Results 201 to 210 of about 2,076,500 (256)

Harnessing cytokines: innovative adjuvants for improved veterinary vaccine efficacy. [PDF]

Front Immunol
Yan S, Chen H, Liu Q, Zhang X, Wei Q, Hu C, Chu D, Diao H, Liu S, Chen JL.   +9 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

Impact of obesity on COVID-19 CoronaVac and ChAdOx1-S vaccine efficacy. [PDF]

BMC Infect Dis
Cortez MV, Martins A, Nascimento J, Chui FMDS, Rodrigues MGA, Bastos T, Lemos SM, Honorato E, Gomes E, Abreu-Netto RL, Fernandes S, Silva-Neto AV, Sachett A, Silva BM, Mouta GS, Cordeiro JSM, Baía-da-Silva DC, Brito-Sousa JD, Pessoa KP, Monteiro W, Naveca F, Sampaio V, Almeida-Val F, Melo G, Mourão MP, Lacerda M.   +25 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

Modulation of oral vaccine efficacy by the gut microbiota. [PDF]

NPJ Vaccines
Hou Y, Li J, Wu Y.
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

Application of luminescence-producing Mycobacterium tuberculosis strains for evaluating anti-tuberculosis drug and vaccine efficacy in vitro and in vivo. [PDF]

BMC Infect Dis
Kim SM, Shin E, Yun JS, Jeon J, Park S, Jung YW, Kim D, Jeong HS.   +7 more
europepmc   +1 more source

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan, Christopher Banfield, Kenneth Hung, Anna Sapone, Vivek Pradhan, Yuxi Zhao, Dana Parsons‐Rich, Grace Lee, Bryce G. Johnson, Elena Peeva, Michael S. Vincent, Valerie M. Clerin   +11 more
wiley   +1 more source

Gut microbiota as a regulator of vaccine efficacy: implications for personalized vaccination. [PDF]

Gut Microbes
Lu Q, Feng Y, Wang H, Zhu K, Teng L, Yue M, Li Y.   +6 more
europepmc   +1 more source

British National Formulary Guidance on prescribing in pregnancy: A descriptive cross‐sectional study

British Journal of Clinical Pharmacology, EarlyView.
Aim To assess how well pregnancy‐specific guidance within the British National Formulary supports healthcare professionals to facilitate safe and effective medication use. Methods We performed a manifest content analysis of the text of all pregnancy sections within British National Formulary drug monographs, with inductive and iterative coding.
Hannah Johnson, Cleodie Swire, Lakshiv Dhingra, Toqa El‐Nahhas, Michelle Essiam, Salma Muse, Maria Tonkova, Nazmin Begum, Joan Morris, Emma Baker   +9 more
wiley   +1 more source