Guidelines issued by Ministry of Health, Labour and Welfare, Govermment of Japan

Source: Division of Drug, NIHS(National Institute of Health Science)
https://www.nihs.go.jp/drug/index-E.html

• 1. Guideline and QA for BE Studies of Generic Products(2012)
  • Guideline
  • Q&A
• 2. Guideline and QA for BE Studies of Generic Products for Different Strengths of Oral Solid Dosage Forms(2012)
  • Guideline
  • Q&A
• 3. Guideline and QA for BE Studies for Formulation Change of Oral Solid Dosage Forms(2012)
  • Guideline
  • Q&A
• 4. Guideline and QA for BE Studies for Different Oral Solid Dosage Forms(2012)
  • Guideline
  • Q&A
• 5. Q＆A BE Studies for Generic Products for Ethical Combination Drug Products(2012)
  • Q&A
• 6. Q＆A BE Studies for Different Strengths of Ethical Combination Drug Products and Formulation Changes of Ethical Combination Drug Products(2012)
  • Q&A
• 7. Guidelines for the Design and Evaluation of Oral Prolonged Dosage Forms(1988)
  • Guideline