Results 51 to 60 of about 80,404 (95)

Xioglican Cream in Italian Patients with Chronic Venous Disease: A Post-Marketing Study Investigating Effects on Clinical and Cutaneous Signs and Symptoms. [PDF]

Adv Ther, 2023
Muratori IM, Contorno F, Amato C.
europepmc   +1 more source

Adverse Reactions to Evolocumab: Analysis of Real-World Data from EudraVigilance

Pharmaceuticals
Background: Evolocumab is a humanized immunoglobulin G2 monoclonal antibody, directed against Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), prescribed in hypercholesterolemic patients.
Fabrizio Calapai, Carmen Mannucci, Mariaconcetta Currò, Luigi Cardia, Emanuela Esposito, Gioacchino Calapai, Ilaria Ammendolia   +6 more
doaj   +1 more source

Plerixafor stem cell mobilization in Japanese children: A post-marketing study. [PDF]

Pediatr Int, 2022
Goto H, Kanamori R, Nishina S, Seto T.
europepmc   +1 more source

A Real-World Study of Safety, Immunogenicity and Efficacy of Bevacizumab in Patients With Solid Malignancies: A Phase IV, Post-Marketing Study in India. [PDF]

Cancer Inform, 2023
Sinha SD, Biswas G, Bheemareddy BR, Chary S, Thakur P, Jain M, Maksud T, Pawar S, Chatterjee K, Voonna MK, Goel A, Puligundla KC, Lakshmaiah KC, Talluri L, Vattipalli R, Kakkunnath S.   +15 more
europepmc   +1 more source

Safety and tolerability of agalsidase beta infusions shorter than 90 min in patients with Fabry disease: post-hoc analysis of a Japanese post-marketing study. [PDF]

Orphanet J Rare Dis, 2023
Lee CS, Tsurumi M, Eto Y.
europepmc   +1 more source

An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients. [PDF]

Tuberc Respir Dis (Seoul), 2023
Cho EY, Cho JE, Lee EB, Yoo SS, Chang JH.   +4 more
europepmc   +1 more source

Phase IV of Drug Development

Perspectives in Clinical Research, 2010
Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study. Phase IV is also an important phase of drug development.
Viraj Suvarna
doaj  

Safety of heterologous ChAdOx1-S/BNT162b2 primary schedule versus homologous BNT162b2 vaccination: Insights from an Italian post-marketing study, 2021. [PDF]

Hum Vaccin Immunother, 2023
Fortunato F, Prato R, Iannelli G, Ascatigno L, Loconsole D, Lopalco PL, Martinelli D.   +6 more
europepmc   +1 more source

Post-marketing surveillance framework of cell and gene therapy products in the European Union, the United States, Japan, South Korea and China: a comparative study

BMC Medicine
Background Cell and gene therapy products (CGTPs) often receive accelerated approvals, lacking comprehensive long-term safety and efficacy data, which can raise significant safety concerns. This research aims to study the post-marketing surveillance (PMS)
Yuxin Cai, Lijuan Sui, Jingjing Wang, Weilin Qian, Yeheng Peng, Luyao Gong, Weijia Wu, Yuan Gao   +7 more
doaj   +1 more source

Safety and Effectiveness of Lenvatinib in Patients with Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice: An Observational Post-Marketing Study in Japan. [PDF]

Drugs Real World Outcomes, 2023
Furuse J, Izumi N, Motomura K, Inaba Y, Katamura Y, Kondo Y, Yabushita K, Motoyoshi K, Kudo M.   +8 more
europepmc   +1 more source