-
1
-
-
0008661875
-
-
U.S. Department of Health and Human Services, Food and Drug Administration, Rockville, MD 20857
-
Analytical Procedures and Methods Validation 2000, U.S. Department of Health and Human Services, Food and Drug Administration, Rockville, MD 20857. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122858.pdf.
-
(2000)
Analytical Procedures and Methods Validation
-
-
-
2
-
-
78649943618
-
-
Federal Register 21 CFR 211A65 (e) and 211A94 (a)(2).
-
Federal Register 21 CFR 211A65 (e) and 211A94 (a)(2).
-
-
-
-
3
-
-
34547803692
-
The role of and the place of method validation in the quality assurance and quality control (QA/QC) system
-
Konieczka P. The role of and the place of method validation in the quality assurance and quality control (QA/QC) system. Crit. Rev. Anal. Chem. 2007, 37:173-190.
-
(2007)
Crit. Rev. Anal. Chem.
, vol.37
, pp. 173-190
-
-
Konieczka, P.1
-
4
-
-
9644308053
-
-
John Wiley & Sons, Inc.
-
Chan Chung Chow, Lee Y.C., Lam H., Zhang XueMing Analytical Method Validation and Instrument Performance Verification 2004, John Wiley & Sons, Inc.
-
(2004)
Analytical Method Validation and Instrument Performance Verification
-
-
Chan, C.C.1
Lee, Y.C.2
Lam, H.3
Zhang, X.4
-
9
-
-
78649952346
-
-
ICH Q2 (R1) International Conference on Harmonisation. Validation of Analytical procedures: Text and Methodology.
-
ICH Q2 (R1) International Conference on Harmonisation. Validation of Analytical procedures: Text and Methodology. http://www.ich.org.
-
-
-
-
10
-
-
0003646348
-
-
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857
-
Reviewers guidance, validation of chromatographic methods 1994, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM134409.pdf.
-
(1994)
Reviewers guidance, validation of chromatographic methods
-
-
-
12
-
-
78649944383
-
-
ICH Q2A International Conference on Harmonisation. Text on Validation of Analytical Procedures.
-
ICH Q2A International Conference on Harmonisation. Text on Validation of Analytical Procedures.
-
-
-
-
13
-
-
78649953097
-
-
ICH Q2B International Conference on Harmonisation. Validation of Analytical Procedures: Methodology.
-
ICH Q2B International Conference on Harmonisation. Validation of Analytical Procedures: Methodology.
-
-
-
-
14
-
-
0035097208
-
Validation in pharmaceutical analysis. Part I: An integrated approach
-
Ermer J. Validation in pharmaceutical analysis. Part I: An integrated approach. J. Pharm. Biomed. Anal. 2001, 24:755-767.
-
(2001)
J. Pharm. Biomed. Anal.
, vol.24
, pp. 755-767
-
-
Ermer, J.1
-
15
-
-
0029878139
-
Chromatographic method validation II. Guidelines for primary validation parameters
-
Jenke D.R. Chromatographic method validation II. Guidelines for primary validation parameters. J. Liq. Chromatogr. Relat. Technol. 1996, 19:737-757.
-
(1996)
J. Liq. Chromatogr. Relat. Technol.
, vol.19
, pp. 737-757
-
-
Jenke, D.R.1
-
16
-
-
0000069766
-
A life cycle approach to validation of analytical methods during pharmaceutical product development I. The initial validation process
-
Hokanson G.C. A life cycle approach to validation of analytical methods during pharmaceutical product development I. The initial validation process. Pharm. Technol. 1994, 18:118-130.
-
(1994)
Pharm. Technol.
, vol.18
, pp. 118-130
-
-
Hokanson, G.C.1
-
17
-
-
78649957459
-
Computer systems validation-Staying current: Introduction
-
PMA Computer Systems Validation Committee
-
Computer systems validation-Staying current: Introduction. Pharm. Technol. 1980, 13:60-65. PMA Computer Systems Validation Committee.
-
(1980)
Pharm. Technol.
, vol.13
, pp. 60-65
-
-
-
18
-
-
78649941142
-
-
ICH Q8(R1) International Conference on Harmonisation, Pharmaceutical Development, .
-
ICH Q8(R1) International Conference on Harmonisation, Pharmaceutical Development, http://www.ich.org.
-
-
-
-
19
-
-
77951287723
-
QbD for analytical methods
-
Krause S. QbD for analytical methods. Biopharm. Int. Feb, 2009.
-
(2009)
Biopharm. Int.
-
-
Krause, S.1
-
21
-
-
67649983045
-
A systematic approach to RP-HPLC method development in a pharmaceutical QbD environment
-
Li Y., Terfloth G.J., Kord A.S. A systematic approach to RP-HPLC method development in a pharmaceutical QbD environment. Am. Pharm. Rev. May 2009, 12(4).
-
(2009)
Am. Pharm. Rev.
, vol.12
, Issue.4
-
-
Li, Y.1
Terfloth, G.J.2
Kord, A.S.3
-
22
-
-
53649084220
-
Computer-assisted optimization of liquid chromatography separations of drugs and related substances
-
Baczek T. Computer-assisted optimization of liquid chromatography separations of drugs and related substances. Curr. Pharm. Anal. 2008, 4:151-161.
-
(2008)
Curr. Pharm. Anal.
, vol.4
, pp. 151-161
-
-
Baczek, T.1
-
23
-
-
66849119098
-
Application of gradient elution optimized by Chromsword software in chromatography of phenothiazines in reversed phase systems controlled by chaotropic effect
-
Flieger J., Markowski W. Application of gradient elution optimized by Chromsword software in chromatography of phenothiazines in reversed phase systems controlled by chaotropic effect. Chem. Anal. 2009, 54:187-202.
-
(2009)
Chem. Anal.
, vol.54
, pp. 187-202
-
-
Flieger, J.1
Markowski, W.2
-
24
-
-
70349801683
-
Rapid high performance liquid chromatography method development with high prediction accuracy, using 5 cm long narrow bore columns packed with sub-2 μm particles and Design Space computer modeling
-
Fekete S., Fekete J., Molnár I., Ganzler K. Rapid high performance liquid chromatography method development with high prediction accuracy, using 5 cm long narrow bore columns packed with sub-2 μm particles and Design Space computer modeling. J. Chromatogr. A 2009, 1216:7816-7823.
-
(2009)
J. Chromatogr. A
, vol.1216
, pp. 7816-7823
-
-
Fekete, S.1
Fekete, J.2
Molnár, I.3
Ganzler, K.4
-
25
-
-
0035089518
-
Guidance for robustness/ruggedness tests in method validation
-
Vander Heyden Y., Nijhuis A., Smeyers-Verbeke J., Vandeginste B.G.M., Massart D.L. Guidance for robustness/ruggedness tests in method validation. J. Pharm. Biomed. Anal. 2001, 24:723-754.
-
(2001)
J. Pharm. Biomed. Anal.
, vol.24
, pp. 723-754
-
-
Vander Heyden, Y.1
Nijhuis, A.2
Smeyers-Verbeke, J.3
Vandeginste, B.G.M.4
Massart, D.L.5
-
26
-
-
78649956368
-
-
Wiley-VCH, Weinheim, J. Ermer, J.H.M. Miller (Eds.)
-
Kleinschmidt G. Robustness 2005, 120-127. Wiley-VCH, Weinheim. J. Ermer, J.H.M. Miller (Eds.).
-
(2005)
Robustness
, pp. 120-127
-
-
Kleinschmidt, G.1
-
27
-
-
70349163605
-
Development and validation of a stability indicating LC method for the assay and related substances determination of Exemestane, an aromatase inhibitor
-
Suresh Kumar R., Narasimha Naidu M., Srinivasulu K., Raja Sekhar K., Veerender M., Srinivasu M.K. Development and validation of a stability indicating LC method for the assay and related substances determination of Exemestane, an aromatase inhibitor. J. Pharm. Biomed. Anal. 2009, 50:746-752.
-
(2009)
J. Pharm. Biomed. Anal.
, vol.50
, pp. 746-752
-
-
Suresh Kumar, R.1
Narasimha Naidu, M.2
Srinivasulu, K.3
Raja Sekhar, K.4
Veerender, M.5
Srinivasu, M.K.6
-
28
-
-
70349566002
-
Development and validation of a rapid RP-HPLC method for the determination of venlafaxine hydrochloride in pharmaceutical dosage forms using experimental design
-
Somasekhar V., Gowrisankar D., Shivakumar H.N. Development and validation of a rapid RP-HPLC method for the determination of venlafaxine hydrochloride in pharmaceutical dosage forms using experimental design. E-J. Chem. October 2009, 6(4):1091-1102.
-
(2009)
E-J. Chem.
, vol.6
, Issue.4
, pp. 1091-1102
-
-
Somasekhar, V.1
Gowrisankar, D.2
Shivakumar, H.N.3
-
29
-
-
70349286267
-
Regulatory requirement-Validated, specific, and stability indicating analytical method for zoledronic acid and its related impurities by Ion Pair reversed phase liquid chromatography (IP-RPLC)
-
Nandan S.R., Reddy R., Rao S., Ravindranath L.K. Regulatory requirement-Validated, specific, and stability indicating analytical method for zoledronic acid and its related impurities by Ion Pair reversed phase liquid chromatography (IP-RPLC). J. Liq. Chromatogr. Relat. Technol. 2009, 32:2307-2321.
-
(2009)
J. Liq. Chromatogr. Relat. Technol.
, vol.32
, pp. 2307-2321
-
-
Nandan, S.R.1
Reddy, R.2
Rao, S.3
Ravindranath, L.K.4
-
30
-
-
67649868327
-
Development of robust quantitative methods by near-infrared spectroscopy for rapid pharmaceutical determination of content uniformity in complex tablet matrix
-
Xiang D., Konigsberger M., Wabuyele B., Hornung K., Cheney J. Development of robust quantitative methods by near-infrared spectroscopy for rapid pharmaceutical determination of content uniformity in complex tablet matrix. Analyst 2009, 134:1405-1415.
-
(2009)
Analyst
, vol.134
, pp. 1405-1415
-
-
Xiang, D.1
Konigsberger, M.2
Wabuyele, B.3
Hornung, K.4
Cheney, J.5
-
31
-
-
0032433807
-
Robustness testing of a liquid chromatography method for the determination of Vorozole and its related compounds in oral tablets
-
Jimidai M., Niemeijer N., Peeters R., Hoogmartens J. Robustness testing of a liquid chromatography method for the determination of Vorozole and its related compounds in oral tablets. J. Pharm. Biomed. Anal. 1998, 18:479M85.
-
(1998)
J. Pharm. Biomed. Anal.
, vol.18
-
-
Jimidai, M.1
Niemeijer, N.2
Peeters, R.3
Hoogmartens, J.4
-
33
-
-
0029022099
-
-
Jimidar I.M., Hartmann C., Cousement N., Massart D.L. J. Chromatogr. A 1995, 706:479.
-
(1995)
J. Chromatogr. A
, vol.706
, pp. 479
-
-
Jimidar, I.M.1
Hartmann, C.2
Cousement, N.3
Massart, D.L.4
-
34
-
-
0026096010
-
System suitability in an optimized HPLC system
-
Wiggins D.E. System suitability in an optimized HPLC system. J. Liq. Chromatogr. 1991, 14:1045-1060.
-
(1991)
J. Liq. Chromatogr.
, vol.14
, pp. 1045-1060
-
-
Wiggins, D.E.1
-
35
-
-
0025609192
-
E Chromatographic system suitability; tests: What should we be using?
-
Wahlich J.C., Carr G. E Chromatographic system suitability; tests: What should we be using?. J. Pharm. Biomed. Anal. 1990, 8:619-623.
-
(1990)
J. Pharm. Biomed. Anal.
, vol.8
, pp. 619-623
-
-
Wahlich, J.C.1
Carr, G.2
-
36
-
-
78649944002
-
-
USP 32 NF 27 United States Pharmacopoeial Convention, Inc.: Roskville, MD.
-
USP 32 NF 27 United States Pharmacopoeial Convention, Inc.: Roskville, MD, 2009.
-
(2009)
-
-
-
37
-
-
0004251768
-
-
EP, The European Directorate for the Quality of Medicines within the Council of Europe, Strasbourg
-
European Pharmacopoeia 2010, EP, The European Directorate for the Quality of Medicines within the Council of Europe, Strasbourg. 6th ed.
-
(2010)
European Pharmacopoeia
-
-
-
39
-
-
0034103410
-
Development and validation of automated methods for finished product testing
-
Walsh A., et al. Development and validation of automated methods for finished product testing. Pharm. Technol. Eur. May 2000.
-
(2000)
Pharm. Technol. Eur.
-
-
Walsh, A.1
-
40
-
-
0006153323
-
Master method validation protocols
-
DeSain C. Master method validation protocols. BioPharm 1992, 6:30-34.
-
(1992)
BioPharm
, vol.6
, pp. 30-34
-
-
DeSain, C.1
-
42
-
-
18144423086
-
Validation in pharmaceutical analysis Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data
-
Ermer J., Ploss H.-J. Validation in pharmaceutical analysis Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data. J. Pharm. Biomed. Anal. 2005, 37:859-870.
-
(2005)
J. Pharm. Biomed. Anal.
, vol.37
, pp. 859-870
-
-
Ermer, J.1
Ploss, H.-J.2
-
43
-
-
33744468797
-
Automation of the chromatographic analytical method validation process
-
Lukulay P., Morgado J. Automation of the chromatographic analytical method validation process. LCGC North Am. 2006, 24(2):151-156.
-
(2006)
LCGC North Am.
, vol.24
, Issue.2
, pp. 151-156
-
-
Lukulay, P.1
Morgado, J.2
-
44
-
-
0001229909
-
A practical guide to analytical method validation
-
Green J.M. A practical guide to analytical method validation. Anal. Chem. 1996, 68:305A-309A.
-
(1996)
Anal. Chem.
, vol.68
-
-
Green, J.M.1
-
45
-
-
0029878139
-
Chromatographic method validation: A review of current practices and procedures II. Guidelines for primary validation parameters
-
Jenke D.R. Chromatographic method validation: A review of current practices and procedures II. Guidelines for primary validation parameters. J. Liq. Chromatogr. Relat. Technol. 1996, 19:737-757.
-
(1996)
J. Liq. Chromatogr. Relat. Technol.
, vol.19
, pp. 737-757
-
-
Jenke, D.R.1
-
46
-
-
0011236397
-
A life cycle approach to the validation of analytical methods during pharmaceutical product Development II. Changes and the need for additional validation
-
Hokanson G.C. A life cycle approach to the validation of analytical methods during pharmaceutical product Development II. Changes and the need for additional validation. Pharm. Technol. 1994, I8:92-100.
-
(1994)
Pharm. Technol.
, vol.I8
, pp. 92-100
-
-
Hokanson, G.C.1
-
47
-
-
78649960411
-
-
PMA Analytical Steering Committee, Washington, DC
-
PMA Workshop on Reference Standards 1992, PMA Analytical Steering Committee, Washington, DC.
-
(1992)
PMA Workshop on Reference Standards
-
-
-
48
-
-
78649979576
-
Bulk drug substances and finished products
-
Pergamon, Oxford, UK, C.M. Riley, T.W. Rpsanke (Eds.)
-
Housepian P.K. Bulk drug substances and finished products. Development and Validation of Analytical Methods 1996, Pergamon, Oxford, UK. C.M. Riley, T.W. Rpsanke (Eds.).
-
(1996)
Development and Validation of Analytical Methods
-
-
Housepian, P.K.1
-
49
-
-
78649922876
-
-
FDA guidelines for supporting documentation in drug applications for the manufacturing of drug substances.
-
FDA guidelines for supporting documentation in drug applications for the manufacturing of drug substances, 1987.
-
(1987)
-
-
|