Results 111 to 120 of about 21,353 (254)

A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]

, 2007
This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
core   +1 more source

The role of natalizumab in the treatment of multiple sclerosis: benefits and risks

Therapeutic Advances in Neurological Disorders, 2017
Natalizumab, a monoclonal antibody that blocks lymphocyte infiltration in the central nervous system, is a valuable tool in the treatment of relapsing forms of multiple sclerosis (MS). In a phase III clinical trial comparing natalizumab with placebo over
Barry A. Singer
doaj   +1 more source

Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis

Lupus Science and Medicine
Objective The present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods Adverse event (AE) reports in the FAERS ...
Huqun Li, Wenlong Xie, Chongshu Wang, Cuilian Guo   +3 more
doaj   +1 more source

Characteristics of “Hard-to-Use” Press-Through-Package Sheets: An Analysis of Information Collected by Marketing Specialists of a Japanese Medical Wholesaler

Patient Preference and Adherence, 2020
Kenji Kabeya,1 Hiroki Satoh,2,3 Satoko Hori,4 Yasumasa Miura,5 Yasufumi Sawada2 1Faculty of Pharmaceutical Sciences, The University of Tokyo, Tokyo 113-0033, Japan; 2Laboratory of Drug Lifetime Management, Graduate School of Pharmaceutical Sciences, The ...
Kabeya K, Satoh H, Hori S, Miura Y, Sawada Y   +4 more
doaj  

Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data [PDF]

, 2022
Hideki Terai, Kenzo Soejima, Asanao Shimokawa, Hidehito Horinouchi, Junichi Shimizu, Tetsunari Hase, Ryota Kanemaru, Kana Watanabe, Kiichiro Ninomiya, Naoko Sueoka‐Aragane, Noriko Yanagitani, Yoshihiko Sakata, Masahiro Seike, Daichi Fujimoto, Masashi Kasajima, Akihito Kubo, Sojiro Kusumoto, Yoshitaka Oyamada, Keiichi Fujiwara, Masahide Mori, Midori Hashimoto, Masato Shingyoji, Masahiro Kodani, Jin Sakamoto, Toshihiko Agatsuma, Kosuke Kashiwabara, Minehiko Inomata, Motoko Tachihara, Kazuhisa Tanaka, Kenji Hayashihara, Nobuyuki Koyama, Kaoru Matsui, Koichi Minato, Daisuke Jingu, Hiroyuki Sakashita, Satoshi Hara, Tomoyuki Naito, Asuka Okada, Masayuki Tanahashi, Yuki Sato, Koichiro Asano, Takayuki Takeda, Kensuke Nakazawa, Toshiyuki Harada, Kazuhiko Shibata, Tatsuo Kato, Etsuo Miyaoka, Ichiro Yoshino, Akihiko Gemma, Tetsuya Mitsudomi   +49 more
openalex   +1 more source

Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results [PDF]

, 2017
Background: Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy,
Argüelles Arias, Federico, Castro Laria, Luisa, Guerra Veloz, María Fernanda, Maldonado Pérez, Belén, Merino Bohórquez, Vicente, Perea Amarillo, Raúl, Romero Gómez, Manuel, Vilches Arenas, Ángel   +7 more
core  

Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease [PDF]

, 2017
R. V Deev, I. L. Plaksa, I. Y Bozo, А. А. Исаев   +3 more
openalex   +1 more source

Incentivizing the Utilization of Pharmacogenomics in Drug Development [PDF]

, 2012
Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions ...
Koch, Valerie Gutmann
core   +1 more source

Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients [PDF]

, 2012
Takao Koike, Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Shuji Takei, Tsutomu Takeuchi, Hisashi Yamanaka, Yoshiya Tanaka   +7 more
openalex   +1 more source

Anamu, moringa, spirulina, and chlorella: Contribution to the quality of life of oncology patients: Results of the postmarketing prospective study performed in Serbia in 2021 - 2022 [PDF]

, 2023
Garcia Estevez, Vladimir Kovčin, Godinez Venegas   +2 more
openalex   +1 more source