Results 111 to 120 of about 27,419 (207)

Beyond the label: ethical and clinical implications of off-label drug use in pediatric emergency care. [PDF]

Ital J Pediatr
Colombo M, Plebani A, Agosti M.
europepmc   +1 more source

Postmarketing analysis of sotatercept: identifying serious unlabelled events. [PDF]

Open Heart
Cao Z, Xiao Q, Li X, Zhang H, Zhang M.
europepmc   +1 more source

Effect of Safety Issues with HIV Drugs on the Approval Process of Other Drugs in the Same Class An Analysis of European Public Assessment Reports:an analysis of European public assessment reports

, 2011
Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required >= 1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for ...
de Graeff, Pieter A., Arnardottir, Arna H., Mol, Peter G. M.; id_orcid, Haaijer-Ruskamp, Flora M., Straus, Sabine M. J.   +4 more
core  

Postmarketing Research for Opioid Abuse-Deterrent Formulations: A Narrative Review. [PDF]

J Pain Res
Webster L, Gudin J, Green JL, Argoff CE.
europepmc   +1 more source

Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European public assessment reports

, 2011
Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required >/=1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety
Mol, P.G., Arnardottir, A.H., Haaijer-Ruskamp, F.M., de Graeff, P.A., Straus, S.M.   +4 more
core  

Postmarketing safety surveillance for GSK's AS01_E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study. [PDF]

BMJ Open
Adimadhyam S, Luyts D, Oraichi D, Deraedt Q, Pircon JY, Bilker WB, Agan AA, Rajbhandari R, Carbonari DM, Djibo DA, Wang X, Nolan MB, DeVries A, Selvan M, Ma Q, Wentz AE, Daniels K, Platt R, Lo Re V, Cocoros NM.   +19 more
europepmc   +1 more source

From a pyramid to an amphitheatre (triangle to circle): embracing the totality of evidence for the postmarketing evaluation of the safety of therapeutic interventions. [PDF]

BMJ Open
Shakir S, Lane S.
europepmc   +1 more source

Minimal dataset for post‐registration surveillance of new drugs in hemophilia: communication from the SSC of the ISTH

Journal of Thrombosis and Haemostasis, 2017
F. Peyvandi, M. Makris, Peter Collins, D. Lillicrap, S. Pipe, A. Iorio, F. Rosendaal   +6 more
semanticscholar   +1 more source

Safety Evaluation of Omniscan: An Observational Postmarketing Surveillance. [PDF]

Cureus
Mahajan H, Batta NS, Vaze P, Shad PS, Mahajan K, Hibberd MG, Roessink B, Dunham DM, Sahni J, Pandey R.   +9 more
europepmc   +1 more source

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler

, 1999
Bamber Mg
semanticscholar   +1 more source