Results 171 to 180 of about 2,769,024 (292)

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

British Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló, Attila Imre, Gábor Varga, Sándor Kovács, György Tímár, Balázs Nagy   +5 more
wiley   +1 more source

Author Correction: Changes in vaccine attitudes and recommendations among US Healthcare Personnel during the COVID-19 pandemic

npj Vaccines
Matthew Z. Dudley, Holly B. Schuh, Amanda Forr, Jana Shaw, Daniel A. Salmon   +4 more
doaj   +1 more source

Adaptive Sequential Multiple Hypotheses Testing for Concomitant Vaccine Safety Surveillance. [PDF]

Stat Med
Silva IR, Wang L, Maro JC.
europepmc   +1 more source

Safety events: planning the immediate media response: World Health Organization vaccine safety supporting document

, 2017
4 p.Vaccine-safety-related events, and how we respond to them, can affect public trust in vaccines and health authorities. These events may or may not be linked to vaccines and include: adverse events following immunization (AEFIs), vaccination programme
World Health Organization. Regional Office for Europe
core  

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Vaccine safety surveillance during an mpox outbreak, Germany, June 2022 to February 2024. [PDF]

Euro Surveill
Oberle D, Hofmann A, Jansen K, Koppe U, Lachmann R, Streit R.   +5 more
europepmc   +1 more source

How to respond to concerns about vaccination: World Health Organization vaccine safety supporting document

, 2015
2 p.Vaccine-safety-related events, and how we respond to them, can affect public trust in vaccines and health authorities. These events may or may not be linked to vaccines and include: adverse events following immunization (AEFIs), vaccination programme
World Health Organization. Regional Office for Europe
core  

Efficacy, safety and cost‐effectiveness of CAR‐T therapy

British Journal of Clinical Pharmacology, EarlyView.
CAR T‐cells demonstrate high efficacy in blood cancers, including ALL, MM and DLBCL. Innovations target solid tumours despite challenges such as antigen escape. Combination therapies enhance the delivery and infiltration of CAR T cells. Toxicity, cost and resistance remain major barriers to clinical use.
Emina Karahmet Sher, Amina Džidić‐Krivić, Emma Pinjic, Nejra Selak, Kanita Omerbasic, Alexandar Chupin, Andrej Belancic, Almir Fajkic   +7 more
wiley   +1 more source

MVA-BN monkeypox vaccine safety in a clinical trial in the Democratic Republic of the Congo. [PDF]

NPJ Vaccines
Ntamabyaliro N, Bonnett T, Potter G, Yox E, Liesenborghs L, Mbaya OT, Nussenblatt V, Kilara TK, Engo AB, Muhima E, Velela P, Itunime L, Biampata JL, Mbala P, Lusakibanza M, Basika MK, Tona G, Vogel S, Lane HC, Dodd LE, Muyembe JJ.   +20 more
europepmc   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source