Results 21 to 30 of about 5,527 (127)

Pharmacokinetics and Safety Evaluation of a New Generic Sitafloxacin: A Phase I Bioequivalence Study in Healthy Chinese Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Sitafloxacin is a new antibiotic drug belonging to the fourth generation quinolone antibiotics. The aim of this study was to evaluate the pharmacokinetics (PK), safety profiles, and bioequivalence of test and reference 50‐mg sitafloxacin tablets under fasting and fed conditions.
Yongfang Lei, Pan Luo, Yuzhu Chen, Liuliang Xue, Donglin Zhang, Xingxing Qi, Yinian Fang, Hengyi Yu, Zheng He, Qin Zuo, Chang Liu, Dong Liu, Xinhua Ren, Qian Chen   +13 more
wiley   +1 more source

Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape

Small, EarlyView.
This review presents a detailed overview of clinically approved nanoparticle therapeutics, classifying them by type and discussing their unique advantages in drug delivery. It highlights regulatory challenges across global markets and emphasizes the need for adaptive approval pathways.
Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K. Vora   +5 more
wiley   +1 more source

Effectiveness and Safety of Guselkumab in Patients With Moderate‐to‐Severe Plaque Psoriasis in Real‐World Practice in Korea: A Prospective, Multicenter, Observational, Postmarketing Surveillance Study

The Journal of Dermatology, EarlyView.
ABSTRACT Clinical trials have demonstrated the efficacy and safety of guselkumab in patients with moderate‐to‐severe plaque psoriasis. Real‐world evidence for guselkumab in Korea is needed to establish drug safety and effectiveness under real‐world practice in this population.
Bong Seok Shin, Miri Kim, Moo Kyu Suh, Young Bok Lee, Sang Woong Youn, Ji Yeoun Lee, Chul Woo Kim, Ga‐Young Lee, Sang Wook Son, Kwang Ho Kim, Jihye An, Youngdoe Kim, Kwang Joong Kim, Dong Hyun Kim   +13 more
wiley   +1 more source

Safety of opioid patch initiation in Australian residential aged care [PDF]

, 2015
Explores opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Abstract Objective: To explore opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Design:
Elizabeth Roughead, Lisa Pont, Svetla Gadzhanova   +2 more
core   +1 more source

Clinical Characteristics and Safety Profiles of Japanese Psoriasis Patients Who Continued Apremilast Treatment for 6 and 12 Months: A Post Hoc Analysis of an Apremilast Postmarketing Surveillance Study

The Journal of Dermatology, EarlyView.
ABSTRACT Apremilast is a phosphodiesterase 4 inhibitor approved for moderate to severe psoriasis in Japan. Apremilast significantly improved Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) both at 6 and 12 months in a previously published primary post‐surveillance study.
Mamitaro Ohtsuki, Yukari Okubo, Hidehisa Saeki, Atsuyuki Igarashi, Shinichi Imafuku, Masatoshi Abe, Katsuya Saito, Ryuichi Ogawa, Akimichi Morita   +8 more
wiley   +1 more source

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, Becky Bishop, Vikki Mangano, Baher Mankabady   +3 more
wiley   +1 more source

Glycoprotein IIb/IIIa Inhibitors Use and Outcome after Percutaneous Coronary Intervention for Non-ST Elevation Myocardial Infarction [PDF]

, 2014
Aims. We investigate the effect of glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors on long-term outcomes following percutaneous coronary intervention (PCI) after non-ST elevation myocardial infarction (NSTEMI). Meta-analyses indicate that these agents are
Antoniou, S, Gallagher, S, Howard, JP, Jones, DA, Knight, C, Mathur, A, Rathod, K, Weerackody, R, Wragg, A, Wright, P   +9 more
core   +4 more sources

Postmarketing safety of migraine prophylactic monoclonal antibodies: An EudraVigilance database analysis of eptinezumab, fremanezumab, galcanezumab, and erenumab

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, Greta Santi Laurini, Nicola Montanaro, Domenico Motola   +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  

Monitoring Temporal Changes in the Specificity of an Oral HIV Test: A Novel Application for Use in Postmarketing Surveillance [PDF]

, 2010
BACKGROUND: Postmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to ...
Jessica M. Borrelli, JG Elmore, Joseph R. Egger, Julia Cummiskey, K Jafa, Kevin J. Konty, KJ Henning, LG Wesolowski, M Kulldorff, Nitika Pant Pai, R Heffernan, S Gottlieb, Susan Blank, T Jelinek   +13 more
core   +3 more sources