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The New England Journal of Medicine, ISSN 0028-4793, 02/2014, Volume 370, Issue 9, pp. 818 - 828
Journal Article
The New England Journal of Medicine, ISSN 0028-4793, 02/2014, Volume 370, Issue 9, pp. 829 - 837
Journal Article
PLoS ONE, ISSN 1932-6203, 01/2019, Volume 14, Issue 1, p. e0210953
This study was inspired by the need to estimate pointwise confidence intervals (CIs) for a nonlinear dose-response model from a dose-finding clinical trial.... 
MULTIDISCIPLINARY SCIENCES | Confidence intervals | Dose-response relationship (Biochemistry) | Clinical trials | Usage | Analysis | Performance evaluation | Economic models | Computer simulation | Optimization | Studies | Algorithms | Computation | Mathematical models | Nonlinear response | Drug dosages | Methods
Journal Article
Journal of the Royal Statistical Society: Series C (Applied Statistics), ISSN 0035-9254, 11/2017, Volume 66, Issue 5, pp. 979 - 996
Summary A biosimilar product refers to a follow‐on biologic that is intended to be approved for marketing on the basis of biosimilarity to an existing patented... 
Calibrated power prior | Historical data | Biosimilarity index | Bayesian adaptive design | Follow‐up biologics | Borrowed information | Biosimilar | Follow-up biologics | VARIABILITY | MODELS | PRODUCTS | STATISTICS & PROBABILITY | FOLLOW-ON BIOLOGICS | Clinical trials | Biological products | Medical research | Arthritis | Similarity | Bayesian analysis | Biosimilars | Borrow information
Journal Article
PLoS ONE, ISSN 1932-6203, 12/2018, Volume 13, Issue 12, p. e0208354
Analytical similarity assessment of critical quality attributes (CQAs) serves as a foundation for the development of biosimilar products and facilitates an... 
SAMPLE-SIZE | EQUIVALENCE ASSESSMENT | MULTIDISCIPLINARY SCIENCES | Biosimilar pharmaceuticals | Usage | Mann-Whitney U test | Mathematical statistics | Quality management | Evaluation | Biological products | Statistical analysis | Similarity | Computer simulation | Statistical methods | Bioavailability | Statistics | Clinical outcomes | Studies | Equivalence | Quality | Quality assessment | Methods
Journal Article
Gut, ISSN 0017-5749, 12/2018, Volume 67, Issue 12, pp. 2156 - 2168
Journal Article
Journal of Biopharmaceutical Statistics, ISSN 1054-3406, 2019, pp. 1 - 13
The effect of reference treatment over placebo, known as M1, is essential in the development of non-inferiority margin. We proposed a M1 adjustment approach to... 
selection bias | non-inferiority margin | Effect size | simulation study | power analysis
Journal Article
PLoS ONE, ISSN 1932-6203, 12/2013, Volume 8, Issue 12, p. e81045
Propensity score matching is a method to reduce bias in non-randomized and observational studies. Propensity score matching is mainly applied to two treatment... 
CAUSAL INFERENCE | BIAS | MULTIDISCIPLINARY SCIENCES | Models, Theoretical | Propensity Score | Models, Statistical | Monte Carlo Method | Humans | Monte Carlo method | Models | Calipers | Computer simulation | Bias | Mental health | Probability | Multivariate analysis | Matching | Studies | Algorithms | Simulation | Standard deviation | Product safety | Drug dosages
Journal Article
International Journal of Cancer, ISSN 0020-7136, 01/2017, Volume 140, Issue 2, pp. 390 - 399
Journal Article
Journal Article
Investigational New Drugs, ISSN 0167-6997, 06/2019, Volume 37, Issue 3, pp. 401 - 414
Background & Aims Sorafenib-related adverse events have been reported as clinical surrogates for treatment response in hepatocellular carcinoma (HCC); however,... 
Predictive value | Hepatocellular carcinoma | Adverse events | Sorafenib | Studies | Time dependence | Identification methods | Landmarks | Skin | Criteria | Multivariate analysis | Survival | Subgroups | Feet
Journal Article