Statistical considerations for establishing bioequivalence

Generic Drug Product Development: Solid Oral Dosage Forms

Volumn , Issue , 2014, Pages 257-279

  Bolton, Sanford ^a  

^a UNIVERSITY OF ARIZONA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 70449484741     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (9)

1. Guidance for Industry, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products, General Considerations. FDA, CDER, October, 2000.
2. Bolton S. Pharmaceutical Statistics. 3rd ed. NewYork, NY: Marcel Dekker, 1997.
3. Statistical Approaches to Establishing Bioequivalence. US Department of Health and Human Services FDA CDER, January 2001.
4. Haynes JD. J Pharm Sci 1981; 70:673.
5. Schuirmann DJ, Pharmacokinet J. Biopharm 1987; 15:656-680.
6. Dilletti E, Hauschke D, Steinjens VW. Int J Clin Pharm Toxical 1991; 29:1.
7. The SAS System for Windows, Release 6.12, Cary, NC, 27513.
8. Hyslop T, Hsuan F, Hesney M. Stat Med 2000; 19:2885-2897.
9. Eckbohm, Melander H. Biometrics 1989; 45:1249-1254.