Assessing biosimilarity and interchangeability of biosimilar products.
- Published in:
- Statistics in Medicine, 2013, v. 32, n. 3, p. 361, doi. 10.1002/sim.5577
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- Publication type:
- Article
Works matching IS 02776715 AND DT 2013 AND VI 32 AND IP 3
Results: 16
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Flexible bivariate phase II clinical trial design incorporating toxicity and response on different schedules.
- Published in:
- Statistics in Medicine, 2013, v. 32, n. 3, p. 470, doi. 10.1002/sim.5671
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- Article
3
Statistical methods for assessing interchangeability of biosimilars.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 442, doi. 10.1002/sim.5566
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- Article
4
Superchain procedures in clinical trials with multiple objectives.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 486, doi. 10.1002/sim.5537
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- Article
5
Comments on the FDA draft guidance on biosimilar products.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 364, doi. 10.1002/sim.5572
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- Publication type:
- Article
6
Application of the parallel line assay to assessment of biosimilar products based on binary endpoints Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 449, doi. 10.1002/sim.5565
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- Publication type:
- Article
7
On the interchangeability of biologic drug products.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 434, doi. 10.1002/sim.5569
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- Publication type:
- Article
8
Statistical assessment of biosimilarity based on relative distance between follow-on biologics.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 382, doi. 10.1002/sim.5582
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- Article
9
Scientific considerations for assessing biosimilar products.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 370, doi. 10.1002/sim.5571
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- Article
10
An adapted F-test for homogeneity of variability in follow-on biological products.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 415, doi. 10.1002/sim.5568
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- Publication type:
- Article
11
The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 406, doi. 10.1002/sim.5570
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- Article
12
Statistical considerations in biosimilar clinical efficacy trials with asymmetrical margins.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 393, doi. 10.1002/sim.5612
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- Article
13
Adaptive linear rank tests for eQTL studies.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 524, doi. 10.1002/sim.5593
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- Article
14
Comparability of critical quality attributes for establishing biosimilarity.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 462, doi. 10.1002/sim.5564
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- Publication type:
- Article
15
Dynamic semiparametric Bayesian models for genetic mapping of complex trait with irregular longitudinal data.
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- Statistics in Medicine, 2013, v. 32, n. 3, p. 509, doi. 10.1002/sim.5535
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- Publication type:
- Article
16
Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics.
- Published in:
- Statistics in Medicine, 2013, v. 32, n. 3, p. 424, doi. 10.1002/sim.5567
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- Publication type:
- Article