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Items: 1 to 20 of 105

1.

Consistency assessment with global and bridging development strategies in emerging markets.

Li G, Chen J, Quan H, Shentu Y.

Contemp Clin Trials. 2013 Nov;36(2):687-96. doi: 10.1016/j.cct.2013.05.006. Epub 2013 May 21.

PMID:
23702264
2.

New paradigm for drug developments--from emerging market statistical perspective.

Quan H, Chen X, Zhang J, Zhao PL.

Contemp Clin Trials. 2013 Nov;36(2):697-703. doi: 10.1016/j.cct.2013.06.009. Epub 2013 Jun 25.

PMID:
23810938
3.

Establishing consistency across all regions in a multi-regional clinical trial.

Tsou HH, James Hung HM, Chen YM, Huang WS, Chang WJ, Hsiao CF.

Pharm Stat. 2012 Jul-Aug;11(4):295-9. doi: 10.1002/pst.1512. Epub 2012 Apr 16.

PMID:
22504851
5.

Clinical trials in "emerging markets": regulatory considerations and other factors.

Singh R, Wang O.

Contemp Clin Trials. 2013 Nov;36(2):711-8. doi: 10.1016/j.cct.2013.09.006. Epub 2013 Sep 24.

PMID:
24070788
6.

[Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase].

Kock M, Thomsen MK.

Ugeskr Laeger. 2003 Apr 14;165(16):1649-52. Review. Danish.

PMID:
12756820
7.

Sample size determination for a specific region in a multiregional trial.

Ko FS, Tsou HH, Liu JP, Hsiao CF.

J Biopharm Stat. 2010 Jul;20(4):870-85. doi: 10.1080/10543401003618900.

PMID:
20496211
8.

Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance.

Quan H, Zhao PL, Zhang J, Roessner M, Aizawa K.

Pharm Stat. 2010 Apr-Jun;9(2):100-12. doi: 10.1002/pst.380.

PMID:
19499510
9.

A consistency approach to evaluation of bridging studies and multi-regional trials.

Tsou HH, Chien TY, Liu JP, Hsiao CF.

Stat Med. 2011 Jul 30;30(17):2171-86. doi: 10.1002/sim.4251. Epub 2011 May 17.

PMID:
21590701
10.

A predictive Bayesian approach to the design and analysis of bridging studies.

Gould AL, Jin T, Zhang LX, Wang WW.

J Biopharm Stat. 2012 Sep;22(5):916-34. doi: 10.1080/10543406.2012.701579. Review.

PMID:
22946940
11.

Reproducibility probability in clinical trials.

Shao J, Chow SC.

Stat Med. 2002 Jun 30;21(12):1727-42.

PMID:
12111908
12.

Graphical assessment of consistency in treatment effect among countries in multi-regional clinical trials.

Chen J, Zheng H, Quan H, Li G, Gallo P, Ouyang SP, Binkowitz B, Ting N, Tanaka Y, Luo X, Ibia E; Society for Clinical Trials (SCT) Multi-regional Clinical Trial (MRCT) Consistency Working Group.

Clin Trials. 2013;10(6):842-51. doi: 10.1177/1740774513500387. Epub 2013 Sep 6.

PMID:
24013404
13.

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.

Rezaie R, McGahan AM, Frew SE, Daar AS, Singer PA.

Health Res Policy Syst. 2012 Jun 6;10:18. doi: 10.1186/1478-4505-10-18.

14.

Policy developments in regulatory approval.

Temple R.

Stat Med. 2002 Oct 15;21(19):2939-48.

PMID:
12325110
15.

Challenges in the clinical development requirements for the marketing authorization of new medicines in southeast Asia.

Kudrin A.

J Clin Pharmacol. 2009 Mar;49(3):268-80. doi: 10.1177/0091270008329557. Epub 2009 Jan 22.

PMID:
19168433
16.

Managing the health care market in developing countries: prospects and problems.

Broomberg J.

Health Policy Plan. 1994 Sep;9(3):237-51. Review.

17.

Efficient clinical trials in Japan: Bridging studies versus participation in global clinical trials.

Shirotani M, Suwa T, Kurokawa T, Chiba K.

J Clin Pharmacol. 2014 Apr;54(4):438-45. doi: 10.1002/jcph.216. Epub 2013 Nov 19.

PMID:
24165947
18.

Global randomized trials: the promise of India and China.

Perkovic V, Patil V, Wei L, Lv J, Petersen M, Patel A.

J Bone Joint Surg Am. 2012 Jul 18;94 Suppl 1:92-6. doi: 10.2106/JBJS.L.00274.

PMID:
22810456
19.

Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

Alvarenga LS, Martins EN.

Rev Assoc Med Bras. 2010 Jul-Aug;56(4):428-33.

20.

Lack of compliance of European Public Assessment Reports to guidelines for paediatric drug development before the introduction of paediatric investigation plans.

Piana C, Kliphuis E, Della Pasqua O.

Clin Trials. 2013 Apr;10(2):269-79. doi: 10.1177/1740774512470220. Epub 2013 Jan 18.

PMID:
23335676
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