Statistical considerations in biosimilar assessment using biosimilarity index

Journal of Bioequivalence and Bioavailability

Volumn 5, Issue 5, 2013, Pages

  Zhang, Aijing ^a   Tzeng, Jung Ying ^a   Chow, Shein Chung ^b  

^a NORTH CAROLINA STATE UNIVERSITY   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Biosimilarity index; Degree of similarity; Highly similar; Reproducibility probability

Indexed keywords

ARTICLE; BIOSIMILARITY INDEX; CONTROLLED STUDY; PROBABILITY; QUANTITATIVE STUDY; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; VARIANCE;

EID: 84885047942     PISSN: None     EISSN: 09750851     Source Type: Journal    
DOI: 10.4172/jbb.1000160     Document Type: Article

References (8)

1. (2012) Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Center for Drug Evaluation and Research, the US Food and Drug Administration.
2. Chow SC, Wang J, Endrenyi L, Lachenbruch PA (2013) Scientific considerations for assessing biosimilar products. Stat Med 32: 370-381.
3. Shao J, Chow SC (2002) Reproducibility probability in clinical trials. Stat Med 21: 1727-1742.
4. Chow SC, Yang LY, Starr A, Chiu ST (2013) Statistical methods for assessing interchangeability of biosimilars. Stat Med 32: 442-448.
5. Zhang AJ, Tzeng JY, Chow SC (2013) Establishment of reference standards in biosimilar studies.
6. Kang SH, Chow SC (2013) Statistical assessment of biosimilarity based on relative distance between follow-on biologics. Stat Med 32: 382-392.
7. Chow SC, Hsieh TC, Chi E, Yang J (2010) A comparison of moment-based and probability-based criteria for assessment of follow-on biologics. J Biopharm Stat 20: 31-45.
8. Hsieh TC, Chow SC, Liu JP, Hsiao CF, Chi E (2010) Statistical test for evaluation of biosimilarity in variability of follow-on biologics. J Biopharm Stat 20: 75-89.