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Results 1 - 10 of 14  for Great Falls College MSU

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An adapted F-test for homogeneity of variability in follow-on biological products.

Yang, Jun ; Zhang, Nan ; Chow, Shein-Chung ; Chi, Eric Yang, Jun (correspondence author) ; Yang, Jun (record owner)

Statistics in medicine, February 10, 2013, Vol.32(3), pp.415-423 [Peer Reviewed Journal]

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Scientific considerations for assessing biosimilar products.

Chow, Shein-Chung ; Wang, Jun ; Endrenyi, Laszlo ; Lachenbruch, Peter A Chow, Shein-Chung (correspondence author) ; Chow, Shein-Chung (record owner)

Statistics in medicine, February 10, 2013, Vol.32(3), pp.370-381 [Peer Reviewed Journal]

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The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics.

Hsieh, Tsung-Cheng ; Chow, Shein-Chung ; Yang, Lan-Yan ; Chi, Eric Hsieh, Tsung-Cheng (correspondence author) ; Hsieh, Tsung-Cheng (record owner)

Statistics in medicine, February 10, 2013, Vol.32(3), pp.406-414 [Peer Reviewed Journal]

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Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics.

Zhang, Nan ; Yang, Jun ; Chow, Shein-Chung ; Endrenyi, Laszlo ; Chi, Eric Zhang, Nan (correspondence author) ; Zhang, Nan (record owner)

Statistics in medicine, February 10, 2013, Vol.32(3), pp.424-433 [Peer Reviewed Journal]

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Comments on the FDA draft guidance on biosimilar products.

Chow, Shein-Chung ; Endrenyi, Laszlo ; Lachenbruch, Peter A Chow, Shein-Chung (correspondence author) ; Chow, Shein-Chung (record owner)

Statistics in medicine, February 10, 2013, Vol.32(3), pp.364-369 [Peer Reviewed Journal]

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Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.

Lin, Jr-Rung ; Chow, Shein-Chung ; Chang, Chih-Hsi ; Lin, Ya-Ching ; Liu, Jen-Pei Lin, Jr-Rung (correspondence author) ; Lin, Jr-Rung (record owner)

Statistics in medicine, February 10, 2013, Vol.32(3), pp.449-461 [Peer Reviewed Journal]

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Statistical assessment of biosimilarity based on relative distance between follow-on biologics.

Kang, Seung-Ho ; Chow, Shein-Chung Kang, Seung-Ho (correspondence author) ; Kang, Seung-Ho (record owner)

Statistics in medicine, February 10, 2013, Vol.32(3), pp.382-392 [Peer Reviewed Journal]

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Biosimilar drug product development
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Book
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Biosimilar drug product development

Endrenyi, Laszlo ; Declerck, Dr. Paul ; Chow, Shein-Chung; Endrenyi, Laszlo ; Declerck, Paul ; Chow, Shein-Chung 2016

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An adjusted two one-sided t-test for the assessment of bioequivalence with multiple doses.

Wang, W ; Hsuan, F ; Chow, S C Wang, W (correspondence author) ; Wang, W (record owner)

Journal of biopharmaceutical statistics, March 1997, Vol.7(1), pp.157-170 [Peer Reviewed Journal]

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On non-inferiority margin and statistical tests in active control trials.

Chow, Shein-Chung ; Shao, Jun Chow, Shein-Chung (correspondence author) ; Chow, Shein-Chung (record owner)

Statistics in medicine, April 15, 2006, Vol.25(7), pp.1101-1113 [Peer Reviewed Journal]

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