Results 161 to 170 of about 183,515 (258)

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Acceptability of patient-centered digital vaccine safety monitoring: A Canadian Immunization Research Network study. [PDF]

Hum Vaccin Immunother
Ellis-Legault B, Wilson K, Greyson D, Shulha HP, Nilormi A, Bettinger JA.   +5 more
europepmc   +1 more source

The impact of medication shortages on paediatric care: A retrospective impact analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg, Laurens Christiaan van Rijn, Elisabeth Johanna Ruijgrok, Sinno Henricus Paulus Simons, Brigitta Carolina Maria Witjes, Jan‐Dietert Christoffer Brugma, Robert Bernard Flint   +6 more
wiley   +1 more source

Establishing an Active Vaccine Safety Surveillance System Using Large Scale Databases in Korea: Lessons and Scalable Insights for Global Application. [PDF]

J Korean Med Sci
Yoon JG, Nham E, Choi YJ, Choi MJ, Choi WS, Yoon YK, Seo YB, Hyun H, Heo JY, Lee JS, Kim CJ, Noh JY, Song JY, Cheong HJ.   +13 more
europepmc   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

Using double-negative controls to adjust for healthy-user bias in a recombinant zoster vaccine safety study. [PDF]

Am J Epidemiol
Li K, Emerman I, Cook AJ, Fireman BH, Sundaram M, Tseng HX, Weintraub ES, Yu O, Nelson JL, Shi X.   +9 more
europepmc   +1 more source

Young children's right to be heard on the quality of their education: Addressing potential misunderstandings in the context of early childhood education

British Educational Research Journal, EarlyView.
Abstract In early childhood education many researchers and professionals across the world have embraced the United Nations Convention on the Rights of the Child's requirement to include young children in decision‐making. In the context of ongoing discussion about young children's capacity to share their views and opinions about matters affecting them ...
Laura Lundy, Colette Murray, Kylie Smith, Carmel Ward   +3 more
wiley   +1 more source

Continuous Purification of mRNA Produced by In Vitro Transcription Using High Performance Countercurrent Membrane Purification

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Messenger ribonucleic acid (mRNA) therapeutics produced by in vitro transcription must be purified to remove residual enzymes and free nucleotides. This study examines the use of high‐performance countercurrent membrane purification (HPCMP) for the purification of mRNA therapeutics based on differences in the rate of diffusion across ...
Ziqiao Wang, Amin Javidanbardan, Ali Behboudi, Andrew L. Zydney   +3 more
wiley   +1 more source

What Makes an “Ideal” Cell Line for Recombinant Adeno‐Associated Virus Production?

Biotechnology and Bioengineering, EarlyView.
Several host cell types have been used to produce rAAVs to date. Cell line‐specific traits that are beneficial in the context of rAAV manufacturing are reviewed here, with the goal of developing a consensus on the ‘ideal’ characteristics that an rAAV production host should possess (created with Biorender.com).
James Conheady, Nicholas Donohue, Alexandra Bogdanovic, Sharon Davin, Brian Glennon, Niall Barron, C. Mark Smales   +6 more
wiley   +1 more source

Vaccination During Pregnancy in the Vaccine Safety Datalink, 2002-2022. [PDF]

Pediatr Infect Dis J
Naleway AL, Crane B, Irving SA, Daley MF, Dixon B, Donahue J, Fuller CC, Fuller S, Getahun D, Glenn S, Hambidge SJ, Jackson LA, Kharbanda EO, Klein NP, Schmidt T, Sznajder K, Weinfield NS, Williams JTB, Zerbo O.   +18 more
europepmc   +1 more source