Scientific considerations for assessing biosimilar products.
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Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseasesSample size determination for individual bioequivalence inferenceAvoiding ambiguity with the Type I error rate in noninferiority trials.Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.Estimation and approximation approaches for biosimilar index based on reproducibility probability.A Calibrated Power Prior Approach to Borrow Information from Historical Data with Application to Biosimilar Clinical Trials.Statistical assessment of biosimilarity based on the relative distance between follow-on biologics for binary endpoints.
P2860
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P2860
Scientific considerations for assessing biosimilar products.
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2012 nî lūn-bûn
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2012年の論文
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Scientific considerations for assessing biosimilar products.
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Scientific considerations for assessing biosimilar products.
@nl
type
label
Scientific considerations for assessing biosimilar products.
@en
Scientific considerations for assessing biosimilar products.
@nl
prefLabel
Scientific considerations for assessing biosimilar products.
@en
Scientific considerations for assessing biosimilar products.
@nl
P2093
P2860
P356
P1476
Scientific considerations for assessing biosimilar products.
@en
P2093
Laszlo Endrenyi
Peter A Lachenbruch
Shein-Chung Chow
P2860
P304
P356
10.1002/SIM.5571
P407
P577
2012-08-30T00:00:00Z