Monthly buprenorphine depot injection (SUBLOCADE®) for opioid use disorder during pregnancy
The American Journal on Addictions, EarlyView.Abstract Background and Objectives Untreated opioid use disorder (OUD) in pregnancy is associated with adverse obstetrical outcomes, maternal morbidity, and maternal mortality. This article will inform clinicians about the use of monthly extended‐release buprenorphine (BUP‐XR, SUBLOCADE®) to treat OUD during pregnancy and postpartum.
Melinda Ramage +3 more
wiley +1 more source
Regulating risks in pharmaceutical law : the need of an optimal interplay between products safety and products liability [PDF]
, 2011 Published online: 7 June 2011The aim of this paper is to call for the need of a theoretical model of pharmaceutical products safety in which the two systems of regulation and liability operate complementarily. The question is why two legal tools that are
RIZZI, Marco
core
Drug therapeutic failures as a cause of admission to an intensive care unit at a university hospital
Journal of Research in Pharmacy Practice, 2019 Objective: Drug therapeutic failures (TFs) are included in pharmacovigilance reporting, as some authors consider them a type of adverse drug reaction.
Jair Antonio Ruiz-Garzon +2 more
doaj +1 more source
Headache: The Journal of Head and Face Pain, EarlyView.Abstract Objectives/Background This study was undertaken to evaluate the postmarketing safety of monoclonal antibodies (mAbs) targeting the calcitonin gene‐related peptide pathway used for migraine prophylaxis through pharmacovigilance data analysis by examining suspected adverse events reported in Europe.
Victoria Nikitina +3 more
wiley +1 more source
Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis [PDF]
, 2015 BackgroundESPRIT is an ongoing, 10-year, observational registry, evaluating long-term safety and effectiveness of adalimumab treatment in routine clinical practice for patients with moderate to severe, chronic plaque psoriasis.ObjectivesInitial 5-year ...
Bereswill, Mareike +7 more
core +1 more source
Nelarabine Associated Myotoxicity and Rhabdomyolysis
Case Reports in Hematology, 2015 Nelarabine (ara-G; Arranon; compound 506U78) is an antineoplastic purine analog used for the treatment of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).
Mahnur Haider +2 more
doaj +1 more source
What Affects the Quality of Pharmacovigilance? Insights From Qualitative Comparative Analysis
Pharmacology Research &Perspectives, Volume 13, Issue 3, June 2025.ABSTRACT Pharmacovigilance plays a significant role in guaranteeing the safety of medications for patients. Over the last three decades, China has significantly advanced its pharmacovigilance practices, yet the factors that drive the quality of pharmacovigilance remain unclear.
Yadong Wang +6 more
wiley +1 more source
Indian clinical experience on an innovative product in the management of polycystic ovary syndrome
, 2020 Even today, polycystic ovary syndrome (PCOS) and its management remains a challenge. The entry of innovative products in the clinical armamentarium for PCOS management is welcome and needs to be investigated for their efficacy and safety in Indian women ...
B. Gawade, R. Hegde
semanticscholar +1 more source
Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA [PDF]
, 2008 The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use.
A. P. Fletcher +19 more
core +2 more sources
Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer
Iranian Journal of Neurosurgery, 2019 Background and Aim: Cranfixer was approved in 2017 by the Food and Drug Administration of Iran as a skull flap fixation and also a burr hole cover.
Seyed Roholah Ghodsi +3 more
doaj