Results 101 to 110 of about 21,353 (254)

Underreporting of Major Cardiac Adverse Events With Immune Checkpoint Inhibitors in Clinical Trials: Importance of Postmarketing Pharmacovigilance Surveys

, 2022
Pascale Palassin, Jean‐Luc Faillie, Cyrille Coustal, Xavier Quantin, Delphine Topart, François Roubille, A. Maria   +6 more
openalex   +2 more sources

Assessment of malignancy risk in patients with multiple sclerosis treated with intramuscular interferon beta-1a: retrospective evaluation using a health insurance claims database and postmarketing surveillance data

Therapeutics and Clinical Risk Management, 2012
Gary Bloomgren, Bjørn Sperling, Kimberly Cushing, Madé WentenBiogen Idec Inc., Weston, MA, USABackground: Intramuscular interferon beta-1a (IFNβ-1a), a multiple sclerosis (MS) therapy that has been commercially available ...
Bloomgren G, Sperling B, Cushing K, Wenten M   +3 more
doaj  

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  

An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice [PDF]

, 2012
Background: Medication registration currently requires evidence of safety and efficacy from adequately powered phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting) provide data on more widespread and
Abernethy, Amy Pickar, Currow, David Christopher, Doogue, Matthew, Rowett, Debra Sharon, To, Timothy H M   +4 more
core   +1 more source

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
A Bate, A Clarke, A Pariente, AK Chung, Ariola Koci, B Darpo, BJ Drew, C Meyer-Massetti, DM Roden, DW Hough, E Poluzzi, E Poluzzi, E Poluzzi, E Raschi, E Raschi, Edoardo Spina, Elijah R. Behr, Elisabetta Poluzzi, Emanuel Raschi, EP Puijenbroek van, ER Behr, F Ponti De, F Ponti De, F Rani, Fabrizio De Ponti, GC Alexander, GK Isbister, H Verdoux, J Nielsen, J Papay, K Jolly, K Titier, LC Wittkampf, LS Schneider, Miriam Sturkenboom, NP Tatonetti, P Kannankeril, P Manu, P Vigneault, RC Owens Jr, RR Shah, S Dhillon, S Hennessy, S Kongsamut, S Leucht, SM Straus, Ugo Moretti, W Crumb, W Crumb, WA Ray, WA Ray, WJ Crumb Jr, WP Stephenson, Y Suzuki   +53 more
core   +4 more sources

Postmarketing Surveillance of the Safety of Cyclic Etidronate [PDF]

, 1998
Tjeerd van Staa, H.G.M. Leufkens, Lucien Abenhaim, Cyrus Cooper   +3 more
openalex   +1 more source

Clinical outcomes in adult patients with plaque psoriasis treated with ustekinumab under real‐world practice in Korea: A prospective, observational, multi‐center, postmarketing surveillance study

, 2021
Sang Woong Youn, Dae Young Yu, Byung‐Soo Kim, Youngdoe Kim, Kwang Joong Kim, Jee‐Ho Choi, Sang Wook Son, Eun‐So Lee, Young Suck Ro, Young Lip Park, YoungJa Lee, Jeung Hoon Lee, Hyun Jeong Park, Tae‐Yoon Kim, Min‐Geol Lee, Min Kyung Shin, Gwang Seong Choi, Dong Hyun Kim, Seong Jin Jo, Seung Chul Lee, the Stelara PMS investigators   +20 more
openalex   +2 more sources

Postmarketing safety experience with edoxaban in Japan for thromboprophylaxis following major orthopedic surgery

Vascular Health and Risk Management, 2013
Yasufumi Kuroda,1 Chie Hirayama,2 Hitoshi Hotoda,2 Yasuhiro Nishikawa,2 Akinori Nishiwaki21Daiichi Sankyo Pharma Development, Edison, NJ, USA; 2Daiichi Sankyo Company, Limited, Tokyo, JapanPurpose: Edoxaban is an oral, once-daily, selective, direct ...
Kuroda Y, Hirayama C, Hotoda H, Nishikawa Y, Nishiwaki A   +4 more
doaj  

What is the addiction risk associated with tramadol? [PDF]

, 2005
Tramadol (Ultram, generic and with acetaminophen in Ultracet) carries a risk of substance abuse (strength of recommendation [SOR]: B, based on case report surveillance programs).
Mackler, Leslie, McDiarmid, Todd
core  

EFFECTIVENESS AND SAFETY OF 1% PIMECROLIMUS CREAM AS APPLIED AMONG CHILDREN WITH ATOPIC DERMATITIS

Педиатрическая фармакология, 2009
The article highlights the findings of the open surveying uncontrolled multicentric postmarketing research to study the effectiveness and safety of 1% pimecrolimus cream as applied among children aged over months, suffering from atopic dermatitis.
K.E. Efendieva, Yu.G. Levina, L.S. Namazova-Baranova   +2 more
doaj   +2 more sources