Results 131 to 140 of about 190,239 (217)

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

Retrospective cohort study of mRNA COVID-19 vaccine-associated enhanced disease in the Vaccine Safety Datalink, 2021-23. [PDF]

Hum Vaccin Immunother
Belongia EA, Kieke BA, Hanson KE, McClure DL, Boyce TG, Daley MF, DeSilva MB, Hurley LP, Irving SA, Jackson LA, Duffy J, McNeil MM, Sundaram ME.   +12 more
europepmc   +1 more source

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

Can We Compare Adverse Events' Attributable Risk Using a Self-Controlled Case Series Design for Vaccine Safety? A Guillain-Barré Syndrome Use Case. [PDF]

Infect Dis Ther
Liang C, Chilson EL, Wu J, Kelly SP, Liu Q, Dooling KL, Lino MM, Lewnard JA, Gessner BD, Begier E.   +9 more
europepmc   +1 more source

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

Bivalent RSVpreF Subunit Vaccine Safety and Immunogenicity in Seropositive 2-<18 Year Olds. [PDF]

Vaccines (Basel)
Glanternik J, Paulsen GC, Senders S, Smith M, Shittu E, Pahud BA, Pereira L, Chen L, Maddalena Lino M, Kalinina EV, Baranova D, Kalina WV, Needle E, Murillo M, Leech JM, Cooper D, Swanson KA, Anderson AS, Gurtman A, Munjal I.   +19 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

Harmonizing Case Validation for Vaccine Safety in Real-World Data: The VAC4EU Experience. [PDF]

Clin Epidemiol
Dehghan Tarazjani A, Weibel D, Aurelius T, Zwiers LC, Van den Berg JM, Pérez-Breva L, Gimeno-Miguel A, Stona L, Solórzano M, Desalegn AA, Poblador-Plou B, Lysen TS, Wheler J, Zidan M, Carreras JJ, Villalobos F, Ehrenstein V, Morton K, Rebordosa C, Ahmadizar F, Fortuny J, Arana A, Sturkenboom M.   +22 more
europepmc   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 more
wiley   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway. [PDF]

Br J Clin Pharmacol
Dzus TE, Sarrage J, Samdal H, Montastruc F, Rocca E.   +4 more
europepmc   +1 more source