-
1
-
-
4344586777
-
-
ICH Geneva, Switzerland, Feb. 5
-
International Conference on Harmonization, Q3B: Impurities in New Drug Products (ICH Geneva, Switzerland, Feb. 5, 2003).
-
(2003)
Impurities in New Drug Products
-
-
-
2
-
-
0033752226
-
Establishing scientifically justified acceptance criteria for cleaning validation of APIs
-
D.A. LeBlanc, "Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of APIs" Pharm. Technol. 24 (10), 160-168 (2000).
-
(2000)
Pharm. Technol.
, vol.24
, Issue.10
, pp. 160-168
-
-
Leblanc, D.A.1
-
3
-
-
7844220598
-
Establishing scientifically justified acceptance criteria for cleaning validation of finished drug products
-
D.A. LeBlanc, "Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of Finished Drug Products," Pharm. Technol. 22 (10), 136-148 (1998).
-
(1998)
Pharm. Technol.
, vol.22
, Issue.10
, pp. 136-148
-
-
Leblanc, D.A.1
-
4
-
-
0030063429
-
Application of total organic carbon analysis to cleaning validation
-
K.M. Jenkins et al., "Application of Total Organic Carbon Analysis to Cleaning Validation," PDA J. Pharm. Sci. Technol. 50 (1), 6-15 (1996).
-
(1996)
PDA J. Pharm. Sci. Technol.
, vol.50
, Issue.1
, pp. 6-15
-
-
Jenkins, K.M.1
-
5
-
-
0006442222
-
Points to consider for cleaning validation - Technical report No. 29
-
"Points to Consider for Cleaning Validation-Technical Report No. 29," PDA J. Pharm. Sci. Technol. 52 (6), 1-23 (1998).
-
(1998)
PDA J. Pharm. Sci. Technol.
, vol.52
, Issue.6
, pp. 1-23
-
-
-
6
-
-
14644422155
-
A validated HPLC method for determining residues of a dual active ingredient anti-malarial drug on manufacturing equipment surfaces
-
M.B. Boca, Z. Apostolides, and E. Pretorius, "A Validated HPLC Method for Determining Residues of a Dual Active Ingredient Anti-Malarial Drug on Manufacturing Equipment Surfaces," J. Pharm. Biomed. Anal. 37 (3), 461-468 (2005).
-
(2005)
J. Pharm. Biomed. Anal.
, vol.37
, Issue.3
, pp. 461-468
-
-
Boca, M.B.1
Apostolides, Z.2
Pretorius, E.3
-
7
-
-
0037026372
-
Development and validation of an LC assay for sumatriptan succinate residues on surfaces in the manufacture of pharmaceuticals
-
M.J. Nozal et al., "Development and Validation of an LC Assay for Sumatriptan Succinate Residues on Surfaces in the Manufacture of Pharmaceuticals," J. Pharm. Biomed. Anal. 30 (2), 285-291 (2002).
-
(2002)
J. Pharm. Biomed. Anal.
, vol.30
, Issue.2
, pp. 285-291
-
-
Nozal, M.J.1
-
8
-
-
0034664090
-
Development and validation of an HPLC assay for fentanyl, alfentanil, and sufentanil in Swab samples
-
J. Lambropoulos, G.A. Spanos, and N.V. Lazaridis, "Development and Validation of an HPLC Assay for Fentanyl, Alfentanil, and Sufentanil in Swab Samples," J. Pharm. Biomed. Anal. 23 (2-3), 421-428 (2000).
-
(2000)
J. Pharm. Biomed. Anal.
, vol.23
, Issue.2-3
, pp. 421-428
-
-
Lambropoulos, J.1
Spanos, G.A.2
Lazaridis, N.V.3
-
9
-
-
0033120887
-
Cleaning level acceptance criteria and a high pressure liquid chromatography procedure for the assay of meclizine hydrochloride residue in Swabs collected from pharmaceutical manufacturing equipment surfaces
-
T. Mirza et. al., "Cleaning Level Acceptance Criteria and a High Pressure Liquid Chromatography Procedure for the Assay of Meclizine Hydrochloride Residue in Swabs Collected from Pharmaceutical Manufacturing Equipment Surfaces," J. Pharm. Biomed Anal. 19 (5), 747-756 (1999).
-
(1999)
J. Pharm. Biomed Anal.
, vol.19
, Issue.5
, pp. 747-756
-
-
Mirza, T.1
-
10
-
-
0032006070
-
Capillary gas chromatographic assay of residual methenamine hippurate in equipment cleaning validation swabs
-
T. Mirza et al., "Capillary Gas Chromatographic Assay of Residual Methenamine Hippurate in Equipment Cleaning Validation Swabs," J. Pharm. Biomed. Anal. 16 (6), 939-950 (1998).
-
(1998)
J. Pharm. Biomed. Anal.
, vol.16
, Issue.6
, pp. 939-950
-
-
Mirza, T.1
-
11
-
-
0033981685
-
Cleaning validation procedure eased by using overpressured layer chromatography
-
Z. Katona et al., "Cleaning Validation Procedure Eased by Using Overpressured Layer Chromatography," J. Pharm. Biomed. Anal. 22 (2), 349-353 (2000).
-
(2000)
J. Pharm. Biomed. Anal.
, vol.22
, Issue.2
, pp. 349-353
-
-
Katona, Z.1
-
12
-
-
0036335120
-
Using ion mobility spectrometry for cleaning verification in pharmaceutical manufacturing
-
R. Debono et al., "Using Ion Mobility Spectrometry for Cleaning Verification in Pharmaceutical Manufacturing." Pharm. Technol. North America 26 (4), 72-78 (2002).
-
(2002)
Pharm. Technol. North America
, vol.26
, Issue.4
, pp. 72-78
-
-
Debono, R.1
-
13
-
-
33646698475
-
Pharmaceutical analysis nearer the sampling point: Use of simple, rapid on-site immunoassays for cleaning validation, health and safety, and environmental release applications
-
F.J. Rowell, Z.F. Miao, and R.N. Neeve, "Pharmaceutical Analysis Nearer the Sampling Point: Use of Simple, Rapid On-Site Immunoassays for Cleaning Validation, Health and Safety, and Environmental Release Applications," J. Pharmacy and Pharmacology 50, 47 (1998).
-
(1998)
J. Pharmacy and Pharmacology
, vol.50
, pp. 47
-
-
Rowell, F.J.1
Miao, Z.F.2
Neeve, R.N.3
-
14
-
-
0035147506
-
Prediction of a new drug's potential to cause idiosyncratic reactions
-
J. Uetrecht, "Prediction of a New Drug's Potential to Cause Idiosyncratic Reactions," Curr. Opin. Drug Discov. Devel. 4 (1), 55-59 (2001).
-
(2001)
Curr. Opin. Drug Discov. Devel.
, vol.4
, Issue.1
, pp. 55-59
-
-
Uetrecht, J.1
-
15
-
-
33646688932
-
-
Morris Plains, NJ
-
Capsugel, (www.xcelodose.com, Morris Plains, NJ), Accessed Jan. 12, 2006.
-
-
-
-
16
-
-
0038748914
-
The impact of atmospheric pressure ionization
-
D. T. Rossi and M. W. Sinz, Eds. Marcel Dekker, New York
-
D.T. Rossi, "The Impact of Atmospheric Pressure Ionization," in Mass Spectrometry in Drug Discovery, D. T. Rossi and M. W. Sinz, Eds. (Marcel Dekker, New York, 2002), pp. 15-24.
-
(2002)
Mass Spectrometry in Drug Discovery
, pp. 15-24
-
-
Rossi, D.T.1
-
17
-
-
0032011562
-
Matrix effect in quantitative LC-MS-MS analyses of biological fluids: A method for determination of finasteride in human plasma at picogram Per milliliter concentrations
-
B.K. Matuszewski, M.L. Constanzer, and C.M. Chavez-Eng, "Matrix Effect in Quantitative LC-MS-MS Analyses of Biological Fluids: A Method for Determination of Finasteride in Human Plasma at Picogram Per Milliliter Concentrations," Anal. Chem. 70 (5), 882-889 (1998).
-
(1998)
Anal. Chem.
, vol.70
, Issue.5
, pp. 882-889
-
-
Matuszewski, B.K.1
Constanzer, M.L.2
Chavez-Eng, C.M.3
-
18
-
-
0034014047
-
Trace level quantitation of Iralukast in human plasma by microbore liquid chromatography-tandem mass spectrometry
-
T.K. Majumdar et al., "Trace Level Quantitation of Iralukast in Human Plasma by Microbore Liquid Chromatography-Tandem Mass Spectrometry," Rapid Commun. Mass Spectrom. 14 (6), 476-481 (2000).
-
(2000)
Rapid Commun. Mass Spectrom.
, vol.14
, Issue.6
, pp. 476-481
-
-
Majumdar, T.K.1
-
19
-
-
0037656361
-
Breaking down barriers: Can LC-MS revolutionize the quantitation of drug product impurities?
-
K.J. Kolodsick, D.T. Rossi, and C.A. Kingsmill, "Breaking Down Barriers: Can LC-MS Revolutionize the Quantitation of Drug Product Impurities?"LCGC North America 21 (5), 468-479 (2003).
-
(2003)
LCGC North America
, vol.21
, Issue.5
, pp. 468-479
-
-
Kolodsick, K.J.1
Rossi, D.T.2
Kingsmill, C.A.3
-
20
-
-
1542791512
-
High performance liquid chromatography with atmospheric pressure ionization tandem mass spectrometry as a tool in quantitative bioanalytical chemistry
-
P. Snyder Ed. ACS Symposium Series #619, Washington DC
-
J.D. Gilbert, T.V. Olah, and D.A. McLoughlin, "High Performance Liquid Chromatography with Atmospheric Pressure Ionization Tandem Mass Spectrometry as a Tool in Quantitative Bioanalytical Chemistry," in Biochemical and Biotechnological Applications of Electrospray Ionization Mass Spectrometry, P. Snyder Ed. (ACS Symposium Series #619, Washington DC, 1996), pp. 330-350.
-
(1996)
Biochemical and Biotechnological Applications of Electrospray Ionization Mass Spectrometry
, pp. 330-350
-
-
Gilbert, J.D.1
Olah, T.V.2
McLoughlin, D.A.3
-
21
-
-
0038574979
-
Ion suppression in mass spec trometry
-
T.M. Annesley, "Ion Suppression in Mass Spec trometry." Clin. Chem. 49 (7), 1041-1044 (2003).
-
(2003)
Clin. Chem.
, vol.49
, Issue.7
, pp. 1041-1044
-
-
Annesley, T.M.1
-
22
-
-
0037246645
-
Internal standard signal suppression by co-eluting analyte in isotope dilution LC-ESI-MS
-
L.E. Sojo, G. Lum, and P. Chee, "Internal Standard Signal Suppression by Co-Eluting Analyte in Isotope Dilution LC-ESI-MS," The Analyst 128 (1), 51-54 (2003).
-
(2003)
The Analyst
, vol.128
, Issue.1
, pp. 51-54
-
-
Sojo, L.E.1
Lum, G.2
Chee, P.3
-
23
-
-
0004053080
-
-
Wiley-Interscience, New York, 2nd ed.
-
L.R. Snyder, J.J. Kirkland, and J.L. Glajch, Practical HPLC Method Development (Wiley-Interscience, New York, 2nd ed., 1997), pp. 692-693.
-
(1997)
Practical HPLC Method Development
, pp. 692-693
-
-
Snyder, L.R.1
Kirkland, J.J.2
Glajch, J.L.3
-
24
-
-
2142710896
-
Selecting the best curve fit
-
M.M. Kiser and J. W. Dolan, "Selecting the Best Curve Fit," LCGC Europe 17 (3), 138-143 (2004).
-
(2004)
LCGC Europe
, vol.17
, Issue.3
, pp. 138-143
-
-
Kiser, M.M.1
Dolan, J.W.2
|