Results 61 to 70 of about 5,946 (190)

Regulating risks in pharmaceutical law : the need of an optimal interplay between products safety and products liability [PDF]

open access: yes, 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

open access: yesJournal 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

Self-controlled case series with multiple event types [PDF]

open access: yes, 2017
Self-controlled case series methods for events that may be classified as one of several types are described. When the event is non-recurrent, the different types correspond to competing risks.
Douglas, Ian J.   +4 more
core   +1 more source

Nelarabine Associated Myotoxicity and Rhabdomyolysis

open access: yesCase 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

Advancing Maternal Health with Long‐Acting Therapeutics: Priorities, Efficacy and Safety Considerations, and Emerging Technologies

open access: yesClinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1179-1194, May 2026.
Maternal health remains a critical global concern, particularly in underserved populations and in low‐ and middle‐income countries where access to safe and effective therapeutics is limited. Despite the use of medications by most women during pregnancy, the exclusion of pregnant and lactating women from clinical trials has resulted in significant data ...
Rachel K. Scott   +7 more
wiley   +1 more source

A Comparison of Regional Decisions for Doses and Administrations of New Drugs: Concordance, Discordance, and Dependencies

open access: yesClinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1350-1361, May 2026.
Regional differences in approved drug dosages and administration are shaped by complex factors, including clinical data, prior regulatory decisions, and region‐specific considerations. This study investigated how such factors are associated with variations in approved doses across the United States Food and Drug Administration (FDA), European Medicines
Sachiko Mita, Shunsuke Ono
wiley   +1 more source

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

open access: yes, 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  

Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer

open access: yesIranian 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  

Adverse Events of Saffron (Crocus sativus L.): Systematic Review of Current Evidence

open access: yesHealth Science Reports, Volume 9, Issue 5, May 2026.
ABSTRACT Background Crocus sativus L., commonly known as saffron, is a widely used spice with a rich history of culinary and medicinal applications. This systematic review aims to compile human data from studies on monopreparations of C. sativus, including stigma powder and other extracts, to evaluate their safety.
Fatemeh Sadat Hasheminasab   +3 more
wiley   +1 more source

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