
-
-
59449090381
-
A quality-by-design methodology for rapid LC method development, Part i
-
Krull, I.; Swartz, M.; Turpin, J.; Lukulay, P.H.; Verseput, R. AQuality-by-Design Methodology for Rapid LC Method Development, Part I. LCGC N. Am. 2008,26,1190-1197.
-
(2008)
LCGC N. Am.
, vol.26
, pp. 1190-1197
-
-
Krull, I.1
Swartz, M.2
Turpin, J.3
Lukulay, P.H.4
Verseput, R.5
-
8
-
-
77951834525
-
A quality-by-design methodology for rapid LC method development, Part II
-
Krull, I.; Swartz, M.; Turpin, J.; Lukulay, P.H.; Verseput, R. AQuality-by-Design Methodology for Rapid LC Method Development, Part II. LCGC N. Am. 2009,27,48-61.
-
(2009)
LCGC N. Am.
, vol.27
, pp. 48-61
-
-
Krull, I.1
Swartz, M.2
Turpin, J.3
Lukulay, P.H.4
Verseput, R.5
-
9
-
-
78650941142
-
Highlights of analytical chemistryin Switzerland
-
Meyer, C; Soldo, T.; Kettenring, U. Highlights of Analytical Chemistryin Switzerland. Chimia 2010,64(11), 825.
-
(2010)
Chimia
, vol.64
, Issue.11
, pp. 825
-
-
Meyer, C.1
Soldo, T.2
Kettenring, U.3
-
10
-
-
84864127178
-
-
am Ende D.J. Ed.; John Wiley & Sons: New York
-
Graul, T.W.; Barnett, K.L.; Bale, S.J.; Gill, I; Hanna-Brown M. in Chemical Engineers in the Pharmaceutical Industry: R&D to Manufacturing; am Ende, D.J. Ed.; John Wiley & Sons: New York, 2011, pp 545-562.
-
(2011)
Chemical Engineers in the Pharmaceutical Industry: R&D to Manufacturing
, pp. 545-562
-
-
Graul, T.W.1
Barnett, K.L.2
Bale, S.J.3
Gill, I.4
Hanna-Brown, M.5
-
11
-
-
84882324113
-
A quality by design approach to chromatographic method development
-
Ling S.; McBrien, M. AQuality by Design Approach to Chromatographic Method Development. LCGC: The Column 2011,7(5), 16-20.
-
(2011)
LCGC: The Column
, vol.7
, Issue.5
, pp. 16-20
-
-
Ling, S.1
McBrien, M.2
-
12
-
-
77951977827
-
"Design Space" in high pressure liquid chromatography method development
-
Molnar, I.; Rieger, H.-J.; Monks, K.E. Aspects of the "Design Space" in high pressure liquid chromatography method development. J. Chromatogr. A2010,1217,3193-3200.
-
(2010)
J. Chromatogr
, vol.1217
, pp. 3193-3200
-
-
Molnar, I.1
Rieger, H.-J.2
Monks, K.E.3
-
13
-
-
79959445884
-
Quality by design (QbD) based development of a stability indicating HPLC method for drug and impurities
-
Karmarkar, S.; Garber, R.; Genchanok, Y; George, S.; Yang.X; Hammond, R. Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities. J. Chromatogr. Sci. 2011,49,439-446.
-
(2011)
J. Chromatogr. Sci.
, vol.49
, pp. 439-446
-
-
Karmarkar, S.1
Garber, R.2
Genchanok, Y.3
George, S.4
Yang, X.5
Hammond, R.6
-
14
-
-
80052801345
-
"Design Space" in high performance liquid chromatography (I)
-
Monks, K.E.; Rieger, H.-J.; Molnar, I. Expanding the term "Design Space" in high performance liquid chromatography (I). J. Pharm. Biomed. Anal. 2011,56 (5), 874-879.
-
(2011)
J. Pharm. Biomed. Anal.
, vol.56
, Issue.5
, pp. 874-879
-
-
Monks, K.E.1
Rieger, H.-J.2
Molnar, I.3
-
15
-
-
84882395173
-
Reversed- phase liquid chromatographic method development in an analytical quality by design framework
-
DOI:10.1080/10826076.2013.765457
-
Reid, G.L; Cheng, G; Fortin, D.T; Harwood, J.H.; Morgado, J.E.; Wang, J.; Xue, G. Reversed- Phase Liquid Chromatographic Method Development in an Analytical Quality by Design Framework, J. of Liq. Chromatogr. Relat. Tech., 2013, DOI:10.1080/10826076.2013.765457.
-
(2013)
J. of Liq. Chromatogr. Relat. Tech.
-
-
Reid, G.L.1
Cheng, G.2
Fortin, D.T.3
Harwood, J.H.4
Morgado, J.E.5
Wang, J.6
Xue, G.7
-
16
-
-
84858079402
-
Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation
-
Monks, K.; Molnar, I.; Rieger, H.-J.; Bogati, B.; Szabo, E. Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation. J. Chromatogr. A2012,1232,218-230.
-
J. Chromatogr
, vol.1232 A2012
, pp. 218-230
-
-
Monks, K.1
Molnar, I.2
Rieger, H.-J.3
Bogati, B.4
Szabo, E.5
-
17
-
-
84873701785
-
Application of quality by design to the development of analytical separation methods
-
Orlandini, S.; Pinzauti S.; Furlanetto S. Application of quality by design to the development of analytical separation methods, Anal Bioanal Chem. 2013,405,443-450
-
(2013)
Anal Bioanal Chem
, Issue.405
, pp. 443-450
-
-
Orlandini, S.1
Pinzauti, S.2
Furlanetto, S.3
-
18
-
-
84872744434
-
Applying QbD principles to develop a generic UHPLC method which facilitates continual improvement and innovation throughout the product lifecycle for a commercial API
-
Musters, J.; van den Bos, L.; Kellenbach, E. Applying QbD Principles To Develop a Generic UHPLC Method Which Facilitates Continual Improvement and Innovation Throughout the Product Lifecycle for a Commercial API. Org. Process Res. Dev. 2013,17,87-96.
-
(2013)
Org. Process Res. Dev
, vol.17
, pp. 87-96
-
-
Musters, J.1
Van Den Bos, L.2
Kellenbach, E.3
-
19
-
-
84871522634
-
Design spaces for analytical methods
-
Rozet, E.; Lebrun, P.; Debrus, B.; Boulanger, B.; Hubert P. Design Spaces for analytical Methods. Trends in Analytical Chemistry, 2013,42,157-167.
-
(2013)
Trends in Analytical Chemistry
, vol.42
, pp. 157-167
-
-
Rozet, E.1
Lebrun, P.2
Debrus, B.3
Boulanger, B.4
Hubert, P.5
-
21
-
-
84885641306
-
Acceptable analytical method variation - Setting system suitability requirements
-
Cecil, Todd; Acceptable Analytical Method Variation - Setting System Suitability Requirements, Pittcon 2013
-
(2013)
Pittcon
-
-
Cecil, T.1
-
22
-
-
84901870073
-
-
Fanali, S.; Haddad, P.R.; Poole, C.F. Eds; Elsevier
-
Barnett, K.L.; Harrington, B.;. Graul, T.W. in Liquid Chromatography Applications; Fanali, S.; Haddad, P.R.; Poole, C.F. Eds; Elsevier, 2013, pp 57-73.
-
(2013)
Liquid Chromatography Applications
, pp. 57-73
-
-
Barnett, K.L.1
Harrington, B.2
Graul, T.W.3
-
23
-
-
7444240202
-
Harmonization of strategies for the validation of quantitative analytical procedures ASFSTP proposal-part i
-
Huberta, Ph.; Nguyen-Huub, J.-J.; Boulangerc, B.; Chapuzetd, E.; Chiapa, P.; Cohene, N.; Compagnonf, P.-A; Dewéc, W.; Feinbergg, M.; Lallierh, M.; Laurentiei, M.; Mercierd, N.; Muzardj, G.; Nivetk, C; Valatl, L. Harmonization of strategies for the validation of quantitative analytical procedures ASFSTP proposal-part I. J. Pharm. Biomed. Anal. 2004,36,579-586.
-
(2004)
J. Pharm. Biomed. Anal.
, vol.36
, pp. 579-586
-
-
Huberta, Ph.1
Nguyen-Huub, J.-J.2
Boulangerc, B.3
Chapuzetd, E.4
Chiapa, P.5
Cohene, N.6
Compagnonf, P.-A.7
Dewéc, W.8
Feinbergg, M.9
Lallierh, M.10
Laurentiei, M.11
Mercierd, N.12
Muzardj, G.13
Nivetk, C.14
Valatl, L.15
-
25
-
-
84885649426
-
Principles of instrumental analysis
-
Skoog, DA, Holler, F.J, Crouch, S.R. Principles of Instrumental Analysis, Thomson Learning, 2006.
-
(2006)
Thomson Learning
-
-
Skoog, D.A.1
Holler, F.J.2
Crouch, S.R.3
-
32
-
-
84864137320
-
Process analytical technology (PAT) in pharmaceutical development
-
Reid, G.L., Ward, H., Palm AS., Muteki, K. Process Analytical Technology (PAT) in Pharmaceutical Development, Amer. Pharm. Rev. 2012,15(4), 49-55.
-
(2012)
Amer. Pharm. Rev
, vol.15
, Issue.4
, pp. 49-55
-
-
Reid, G.L.1
Ward, H.2
Palm, A.S.3
Muteki, K.4
-
35
-
-
84885638270
-
QbD considerations for analytical methods - FDA perspective
-
Baltimore, January25, Sharmista Chatterjee, Ph.D., CMC Lead for QbD ONDQA/CDER/FDA
-
QbD Considerations for Analytical Methods - FDA Perspective, presented atthe IFPAC Annual Meeting, Baltimore, January25,2013, Sharmista Chatterjee, Ph.D., CMC Lead for QbD ONDQA/CDER/FDA.
-
(2013)
IFPAC Annual Meeting
-
-
|