Zobrazeno 1 - 5
of 5
pro vyhledávání: '"Maylis Coste"'
Publikováno v:
Journal of Biopharmaceutical Statistics. 15:869-882
Recently, two CPMP Points to Consider, one on adjustment for baseline covariates and the other on multiplicity issues in clinical trials, have included recommendations on the use of subgroup analysis for regulatory purposes. However, despite their re
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1bf2854fa4dd3ac92029c476f258aadf
https://doi.org/10.1081/bip-200067988
https://doi.org/10.1081/bip-200067988
Autor:
Philippe Truffinet, Régis Bordet, Joël Ménard, Serge Bakchine, Luc Buée, Soraya Cherchali, Maylis Coste, Bruno Dubois, Françoise Duveau, Jean-Marie Goehrs, Sylvia Goni, Philippe Gustovic, Catherine Lassale, Jean-Marc Orgogozo, Florence Pasquier, Odile Regnier, Franck Semah, Jacques Touchon, Marc Verny, Mohammed Zaïm
Publikováno v:
Therapie. 64(3)
The roundtable 1 “Relevance of the evaluation criteria used in clinical trials for Alzheimer’s disease” made reference to the guideline published by the EMEA (European Medicines Agency) in July 2008 on the development of new treatments for Alzh
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1fe68bee52a44c3036ebb08503f40271
https://pubmed.ncbi.nlm.nih.gov/19671425
https://pubmed.ncbi.nlm.nih.gov/19671425
Publikováno v:
Statistics in Medicine
Statistics in Medicine, Wiley-Blackwell, 2007, 26 (27), pp.4914-4924. ⟨10.1002/sim.2958⟩
Statistics in Medicine, Wiley-Blackwell, 2007, 26 (27), pp.4914-4924. ⟨10.1002/sim.2958⟩
International audience; The most common Bayesian methods for sample size determination (SSD) are reviewed in the non-sequential context of a confirmatory phase III trial in drug development. After recalling the regulatory viewpoint on SSD, we discuss
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::115792f7738f97246d02392a2eeed44d
https://hal.archives-ouvertes.fr/hal-00440391
https://hal.archives-ouvertes.fr/hal-00440391
Publikováno v:
Pharmacoepidemiology and Drug Safety
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::066ae3b30f6948d759c68d35b09a1250
https://doi.org/10.1002/pds.3283
https://doi.org/10.1002/pds.3283
Publikováno v:
Cancer. 78(9)
To optimize fotemustine chemotherapy, the authors considered how to combine independent Phase II trials to predict the risk of first occurrence of severe toxicity as a function of initial patient characteristics.Clinical data from six Phase II trials
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9bb9c130a9a235d7894f33f2e1ef882e
https://pubmed.ncbi.nlm.nih.gov/8909320
https://pubmed.ncbi.nlm.nih.gov/8909320