-
2
-
-
0013809730
-
Physical and chemical stability of tablet dosage form
-
Lachman, L. Physical and chemical stability of tablet dosage form. J. Pharm. Sci., 1965, 54(10), 1519-1526.
-
(1965)
J. Pharm. Sci
, vol.54
, Issue.10
, pp. 1519-1526
-
-
Lachman, L.1
-
3
-
-
1842589489
-
Physical stability of pharmaceuticals
-
Tingstad, J.E. Physical stability of pharmaceuticals. J. Pharm. Sci., 1964, 53(8), 955-962.
-
(1964)
J. Pharm. Sci
, vol.53
, Issue.8
, pp. 955-962
-
-
Tingstad, J.E.1
-
4
-
-
17444394136
-
-
Gennaro, A.R., Ed., Lippincott Williams and Wilkins: Philadelphia
-
Vadas, E.B. In Remington: The Science and Practice of Pharmacy; Gennaro, A.R., Ed.; Lippincott Williams and Wilkins: Philadelphia, 2000; Vol.1, pp. 986-994.
-
(2000)
Remington: The Science and Practice of Pharmacy
, vol.1
, pp. 986-994
-
-
Vadas, E.B.1
-
6
-
-
0346206655
-
-
Lachman, L.; Lieberman, H.A.; Kanig, J.L., Ed.; Varghese Publishing House: Bombay
-
Lachman, L.; Deluca, P.; Akers, M.J. In Theory and Practice of Industrial Pharmacy; Lachman, L.; Lieberman, H.A.; Kanig, J.L., Ed.; Varghese Publishing House: Bombay, 1986; pp.760-795.
-
(1986)
Theory and Practice of Industrial Pharmacy
, pp. 760-795
-
-
Lachman, L.1
Deluca, P.2
Akers, M.J.3
-
7
-
-
84856974125
-
-
Aulton M.E., Ed.; Churchill Livingstone Harcourt: London
-
Pugh, J. In Pharmaceutics: The science of dosage form design; Aulton M.E., Ed.; Churchill Livingstone Harcourt: London, 2002; pp.101-112.
-
(2002)
Pharmaceutics: The Science of Dosage Form Design
, pp. 101-112
-
-
Pugh, J.1
-
10
-
-
15044340742
-
Accelerated aging: Prediction of chemical stability of pharmaceuticals
-
Waterman, K.C.; Adami, R.C. Accelerated aging: Prediction of chemical stability of pharmaceuticals. Int. J. Pharm., 2005, 293(1-2), 101-125.
-
(2005)
Int. J. Pharm
, vol.293
, Issue.1-2
, pp. 101-125
-
-
Waterman, K.C.1
Adami, R.C.2
-
11
-
-
0003716532
-
-
FDA, Guidance for Industry, Rockville, MD, Available at
-
FDA, Guidance for Industry: Stability Testing of Drug Substances and Drug Products. Rockville, MD, 1998, Available at http://www.fda/cder/guidance/index.html
-
(1998)
Stability Testing of Drug Substances and Drug Products
-
-
-
13
-
-
0021741005
-
Stability of solid and disperse systems
-
Carstensen, J.T. Stability of solid and disperse systems. Drug Develop. Ind. Pharm., 1984, 10(8), 1277-1296.
-
(1984)
Drug Develop. Ind. Pharm
, vol.10
, Issue.8
, pp. 1277-1296
-
-
Carstensen, J.T.1
-
14
-
-
29644432966
-
-
Banker, G.S.; Rhodes, C.T., Ed.; Marcel Dekker: New York
-
Guillory, J.K.; Poust, R.I. In Modern Pharmaceutics; Banker, G.S.; Rhodes, C.T., Ed.; Marcel Dekker: New York, 2002; pp.139-163.
-
(2002)
In Modern Pharmaceutics
, pp. 139-163
-
-
Guillory, J.K.1
Poust, R.I.2
-
15
-
-
0018151966
-
Stability of pharmaceuticals
-
Mollica, J.A.; Ahuja, S.; Cohen, J. Stability of pharmaceuticals. J. Pharm. Sci., 1978, 67(4), 443-465.
-
(1978)
J. Pharm. Sci
, vol.67
, Issue.4
, pp. 443-465
-
-
Mollica, J.A.1
Ahuja, S.2
Cohen, J.3
-
17
-
-
0026567141
-
Practical testing of solid state stability of pharmaceuticals
-
Chafetz, L. Practical testing of solid state stability of pharmaceuticals. J. Pharm. Sci., 1992, 81(1), 107.
-
(1992)
J. Pharm. Sci
, vol.81
, Issue.1
, pp. 107
-
-
Chafetz, L.1
-
18
-
-
0025029135
-
Rational storage conditions for accelerated testing of stability of solid pharmaceuticals
-
Yoshioka, S.; Carstensen, J.T. Rational storage conditions for accelerated testing of stability of solid pharmaceuticals. J. Pharm. Sci., 1990, 79(10), 943-944.
-
(1990)
J. Pharm. Sci
, vol.79
, Issue.10
, pp. 943-944
-
-
Yoshioka, S.1
Carstensen, J.T.2
-
19
-
-
33748358671
-
Prediction of stability of drugs and pharmaceutical preparations
-
Garrett, E.R. Prediction of stability of drugs and pharmaceutical preparations. J. Pharm. Sci., 1962, 51(9), 811-833.
-
(1962)
J. Pharm. Sci
, vol.51
, Issue.9
, pp. 811-833
-
-
Garrett, E.R.1
-
20
-
-
0021714047
-
Stability aspects of preformulation and formulation of solid pharmaceuticals
-
Monkhouse, D.C. Stability aspects of preformulation and formulation of solid pharmaceuticals. Drug Develop. Ind. Pharm., 1984, 10(8), 1373-1412.
-
(1984)
Drug Develop. Ind. Pharm
, vol.10
, Issue.8
, pp. 1373-1412
-
-
Monkhouse, D.C.1
-
21
-
-
0021714048
-
Stability programs for formulation studies
-
Dukes, G.R. Stability programs for formulation studies. Drug Develop. Ind. Pharm., 1984, 10(8), 1413-1424.
-
(1984)
Drug Develop. Ind. Pharm
, vol.10
, Issue.8
, pp. 1413-1424
-
-
Dukes, G.R.1
-
22
-
-
79959538236
-
-
Ahuja, S.; Dong, M.W., Ed.; Elsevier Academic Press: San Diego
-
Wong, A.W.; Datla, A. In Hand Book of Pharmaceutical Analysis by HPLC, Ahuja, S.; Dong, M.W., Ed.; Elsevier Academic Press: San Diego, 2005, pp. 335-358.
-
(2005)
In Hand Book of Pharmaceutical Analysis By HPLC
, pp. 335-358
-
-
Wong, A.W.1
Datla, A.2
-
23
-
-
23644446012
-
Guidelines from the International Conference on Harmonization
-
Branch, S.K., Guidelines from the International Conference on Harmonization. J. Pharm. Biomed. Anal., 2005, 38(5), 798-805.
-
(2005)
J. Pharm. Biomed. Anal
, vol.38
, Issue.5
, pp. 798-805
-
-
Branch, S.K.1
-
28
-
-
33846566680
-
Comparison of various International guidelines for analytical method validation
-
Chandran S.; Singh R.S.P. Comparison of various International guidelines for analytical method validation. Pharmazie, 2007, 62(1), 4-14.
-
(2007)
Pharmazie
, vol.62
, Issue.1
, pp. 4-14
-
-
Chandran, S.1
Singh, R.S.P.2
-
30
-
-
0037097780
-
Development of stability-indicating assay methods
-
Singh, S.; Bakshi, M. Development of stability-indicating assay methods. J. Pharm. Biomed. Anal; 2002, 28(6), 1011-1040.
-
(2002)
J. Pharm. Biomed. Anal
, vol.28
, Issue.6
, pp. 1011-1040
-
-
Singh, S.1
Bakshi, M.2
-
31
-
-
33645774705
-
Importance of impurity analysis in pharmaceutical products. Accred. Qual
-
Rahman, N.; Azmi, S. N. H.; Wu, H. N. Importance of impurity analysis in pharmaceutical products. Accred. Qual. Assur.; 2006, 11(2), 69-74.
-
(2006)
Assur
, vol.11
, Issue.2
, pp. 69-74
-
-
Rahman, N.1
Azmi, S.N.H.2
Wu, H.N.3
-
34
-
-
0025222760
-
Liquid chroma-tographic considerations for high sensitivity impurity and stability testing of pharmaceuticals
-
Dong, M.W.; Passalacqua, P.V.; Choudhary, D.R. Liquid chroma-tographic considerations for high sensitivity impurity and stability testing of pharmaceuticals. J. Liq. Chromatogr. Related Technol., 1990, 13(11), 2135-2160.
-
(1990)
J. Liq. Chromatogr. Related Technol
, vol.13
, Issue.11
, pp. 2135-2160
-
-
Dong, M.W.1
Passalacqua, P.V.2
Choudhary, D.R.3
-
36
-
-
0002990443
-
Guidance on conduct of stress tests to determine inherent stability of drugs
-
Singh, S.; Bakshi, M. Guidance on conduct of stress tests to determine inherent stability of drugs. Pharm. Technol., 2000, 24, 1-14.
-
(2000)
Pharm. Technol
, vol.24
, pp. 1-14
-
-
Singh, S.1
Bakshi, M.2
-
37
-
-
0036178655
-
Available guidance and best practices for conducting forced degradation studies
-
Reynolds, D.W. Available guidance and best practices for conducting forced degradation studies. Pharm. Technol., 2002, 26(2), 48-56.
-
(2002)
Pharm. Technol
, vol.26
, Issue.2
, pp. 48-56
-
-
Reynolds, D.W.1
-
38
-
-
0041819811
-
A stress testing benchmarking study
-
Alsante, K. M.; Martin, L.; Baertschi, S.W. A stress testing benchmarking study. Pharm. Technol., 2003, 27(2), 60-72.
-
(2003)
Pharm. Technol
, vol.27
, Issue.2
, pp. 60-72
-
-
Alsante, K.M.1
Martin, L.2
Baertschi, S.W.3
-
39
-
-
0030249373
-
Predictive strategy for the rapid structure elucidation of drug de-gradants
-
Rourick, R.A.; Volk, K.J.; Klohr S.E.; Kerns E.H.; Lee, M.S. Predictive strategy for the rapid structure elucidation of drug de-gradants. J. Pharm. Biomed. Anal., 1996, 14(12), 1743-1752.
-
(1996)
J. Pharm. Biomed. Anal
, vol.14
, Issue.12
, pp. 1743-1752
-
-
Rourick, R.A.1
Volk, K.J.2
Klohr, S.E.3
Kerns, E.H.4
Lee, M.S.5
-
41
-
-
0008356051
-
Photostability testing of pharmaceutical products
-
Sager, N.; Baum, R.; Wolters, R.; Layloff, T. Photostability testing of pharmaceutical products. Pharmacopoeial Forum, 1998, 24(3), 6331-6333.
-
(1998)
Pharmacopoeial Forum
, vol.24
, Issue.3
, pp. 6331-6333
-
-
Sager, N.1
Baum, R.2
Wolters, R.3
Layloff, T.4
-
42
-
-
0021738763
-
Stability aspects of packaging
-
Dean, D.A. Stability aspects of packaging. Drug Develop. Ind. Pharm., 1984, 10(8), 1463-1495.
-
(1984)
Drug Develop. Ind. Pharm
, vol.10
, Issue.8
, pp. 1463-1495
-
-
Dean, D.A.1
-
43
-
-
0035912927
-
The effects of packaging on the stability of a moisture sensitive compound
-
Allinson, J.G.; Dansereau, R.J.; Sakr, A. The effects of packaging on the stability of a moisture sensitive compound. Int. J. Pharm., 2001, 221(2), 49-56.
-
(2001)
Int. J. Pharm
, vol.221
, Issue.2
, pp. 49-56
-
-
Allinson, J.G.1
Dansereau, R.J.2
Sakr, A.3
-
44
-
-
77952939892
-
-
International Conference on Harmonization, Available at
-
International Conference on Harmonization. ICH Q1E: Evaluation for stability data, 2003, Available at http://www.ich.org/LOB/me-dia/me dia415.pdf
-
(2003)
ICH Q1E: Evaluation For Stability Data
-
-
-
46
-
-
33646597308
-
A risk based approach to establish stability testing conditions for tropical countries
-
Zahl, M. A risk based approach to establish stability testing conditions for tropical countries. J. Pharm. Sci., 2006, 95(5), 946-965.
-
(2006)
J. Pharm. Sci
, vol.95
, Issue.5
, pp. 946-965
-
-
Zahl, M.1
-
47
-
-
0015070226
-
Worldwide virtual temperatures for product stability testing
-
Haynes, J.D. Worldwide virtual temperatures for product stability testing. J. Pharm. Sci., 1971, 60(6), 927-929.
-
(1971)
J. Pharm. Sci
, vol.60
, Issue.6
, pp. 927-929
-
-
Haynes, J.D.1
-
48
-
-
34249298342
-
Storage conditions for stability testing of pharmaceuticals in hot and humid regions
-
Bott, R. F.; Oliveira, W. P. Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug Develop. Ind. Pharm., 2007, 33(4), 393-401.
-
(2007)
Drug Develop. Ind. Pharm
, vol.33
, Issue.4
, pp. 393-401
-
-
Bott, R.F.1
Oliveira, W.P.2
-
49
-
-
0033051354
-
Trends in stability testing with emphasis on stability during distribution and storage
-
Kommanaboyina, B.; Rhodes, C.T. Trends in stability testing with emphasis on stability during distribution and storage. Drug Develop. Ind. Pharm., 1999, 25(7), 857-868.
-
(1999)
Drug Develop. Ind. Pharm
, vol.25
, Issue.7
, pp. 857-868
-
-
Kommanaboyina, B.1
Rhodes, C.T.2
-
50
-
-
0041633675
-
Overview of stability study designs
-
Lin, T.D.; Chen, C.W. Overview of stability study designs. J. Bio-pharm. Statist., 2003, 13(3), 337-354.
-
(2003)
J. Bio-pharm. Statist
, vol.13
, Issue.3
, pp. 337-354
-
-
Lin, T.D.1
Chen, C.W.2
-
51
-
-
77952926430
-
Stability testing of pharmaceuticals
-
Paranjothy, K.L.K; Agarwal, P.K. Stability testing of pharmaceuticals. Indian Drugs, 1980, 17(4), 114-119.
-
(1980)
Indian Drugs
, vol.17
, Issue.4
, pp. 114-119
-
-
Paranjothy, K.L.K.1
Agarwal, P.K.2
-
52
-
-
0033014363
-
Regulatory aspects of stability testing in Europe
-
Mathews, B.R. Regulatory aspects of stability testing in Europe. Drug Develop. Ind. Pharm., 1999, 25(7), 831-856.
-
(1999)
Drug Develop. Ind. Pharm
, vol.25
, Issue.7
, pp. 831-856
-
-
Mathews, B.R.1
-
53
-
-
0021683050
-
Stability programs for marketed batches
-
Kaminski, E.E. Stability programs for marketed batches. Drug Develop. Ind. Pharm., 1984, 10(8), 1433-1448.
-
(1984)
Drug Develop. Ind. Pharm
, vol.10
, Issue.8
, pp. 1433-1448
-
-
Kaminski, E.E.1
-
54
-
-
0028790317
-
Regulatory, design and analysis aspects of complex stability studies
-
Fairweather, W.; Lin, T.D.; Kelly, R. Regulatory, design and analysis aspects of complex stability studies. J. Pharm. Sci., 1995, 84(11), 1322-1326.
-
(1995)
J. Pharm. Sci
, vol.84
, Issue.11
, pp. 1322-1326
-
-
Fairweather, W.1
Lin, T.D.2
Kelly, R.3
-
56
-
-
0021689478
-
An overview of kinetics for the evaluation of the stability of pharmaceutical systems
-
Rhodes, C.T. An overview of kinetics for the evaluation of the stability of pharmaceutical systems. Drug Develop. Ind. Pharm., 1984, 10(8), 1163-1174.
-
(1984)
Drug Develop. Ind. Pharm
, vol.10
, Issue.8
, pp. 1163-1174
-
-
Rhodes, C.T.1
-
57
-
-
0027729243
-
Storage conditions for the most important market for drug products including EU, Japan and the USA
-
Grimm, W. Storage conditions for the most important market for drug products including EU, Japan and the USA. Drug Develop. Ind. Pharm., 1993, 19(20), 2795-2830.
-
(1993)
Drug Develop. Ind. Pharm
, vol.19
, Issue.20
, pp. 2795-2830
-
-
Grimm, W.1
-
58
-
-
0025273988
-
Accelerated temperature pharmaceutical product stability determinations
-
Young, W.R. Accelerated temperature pharmaceutical product stability determinations. Drug Develop. Ind. Pharm. 1990, 16(4), 551-569.
-
(1990)
Drug Develop. Ind. Pharm
, vol.16
, Issue.4
, pp. 551-569
-
-
Young, W.R.1
-
59
-
-
0031954253
-
Extension of ICH Tripartite Guideline for stability testing of new drug substances and products to countries of climatic zones III and IV
-
Grimm, W. Extension of ICH Tripartite Guideline for stability testing of new drug substances and products to countries of climatic zones III and IV. Drug Develop. Ind. Pharm., 1998, 24(4), 313-325.
-
(1998)
Drug Develop. Ind. Pharm
, vol.24
, Issue.4
, pp. 313-325
-
-
Grimm, W.1
-
60
-
-
33947377469
-
-
Available at
-
ASEAN Guidelines on stability study of drug product, 2005, Available at http://www.hsa.gov.sg/publish/etc/medialib/hsa_li-brary/health_products_regulation/western_medicines/files_guidelin es
-
(2005)
ASEAN Guidelines On Stability Study of Drug Product
-
-
-
61
-
-
35548988294
-
Recent developments on long term stability test conditions
-
Singh, S.; Kumar, V. Recent developments on long term stability test conditions. The Pharma Review, 2006, 4(24), 61-68.
-
(2006)
The Pharma Review
, vol.4
, Issue.24
, pp. 61-68
-
-
Singh, S.1
Kumar, V.2
-
63
-
-
0347652957
-
Okuliar, New screening method for the determination of stability of pharmaceuticals
-
Simon, P.; Veverka, M.; Okuliar, New screening method for the determination of stability of pharmaceuticals, Int. J. Pharm., 2004, 270(2), 21-26.
-
(2004)
Int. J. Pharm
, vol.270
, Issue.2
, pp. 21-26
-
-
Simon, P.1
Veverka, M.2
-
64
-
-
0022460092
-
Stability testing in industry for worldwide marketing
-
Grimm, W. Stability testing in industry for worldwide marketing, Drug Develop. Ind. Pharm., 1986, 12(8), 1259-1292.
-
(1986)
Drug Develop. Ind. Pharm
, vol.12
, Issue.8
, pp. 1259-1292
-
-
Grimm, W.1
|