Results 41 to 50 of about 25,471 (263)

Teriparatide Did Not Increase Adult Osteosarcoma Incidence in a 15‐Year US Postmarketing Surveillance Study

Journal of Bone and Mineral Research, 2020
The Osteosarcoma Surveillance Study was initiated in the United States in 2003 to monitor for a potential association between the osteoporosis treatment teriparatide and osteosarcoma.
A. Gilsenan, K. Midkiff, D. Harris, N. Kellier‐Steele, D. Mcsorley, E. Andrews   +5 more
semanticscholar   +1 more source

Incomplete Resolution of Deep Vein Thromboses during Rivaroxaban Therapy. [PDF]

, 2017
We present the case of a patient with a deep vein thrombosis (DVT) who failed rivaroxaban therapy. Our patient initially presented with left lower extremity edema, erythema, and pain.
Adashek, Jacob, Ben-Zur, Uri M, Nagar, Menachem, Pietras, Richard J, Toomari, Nojan, Yaghoubian, Jonathan M, Yaghoubian-Yazi, Bahareh   +6 more
core   +5 more sources

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements [PDF]

, 2018
The United States Food and Drug Administration (FDA) has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs
Naci, Huseyin, Ross, Joseph S., Wallach, Joshua D.   +2 more
core   +1 more source

Safety Assessment of High- and Low-Molecular-Weight Hyaluronans (Profhilo®) as Derived from Worldwide Postmarketing Data

BioMed Research International, 2020
Background At present, dermal fillers based on hyaluronic acid (HA) represent the most popular intervention of dermoesthetic medicine for the treatment of skin aging.
D. Cassuto, Mara Delledonne, Giovanna Zaccaria, Immacolata Illiano, A. Giori, G. Bellia   +5 more
semanticscholar   +1 more source

Improving the external validity of clinical trials: the case of multiple chronic conditions [PDF]

, 2013
The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions (MCCs) incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will ...
Fortin, Martin, Smith, Susan M.
core   +4 more sources

Trends and characteristics of accidental and intentional codeine overdose deaths in Australia [PDF]

, 2015
Examines trends in codeine-related mortality rates in Australia, and the clinical and toxicological characteristics of codeine-related deaths. Abstract Objectives: To examine trends in codeine-related mortality rates in Australia, and the clinical and ...
Amanda Roxburgh, Eva Saar, Jennifer Pilgrim, Louisa Degenhardt, Lucinda Burns, Suzanne Nielsen, Wayne D Hall   +6 more
core   +1 more source

Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies

Pharmaceuticals, 2023
Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of ...
Valerio Ciccone, Marina Ziche, Andrea Spini, Sandra Donnini   +3 more
doaj   +1 more source

Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study

Annals of the Rheumatic Diseases, 2017
Objectives There is a need for effective and safe treatment during pregnancy in women with chronic inflammatory diseases. This study evaluated placental transfer of certolizumab pegol (CZP), an Fc-free anti-tumour necrosis factor drug, from CZP-treated ...
X. Mariette, F. Förger, Bincy T. Abraham, A. Flynn, A. Moltó, R. Flipo, A. V. van Tubergen, L. Shaughnessy, J. Simpson, M. Teil, E. Helmer, Maggie Wang, E. Chakravarty   +12 more
semanticscholar   +1 more source

Development of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real‐World Data From Electronic Health Records

Clinical pharmacology and therapy, 2020
Postmarketing population pharmacokinetic (PK) and pharmacodynamic (PD) studies can be useful to capture patient characteristics affecting PK or PD in real‐world settings.
Leena Choi, C. Beck, Elizabeth McNeer, H. Weeks, Michael L. Williams, N. James, X. Niu, B. Abou-Khalil, K. Birdwell, D. Roden, C. Stein, C. Bejan, J. Denny, S. V. Van Driest   +13 more
semanticscholar   +1 more source

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada

Therapeutic Advances in Drug Safety, 2019
Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj, Swapnil Fernandes, Narayana R. Charyulu, Akhilesh Dubey, Ravi G. S., Srinivas Hebbar   +5 more
doaj   +1 more source