Analytical Comparability and Similarity
Author:
Publisher
Springer International Publishing
Link
http://link.springer.com/content/pdf/10.1007/978-3-319-50186-4_9
Reference26 articles.
1. Burdick RK, Sidor L (2013) Establishment of an equivalence acceptance criterion for accelerated stability studies. J Biopharm Stat 23:730–743
2. Burdick RK, Pferdeort V, Sidor L, Tholudur A (2011) A graphical representation for a statistical test of average equivalence and variance comparison with process data. Qual Reliab Eng Int 27(6):771–780
3. Burdick R, Coffey T, Gutka H, Gratzl G, Conlon H, Huang C-T, Boyne M, Kuehne H (2016) Statistical approaches to assess biosimilarity from analytical data. AAPS J. doi: 10.1208/s12248-016-9968-0
4. Chatfield MJ, Borman PJ, Damjanov I (2011) Evaluating change during pharmaceutical product development and manufacture—comparability and equivalence. Qual Reliab Eng Int 27:629–640
5. Chow S-C (2014) On assessment of analytical similarity in biosimilar studies. Drug Des 3:119. doi: 10.4172/2169-0138.1000e124 , Accessed 28 Nov 2015
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