Title:
PRODUCT QUALITY CONTROL METHOD
Document Type and Number:
WIPO Patent Application WO/2013/008733
Kind Code:
A1
Abstract:
The purpose of the invention is to provide a real time release test that can constantly guarantee quality and a product quality testing method that uses said real time release test. The invention provides an in-process product and/or final product quality testing method that uses real time release testing and which comprises a process of assessing quality using a design space designed with only material properties as input variables. The invention provides a product quality testing method using real time release testing that does not depend on production parameters.
Inventors:
NAKAGAWA HIROSHI
KAMADA MAKOTO
MAEDA JIN
KAMADA MAKOTO
MAEDA JIN
Application Number:
PCT/JP2012/067287
Publication Date:
January 17, 2013
Filing Date:
July 06, 2012
Export Citation:
Assignee:
DAIICHI SANKYO CO LTD (JP)
NAKAGAWA HIROSHI
KAMADA MAKOTO
MAEDA JIN
NAKAGAWA HIROSHI
KAMADA MAKOTO
MAEDA JIN
International Classes:
A61J3/06; A61J3/07; G01N33/15
Domestic Patent References:
| WO2003000657A1 | 2003-01-03 | |||
| WO2003000680A1 | 2003-01-03 |
Other References:
"Seizai Kaihatsu ni Kansuru Guideline no Kaitei ni Tsuite", MINISTRY OF HEALTH, LABOUR AND WELFARE, 28 June 2010 (2010-06-28), XP008171914, Retrieved from the Internet [retrieved on 20120829]
"ICH Harmonised Tripartite Guideline, Pharmaceutical Development Q8 (R2", CURRENT STEP 4 VERSION, August 2009 (2009-08-01)
YUKIO HIYAMA: "Health and Labour Sciences Research Grants", RESEARCH ON THE RAPID AND EFFICIENT PROCESS CONSTRUCTION OF PHARMACEUTICAL MANUFACTURING OR DEVELOPMENT AND APPROVAL REVIEW, 2008 JOINT RESEARCH REPORT
YUKIO HIYAMA ET AL.: "MHLW Sponsored Science Research Study, Establishing Design Space in critical steps and Control Strategy", QUALITY OVERALL SUMMARY MOCK P2 (DESCRIPTION EXAMPLES, March 2009 (2009-03-01), pages 1 - 57
"Application Form for Sakura Tablet, Mock-Up for the Manufacture Method, Specifications, and Test Method Columns of Drug Product (Sample Description), Application Form for Sakura tablet V2 01 0900310", RESEARCH ON THE CONSTRUCTION OF STEADY AND EFFICIENT PROCESSES FOR THE MANUFACTURE, DEVELOPMENT, AND APPROVAL REVIEW OF DRUGS, pages 1 - 13
CHEM. PHARM. BULL., vol. 49, no. 11, 2001, pages 1412 - 1419
See also references of EP 2730269A4
"ICH Harmonised Tripartite Guideline, Pharmaceutical Development Q8 (R2", CURRENT STEP 4 VERSION, August 2009 (2009-08-01)
YUKIO HIYAMA: "Health and Labour Sciences Research Grants", RESEARCH ON THE RAPID AND EFFICIENT PROCESS CONSTRUCTION OF PHARMACEUTICAL MANUFACTURING OR DEVELOPMENT AND APPROVAL REVIEW, 2008 JOINT RESEARCH REPORT
YUKIO HIYAMA ET AL.: "MHLW Sponsored Science Research Study, Establishing Design Space in critical steps and Control Strategy", QUALITY OVERALL SUMMARY MOCK P2 (DESCRIPTION EXAMPLES, March 2009 (2009-03-01), pages 1 - 57
"Application Form for Sakura Tablet, Mock-Up for the Manufacture Method, Specifications, and Test Method Columns of Drug Product (Sample Description), Application Form for Sakura tablet V2 01 0900310", RESEARCH ON THE CONSTRUCTION OF STEADY AND EFFICIENT PROCESSES FOR THE MANUFACTURE, DEVELOPMENT, AND APPROVAL REVIEW OF DRUGS, pages 1 - 13
CHEM. PHARM. BULL., vol. 49, no. 11, 2001, pages 1412 - 1419
See also references of EP 2730269A4
Attorney, Agent or Firm:
ISHIBASHI Koki et al. (JP)
Kimiki Ishibashi (JP)
Kimiki Ishibashi (JP)
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