Different truncation methods of AUC between Japan and the EU for bioequivalence assessment: Influence on the regulatory judgment

Drug Metabolism and Pharmacokinetics

Volumn 27, Issue 6, 2012, Pages 658-662

  Oishi, Masayo ^a   Chiba, Koji ^a   Fukushima, Takashi ^a   Tomono, Yoshiro ^a   Suwa, Toshio ^a  

^a KEIO UNIVERSITY   (Japan)

Author keywords

AUC; Bioequivalence; Clinical pharmacokinetics; Drug development; Regulatory science; Sustained release formulation

Indexed keywords

GENERIC DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG INFORMATION; DRUG PACKAGING; DRUG SOLUBILITY; EUROPEAN UNION; INTERNATIONAL COOPERATION; JAPAN; LIMIT OF QUANTITATION; MAXIMUM PLASMA CONCENTRATION; MEASUREMENT ACCURACY; NOTE; PLASMA CONCENTRATION-TIME CURVE; PRACTICE GUIDELINE; SIMULATION; SUSTAINED RELEASE FORMULATION; VALIDITY;

EID: 84871673850     PISSN: 13474367     EISSN: 18800920     Source Type: Journal    
DOI: 10.2133/dmpk.DMPK-12-RG-033     Document Type: Article

References (8)

1. Ministry of Health, Labour and Welfare: Guideline for Bioequivalence Studies of Generic Products, 2011.
2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, CDER. Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products-General considerations, 2003.
3. European Medicines Agency: Guideline on the investigation of bioequivalence, 2010.
4. http://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html (2011).
5. Japanese package insert (approval number: 22000AMX02222000) (2009).
6. Japanese package insert (approval number: 21900AMX01126000) (2010).
7. Diletti, E., Hauschke, D. and Steinijans, V. W.: Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol., 29: 1-8 (1991).
8. Chen, M. L., Davit, B., Lionberger, R., Wahba, Z., Ahn, H. Y. and Yu, L. X.: Using partial area for evaluation of bioavailability and bioequivalence. Pharm. Res., 28: 1939-1947 (2011).