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Table 1 Current set of major guidelines for bioequivalence studies in Japan (published from MHLW)

From: Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

Guideline for Bioequivalence Studies of Generic Products
Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms
Guideline for Bioequivalence Studies of Generic Products for Different Strengths of Oral Solid Dosage Forms
Guideline for bioequivalence studies for different oral solid dosage forms
Bioequivalence Studies of Generic Products for Ethical Combination Drug Products
Bioequivalence Studies for Different Strengths of Ethical Combination Drug Products and Formulation Changes of Ethical Combination Drug Products
Guidance for Bioequivalence Studies of Generic Products for Topical Use