PLACEBO FOR USE WITH BIOLOGIC

Title:

PLACEBO FOR USE WITH BIOLOGIC

Document Type and Number:

Japanese Patent JP2008120722

Kind Code:

A

Abstract:

To provide a placebo which is substantially identical with a biologic in appearance, is pharmaceutically safe, has no efficacy unlike a biologic, and is capable of being handled in the same manner as in an investigational new drug used in e.g., a double blind method.

The placebo for use with a biologic contains a substance having surface activity. Desirably, the placebo is one wherein the substance having surface activity is a surfactant.

Inventors:

OTANI KAZUHIRO
KIMURA KAZUYUKI
KUWABARA EIKI

Application Number:

JP2006305703A

Publication Date:

May 29, 2008

Filing Date:

November 10, 2006

Export Citation:

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Assignee:

BENESIS CORP

International Classes:

A61K49/00; A61K47/36; A61K47/46

Domestic Patent References:

JP2001525816A	2001-12-11
JPH08504755A	1996-05-21

Foreign References:

WO2005099776A2

2005-10-27

Other References:

JPN6012014590; ＭＯＲＥＬＡＮＤ，Ｌ．Ｗ．　ｅｔ　ａｌ: 'Ｔｒｅａｔｍｅｎｔ　ｏｆ　ｒｈｅｕｍａｔｏｉｄ　ａｒｔｈｒｉｔｉｓ　ｗｉｔｈ　ａ　ｒｅｃｏｍｂｉｎａｎｔ　ｈｕｍａｎ　ｔｕｍｏｒ　ｎｅｃｒｏｓｉｓ　ｆａｃｔｏｒ　ｒｅｃｅｐｔｏｒ　（ｐ７５）-Ｆｃ　ｆ' Ｎ　Ｅｎｇｌ　Ｊ　ＭｅｄＶｏｌ．３３７，　Ｎｏ．３, 1997, ｐ．１４１-７
JPN7012001007; ＰＭＤＡ: 審査報告書 , 20041105
JPN6012014595; 大杉義征ら: 'キャッスルマン病治療薬，遺伝子組換えヒト化抗ヒトインターロイキン-６受容体抗体（トシリズマブ）の薬理学的' 日本薬理学雑誌Ｖｏｌ．１２６，　Ｎｏ．６, 2005, ４１９-２５
JPN7012001008; 医薬食品局審査管理課: 審議結果報告書 , 20050228

Attorney, Agent or Firm:

Takashima Ichi

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