Statistical methods for assessing interchangeability of biosimilars

Author:

Chow Shein-Chung1,Yang Lan-Yan,Starr Aijing2,Chiu Shih-Ting3

Affiliation:

1. Biostatistics and Bioinformatics; Duke University School of Medicine; Durham; NC; U.S.A.

2. Department of Statistics; North Carolina State University; Raleigh; NC; U.S.A.

3. Division of Biometry, Department of Agronomy; National Taiwan University; Taipei; Taiwan

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference17 articles.

1. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability;Schuirmann;Journal of Pharmacokinetics and Biopharmaceutics,1987

2. EMEA Note for Guidance on the Investigation of Bioavailability and Bioequivalence London, United Kingdom 2001

3. FDA Guidance on Statistical Approaches to Establishing Bioequivalence Rockville, Maryland, USA 2001

4. FDA Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products - General Considerations Rockville, Maryland, USA 2003

5. FDA Guidance on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action Rockville, Maryland, USA 2003

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