A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A-Reference-Cited by-同舟云学术

A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A

Published:2017-12-06 Issue:9 Volume:57 Page:1123-1134
ISSN:0312-5963
Container-title:Clinical Pharmacokinetics
language:en
Short-container-title:Clin Pharmacokinet

Author:

Yoneyama Koichiro^ORCID,Schmitt Christophe^ORCID,Kotani Naoki,Levy Gallia G.,Kasai Ryu^ORCID,Iida Satofumi,Shima Midori,Kawanishi Takehiko

Funder

Chugai Pharmaceutical Co., Ltd.

F. Hoffmann-La Roche Ltd.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/article/10.1007/s40262-017-0616-3/fulltext.html

Reference49 articles.

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2. Geraghty S, Dunkley T, Harrington C, Lindvall K, Maahs J, Sek J. Practice patterns in haemophilia A therapy—global progress towards optimal care. Haemophilia. 2006;12:75–81.

3. Blanchette VS, Key NS, Ljung LR, et al. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014;12:1935–9.

4. Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19:e1–47.

5. Collins PW, Fischer K, Morfini M, et al. Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia. Haemophilia. 2011;17:2–10.

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