1. Guideline for Bioequivalence Studies of Generic Products. Japan: December 22, 1997.
2. Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms. Japan: February 14, 2000.
3. Guideline for Bioequivalence Studies for Different Strengths of Oral Dosage Forms. Japan: February 14, 2000.
4. Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.
5. Modified-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.