Bioequivalence (BE)

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

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

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