References
- 1992 . “ Informal Communication by the Division of Bioequivalence ” . In Guidance on Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design Rockville, MD : Food and Drug Administration (FDA), Office of Generic Drugs .
- " Commission of the European Communities ." Guidance: Investigation of Bioavailability and Bioequivalence , Committee for Proprietary Medical Products (CPMP) 1992
- 1991 . Drugs Directorate Policy: CI Standard for Comparative Bioavailability Ottawa, , Canada : Canadian Health Protection Branch (HPB) .
- Chow , S C and Liu , J P . 1997 . Meta-analysis for Bioequivalence Review . J. Biopharm. Stat. , 7 : 97 – 111 .
- Chow , S C and Shao , J . 1999 . Bioequivalence Review for Drug Interchangeability . J. Biopharm. Stat. , 9 : 485 – 497 .
- Diletti , E , Hauschke , D and Steinijans , V W . 1991 . Sample Size Determination for Bioequivalence Assessment by Means of Confidence Intervals . Int. J. Clin. Pharmacol. Ther. Toxicol. , 29 : 1 – 8 .
- Wang , Y and Zhou , S . 1999 . Pilot Trial for the Assessment of Relative Bioavailability in Generic Drug Product Development: Statistical Power . J. Biopharm. Stat. , 9 : 179 – 187 .
- Wang , Y . 1999 . Use of Jackknife Influence Profiles in Bioequivalence Evaluations . Pharm. Sci. Technol. Today , 2 : 152 – 159 .
- Wang , Y , Eradiri , O , Odidi , I , Geng , W , Odidi , A and Muhuri , G . 1998 . Scale Effect in Bioequivalence Evaluations . Int. J. Clin. Pharmacol. Ther. , 36 : 534 – 539 .
- Liu , J P and Weng , C S . 1997 . Bias of Two One-Sided Tests Procedures in Assessment of Bioequivaxnlence . Stat. Med. , 14 : 853 – 861 .