-
1
-
-
0033960637
-
Necessity and requirements of bridging studies and their present status in Japan
-
Naito C. Necessity and requirements of bridging studies and their present status in Japan. Int J Clin Pharmacol Ther. 2000;38:80-86.
-
(2000)
Int J Clin Pharmacol Ther
, vol.38
, pp. 80-86
-
-
Naito, C.1
-
2
-
-
33750865918
-
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use
-
Geneva, Switzerland: International Conference on Harmonisation
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Ethnic Factors for the Acceptability of Foreign Clinical Data (E5). Geneva, Switzerland: International Conference on Harmonisation; 1996.
-
(1996)
ICH Harmonised Tripartite Guideline: Ethnic Factors for the Acceptability of Foreign Clinical Data (E5)
-
-
-
3
-
-
0036379958
-
Assessment of extrapolation of foreign clinical data as a basis for registration purposes
-
Lin YL, Chiou YJ, Hsiao CL, et al. Assessment of extrapolation of foreign clinical data as a basis for registration purposes. Drug Inf J. 2002;36:513-156.
-
(2002)
Drug Inf J
, vol.36
, pp. 513-1156
-
-
Lin, Y.L.1
Chiou, Y.J.2
Hsiao, C.L.3
-
4
-
-
0142214731
-
Taiwan's experience with the assessment of the acceptability of the extrapolation of foreign clinical data for registration purposes
-
Lin YL, Chern HD, Chu ML. Taiwan's experience with the assessment of the acceptability of the extrapolation of foreign clinical data for registration purposes. Drug Inf J. 2003;37:143-145.
-
(2003)
Drug Inf J
, vol.37
, pp. 143-145
-
-
Lin, Y.L.1
Chern, H.D.2
Chu, M.L.3
-
7
-
-
84872866961
-
-
Available at. Accessed September 23, 2004
-
US Food and Drug Administration. Guidance for industry-premarketing risk assessment. Available at: http://www.fda.gov/cder/guidance/5765dft.pdf. Accessed September 23, 2004.
-
Guidance for Industry-Premarketing Risk Assessment
-
-
-
9
-
-
0027531892
-
Serevent nationwide surveillance study: Comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment
-
Castle W, Fuller R, Hall J, et al. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ. 1993;306:1034-1037.
-
(1993)
BMJ
, vol.306
, pp. 1034-1037
-
-
Castle, W.1
Fuller, R.2
Hall, J.3
-
10
-
-
4444275272
-
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use
-
Geneva, Switzerland: International Conference on Harmonisation
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Choice of Control Group and Related Issues in Clinical Trials (E10). Geneva, Switzerland: International Conference on Harmonisation; 2000.
-
(2000)
ICH Harmonised Tripartite Guideline: Choice of Control Group and Related Issues in Clinical Trials (E10)
-
-
-
11
-
-
0034121667
-
Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis: A randomized, controlled, double-blind, placebo-controlled trial
-
Hawkey C, Laine L, Simon T, et al. Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis: a randomized, controlled, double-blind, placebo-controlled trial. Arthritis Rheum. 2000;43:370-377.
-
(2000)
Arthritis Rheum
, vol.43
, pp. 370-377
-
-
Hawkey, C.1
Laine, L.2
Simon, T.3
-
12
-
-
0034707105
-
Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis
-
Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343:1520-1528.
-
(2000)
N Engl J Med
, vol.343
, pp. 1520-1528
-
-
Bombardier, C.1
Laine, L.2
Reicin, A.3
-
13
-
-
33750855798
-
Thiazolidine-dione-associated 15-month postmarketing hepatotoxicity
-
Available at. Accessed November 18, 2004
-
Zawadzki JK, Green L, Graham DJ. Thiazolidine-dione-associated 15-month postmarketing hepatotoxicity. FDA Science Forum. Available at: http://www.cfsan.fda.gov/~frf/forum02/a187ab 4.htm. Accessed November 18, 2004.
-
FDA Science Forum
-
-
Zawadzki, J.K.1
Green, L.2
Graham, D.J.3
-
14
-
-
0031819810
-
Serum transaminase elevations as indicators of hepatic injury administration of drugs
-
Amacher DE. Serum transaminase elevations as indicators of hepatic injury administration of drugs. Regul Toxicol Pharmacol. 1998;27:119-130.
-
(1998)
Regul Toxicol Pharmacol
, vol.27
, pp. 119-130
-
-
Amacher, D.E.1
-
16
-
-
0033045249
-
The natural history of histologically proved drug induced liver disease
-
Aithal PG, Day CP. The natural history of histologically proved drug induced liver disease. Gut. 1999;44:731-735.
-
(1999)
Gut
, vol.44
, pp. 731-735
-
-
Aithal, P.G.1
Day, C.P.2
-
17
-
-
0038385271
-
Hepatotoxicity associated with non-steroidal anti-inflammatory drugs
-
Teoh NC, Farrell GC. Hepatotoxicity associated with non-steroidal anti-inflammatory drugs. Clin Liver Dis. 2003;7:401-413.
-
(2003)
Clin Liver Dis
, vol.7
, pp. 401-413
-
-
Teoh, N.C.1
Farrell, G.C.2
-
18
-
-
0037709247
-
Hepatotoxicity of the thiazolidinediones
-
Tolman GK, Chandramouli J. Hepatotoxicity of the thiazolidinediones. Clin Liver Dis. 2003;7:369-379.
-
(2003)
Clin Liver Dis
, vol.7
, pp. 369-379
-
-
Tolman, G.K.1
Chandramouli, J.2
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