Cargando…
Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
BACKGROUND: Health Canada’s Summary Basis of Decision (SBD) documents outline the clinical trial information that was considered in approving a new drug. We examined the ability of SBDs to inform clinician decision-making. We asked if SBDs answered three questions that clinicians might have prior to...
Autores principales: | Habibi, Roojin, Lexchin, Joel |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2014
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3961288/ https://www.ncbi.nlm.nih.gov/pubmed/24651766 http://dx.doi.org/10.1371/journal.pone.0092038 |
Ejemplares similares
-
A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study
por: Lexchin, Joel
Publicado: (2021) -
Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review
por: Spurling, Geoffrey K., et al.
Publicado: (2010) -
Information about confirmatory studies required for new drugs conditionally approved by Health Canada: A cross-sectional study
por: Lexchin, Joel
Publicado: (2022) -
Health Canada's Proposal to Accelerate New Drug Reviews
por: Lexchin, Joel
Publicado: (2020) -
Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study
por: Lexchin, Joel
Publicado: (2018)