Results 161 to 170 of about 31,009,639 (254)

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

Redox control and mechanisms of transmembrane signaling in CSS domain c-di-GMP phosphodiesterases that control biofilm formation in <i>Escherichia coli</i>. [PDF]

mBio
Pressler K, Lorkowski M, Hengge R.
europepmc   +1 more source

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source

c-di-GMP-mediated pause behavior enables <i>Pseudomonas aeruginosa</i> navigation in porous environments. [PDF]

Appl Environ Microbiol
Zhang Z, Zhang R, Yuan J.
europepmc   +1 more source

Safety and pharmacokinetics of inhaled aloxistatin: A first‐in‐human phase 1 dose escalation trial

British Journal of Clinical Pharmacology, EarlyView.
Aims Aloxistatin (E64d) is a membrane‐permeable cysteine protease inhibitor prodrug that is converted by esterases to the active metabolite E64c (loxistatin). This first‐in‐human study evaluated the safety, tolerability and pharmacokinetics of single ascending doses of inhaled E64d in healthy volunteers.
Sebastian Fähndrich, Franziska Friedrich, Daniel Soriano, Jona Gjeloshi, Björn C. Frye, Xuan Phuoc Nguyen, Lydia Herbstritt, Caroline von Spee‐Mayer, Britta Lang, Fabrice Nollevaux, Andreas Hoheisel, Dorothee Winterberg, Armin Braun, Thomas Epting, Christine Contini, Karl Winkler, Thomas Reinheckel, Franziska C. Trudzinski, Gernot Rohde, Daiana Stolz, Robert Bals, Martin J. Hug, Sebastian Wirtz, Christoph Peters, Carolin Jenkner   +24 more
wiley   +1 more source

Discovery of Novel c-di-GMP-Related Genes in <i>Leptospira interrogans</i>. [PDF]

Pathogens
Ferrari ASA, Merighi DGS, Visnardi AB, Silva GR, Gonçalves CAB, Sanchez-Limache DE, Ogusku BSC, Souza AS, de Souza RF, Guzzo CR.   +9 more
europepmc   +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

A nutrient-sensing protease DegS suppresses biofilm formation in <i>Vibrio cholerae</i> via the CdgH-c-di-GMP-VpsR axis under nutrient limitation. [PDF]

Biofilm
Huang X, Chen T, Linghu Q, Wang H, Luo S, Zhou H, Min X, Huang J.   +7 more
europepmc   +1 more source

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

Biotechnology and Bioengineering, EarlyView.
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga, Udisha Singh, Sachin Dattram Pawar   +2 more
wiley   +1 more source

Understanding c-di-GMP-mediated regulation of flagellar motility, one step at a time. [PDF]

J Bacteriol
O'Toole GA.
europepmc   +1 more source