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Items: 1 to 20 of 82

1.

Critical review of 'Public domain application': a flexible drug approval system in Japan.

Ito Y, Narimatsu H, Fukui T, Fukao A, Yoshioka T.

Ann Oncol. 2013 May;24(5):1297-305. doi: 10.1093/annonc/mdt020. Epub 2013 Mar 25.

PMID:
23532113
2.
3.

Japanese regulatory system for approval of off-label drug use: evaluation of safety and effectiveness in literature-based applications.

Shimazawa R, Ikeda M.

Clin Ther. 2012 Oct;34(10):2104-16. doi: 10.1016/j.clinthera.2012.09.004. Epub 2012 Oct 2.

PMID:
23036337
4.

Treatment of relapsed aggressive lymphomas: regimens with and without high-dose therapy and stem cell rescue.

Hagemeister FB.

Cancer Chemother Pharmacol. 2002 May;49 Suppl 1:S13-20. Epub 2002 Apr 12. Review.

PMID:
12042984
5.

INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.

[No authors listed]

Drugs R D. 2007;8(3):176-87. Review.

PMID:
17472413
6.

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

DiMasi JA.

Clin Ther. 2013 Jun;35(6):808-18. doi: 10.1016/j.clinthera.2013.04.004. Epub 2013 May 28.

PMID:
23726388
7.

Potential factors correlating to the PMDA's decision to waive Japanese Phase 2 and 3 studies for oncology drugs New Drug Application in Japan.

Nakajima K, Chiba K, Tsubamoto H, Walsh J, Strawn L, Suwa T.

Invest New Drugs. 2013 Aug;31(4):1051-5. doi: 10.1007/s10637-012-9911-x. Epub 2012 Dec 19.

PMID:
23250712
8.

European experience with ifosfamide in lymphomas.

von Kalle AK, Schaadt M, Diehl V.

Semin Oncol. 1989 Feb;16(1 Suppl 3):73-7. Review.

PMID:
2468184
9.

Approving molecularly targeted drugs: different approval processes for cytotoxic agents.

Sasahara Y, Narimatsu H, Fukao A, Yoshioka T.

Int J Clin Oncol. 2016 Oct;21(5):1004-1013. Epub 2016 Apr 22.

PMID:
27105626
10.

Acceptance of surrogate end points in clinical trials supporting approval of drugs for cancer treatment by the Japanese regulatory agency.

Maeda H, Kurokawa T.

Ann Oncol. 2015 Jan;26(1):211-6. doi: 10.1093/annonc/mdu500. Epub 2014 Oct 30.

PMID:
25361994
11.

Erlotinib: CP 358774, NSC 718781, OSI 774, R 1415.

Adis International Ltd.

Drugs R D. 2003;4(4):243-8.

PMID:
12848590
12.

Advances in chemotherapy for large cell lymphoma.

Coleman M, Gerstein G, Topilow A, Lebowicz J, Berhardt B, Chiarieri D, Silver RT, Pasmantier MW.

Semin Hematol. 1987 Apr;24(2 Suppl 1):8-20.

PMID:
2438781
13.
15.

[Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].

Pflieger M, Bertram D.

Arch Pediatr. 2014 Oct;21(10):1129-38. doi: 10.1016/j.arcped.2014.07.011. Epub 2014 Aug 28. French.

PMID:
25175054
16.

Comparative activity of cisplatin, ifosfamide, doxorubicin, carboplatin, and etoposide in heterotransplanted hepatoblastoma.

Fuchs J, Wenderoth M, von Schweinitz D, Haindl J, Leuschner I.

Cancer. 1998 Dec 1;83(11):2400-7.

PMID:
9840541
17.

Development of drug-approval regulations for medical countermeasures against CBRN agents in Japan.

Shimazawa R, Ikeda M.

Health Secur. 2015 Mar-Apr;13(2):130-8. Epub 2015 Mar 25.

PMID:
25813978
18.

Exisulind: Aptosyn, FGN 1, Prevatac, sulindac sulfone.

[No authors listed]

Drugs R D. 2004;5(4):220-6. Review.

PMID:
15230629
19.

Approval probabilities and regulatory review patterns for anticancer drugs in the European Union.

Hartmann M, Mayer-Nicolai C, Pfaff O.

Crit Rev Oncol Hematol. 2013 Aug;87(2):112-21. doi: 10.1016/j.critrevonc.2013.01.004. Epub 2013 Feb 20. Review.

PMID:
23433721
20.

Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects.

Kuribayashi R, Matsuhama M, Mikami K.

AAPS J. 2015 Sep;17(5):1312-6. doi: 10.1208/s12248-015-9777-x. Epub 2015 May 6.

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