Biopharmaceuticals

Autor: Gils, Ann, Bertolotto, Antonio, Mulleman, Denis, Bejan-Angoulvant, Theodora, Declerck, Paul

Publikováno v: Therapeutic Drug Monitoring
Therapeutic Drug Monitoring, Lippincott, Williams & Wilkins, 2017, 39 (4), pp.308-315. ⟨10.1097/FTD.0000000000000385⟩

International audience; Biopharmaceuticals are primarily therapeutic proteins developed to perform specific functions by acting on the disease pathophysiology. Compared with low-molecular chemically synthesized drugs, production of biopharmaceuticals

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=od______2592::f31e265c7cf64803dfeba760f5957a8a
https://hal-univ-tours.archives-ouvertes.fr/hal-01980742

Extension of the SAEM algorithm for nonlinear mixed models with 2 levels of random effects

Autor: Xavière Panhard, Adeline Samson

Publikováno v: Biostatistics
Biostatistics, 2009, 10 (1), pp.121-35. ⟨10.1093/biostatistics/kxn020⟩
Biostatistics, Oxford University Press (OUP), 2009, 10 (1), pp.121-35. 〈10.1093/biostatistics/kxn020〉
Biostatistics, Oxford University Press (OUP), 2009, 10 (1), pp.121-35. ⟨10.1093/biostatistics/kxn020⟩

International audience; This article focuses on parameter estimation of multilevel nonlinear mixed-effects models (MNLMEMs). These models are used to analyze data presenting multiple hierarchical levels of grouping (cluster data, clinical trials with

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::aa9be0c749038a51c084b80c9d54f716
https://doi.org/10.1093/biostatistics/kxn020

A retrospective evaluation of the efficacy of intravenous bumetanide and comparison of potency with furosemide

Autor: Jean M. Nappi

Publikováno v: Pharmacy Practice
Pharmacy Practice (Granada) v.11 n.1 2013
SciELO España. Revistas Científicas Españolas de Ciencias de la Salud
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*Background: The potency of intravenous bumetanide to furosemide using a ratio of 1:40 has been suggested; however, there are little data supporting this ratio. Recent drug shortages required the use of bumetanide in a large patient population, enabl

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1144f05496e42c8b199da9ed809ec65a
https://pubmed.ncbi.nlm.nih.gov/24155849

Generics and substitution modalities: proposed methods for the evaluation of equivalence, traceability and pharmacovigilance reporting

Autor: Véronique Lamarque, Louis Merle, Jean Paul Demarez, Haleh Bagheri, Arnaud Biraben, Jean-Paul Fagot, Jean-Dominique Hamel, Carmen Kreft-Jaïs, Françoise Haramburu, Marie-Laure Laroche, Hervé Le Louet, Claire Martray, Jacques Mascaro, Christian Pisano, Myriam Rosilio, Franck Rouby, Alain Saint-Pierre, Éric Singlas

Publikováno v: Thérapie
Thérapie, EDP Sciences, 2008, 63 (4), pp.301-9. ⟨10.2515/therapie:2008047⟩

ERMA; International audience; The use of generics results in savings for the budget of the health insurance, and no player of health could question seriously the principle. The generic drug of a reference medicinal product defines itself as a drug ha

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::53e35678bc10d94b1dac8b10c545cd0a
https://pubmed.ncbi.nlm.nih.gov/18937910

Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance

Autor: Renaud Verdon, Véronique Massari, Jean-Jacques Parienti

Publikováno v: BMC Medical Research Methodology
BMC Medical Research Methodology, 2006, 6, pp.46. ⟨10.1186/1471-2288-6-46⟩
BMC Medical Research Methodology, BioMed Central, 2006, 6, pp.46. ⟨10.1186/1471-2288-6-46⟩
BMC Medical Research Methodology, Vol 6, Iss 1, p 46 (2006)

Background The interpretation of the results of active-control trials regarding the efficacy and safety of a new drug is important for drug registration and following clinical use. It has been suggested that non-inferiority and equivalence studies ar

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4360a3af3077a2854f54c7a7915bdd44
http://europepmc.org/articles/PMC1592102