154 captures

03 Jun 1997 - 05 Oct 2025

Apr	MAY	Jun
	15
2018	2019	2020

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About this capture

COLLECTED BY

Organization: Alexa Crawls

Starting in 1996, Alexa Internet has been donating their crawl data to the Internet Archive. Flowing in every day, these data are added to the Wayback Machine after an embargo period.

Collection: Alexa Crawls

Starting in 1996, Alexa Internet has been donating their crawl data to the Internet Archive. Flowing in every day, these data are added to the Wayback Machine after an embargo period.

TIMESTAMPS

Announcement

• Pharmaceutical Development and Quality Assurance

  Continuous Manufacturing

  Points to Consider Regarding Continuous Manufacturing (May. 2017) .
  ______(The English part begins from p.10. )

  State of Control in Continuous Pharmaceutical Manufacturing (May. 2018) . NEW!
  ______(The English part begins from p.7. )

  Sakura Bloom Tablets: Mock-up

  Sakura Bloom Tablets P2 Mock (Feb. 2015) .　

  Approval Application Form Mock-up (Feb. 2017) . NEW!
  

  -------Explanation & Comments

  Sakura Tablets: Mock-up

  Response to the feedback on Mock P2 with Enhanced Approach(2010)

  ------English Mock QOS P2 Revised version(2010)------

  ------English Mock Application Form(2010)------
  

  Pharmaceutical Development P2 with Enhanced Approach(2008)

  ------Mock P2 English(FileC)(2008)------

  Draft GMP Guidelines For Comments (2004)

• Bioequivalence

  Guideline for Bioequivalence Studies of Generic Products (2012/02/29) Updated

         GL (pdf file), Q&A (pdf file)

  Guideline for Bioequivalence Studies of Generic Products for Different Strengths of Oral Solid Dosage Forms (2012/02/29) Updated

         GL (pdf file), Q&A (pdf file) 　　

  Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms (2012/02/29) Updated 　　

         GL (pdf file), Q&A (pdf file) 　

  Guideline for Bioequivalence Studies for Different Oral Solid Dosage Forms (2012/02/29) Updated 　　

         GL (pdf file), Q&A (pdf file)

  Bioequivalence Studies of Generic Products for Ethical Combination Drug Products (2012/02/29) 　　

         Q&A (pdf file) 　

  Bioequivalence Studies for Different Strengths of Ethical Combination Drug Products and Formulation Changes of Ethical Combination Drug Products (2012/02/29) 　　

         Q&A (pdf file)
  

  Guidelines for the Design and Evaluation of Oral Prolonged Release Dosage Forms (1988/03/11) 　　

         GL (pdf file)

  Old Guideline

• Nanomedicines

  Guideline for the Development of Liposome Drug Products NEW!

        [March 28, 2016, PSEHB/ELD Notification No. 0328-19, English translation]

  Reflection Paper on Nucleic Acids (siRNA)-Loaded Nanotechnology-Based Drug Products NEW!

        [March 28, 2016, PSEHB/ELD Administrative Notice, English translation]

  Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products

        [January 10, 2014, PFSB/ELS Notification No.0110-1]

              MHLW site for public consultation (only in Japanese)

              EMA site for public consultation

• Bioanalytical Method Validation

  Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development
  （Japanese／Q&A／English）

  Guideline on Bioanalytical Method Validation in Pharmaceutical Development (25 July 2013, MHLW, Japan)
  （Japanese／Q&A／English）

• Others

  Bioanalytical Method Validation and related areas.

  Validation of Analytical Procedures: Methodology (1996) Step 4, Consensus Guideline (obtained from EMEA)

  Guidelines for the Design and Evaluation of Oral Prolonged Release Dosage Forms (1988) (pdf file)

  Japanease Orange Book English Version

  NIHS Nanomedicine regulatory science research

To NIHS Home

Last edition: May. 29, 2018