Results 221 to 230 of about 9,681,672 (299)

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

A computational model of spatial politics: Hotelling-downs model as statistical physics. [PDF]

PLoS One
Campbell C, Ackland GJ.
europepmc   +1 more source

Implementation and use of risk minimization control tools in the EU: A multistakeholder survey

British Journal of Clinical Pharmacology, EarlyView.
Aims This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries. Methods We conducted
Sharon C. M. Essink, Iris R. Joosse, Maximilian Salcher‐Konrad, Melanie Walter, Elena Deligianni, Dimitra Tsioumela, Christos Kontogiorgis, Elita Poplavska, Iluta Žīgure, Christina E. Hoeve, Teresa Leonardo Alves, Ella D. van Vliet, Renato Ferreira‐da‐Silva, Ana Kodrič, Mitja Kos, Juan Erviti, Marta Gutiérrez‐Valencia, Luis Carlos Saiz, Sofia Kälvemark Sporrong, Emelie Karlsson, Christine Leopold, Marie L. De Bruin   +21 more
wiley   +1 more source

New policies, old habits: why and how Dutch mental healthcare moves towards collaboration. [PDF]

Int J Ment Health Syst
van Dijk TS, de Koning C, Felder M, van der Scheer WK, Janssen RTJM.   +4 more
europepmc   +1 more source

The integrated Lei‐CNS PBPK‐PD model effectively predicts clozapine brain disposition and D2 receptor occupancy in humans

British Journal of Clinical Pharmacology, EarlyView.
Aim Clozapine, used for treatment‐resistant schizophrenia, has a narrow therapeutic window and highly variable plasma pharmacokinetics (PK), necessitating careful monitoring. Direct measurement of unbound brain PK in humans is unethical. To develop a physiologically based pharmacokinetic–pharmacodynamic (PBPK‐PD) model to predict clozapine brain ...
Mengxu Zhang, Thomas I. F. H. Cremers, Vivi Rottschäfer, Elizabeth C. M. de Lange   +3 more
wiley   +1 more source

Acute toxic leucoencephalopathy following protonitazene ingestion

British Journal of Clinical Pharmacology, EarlyView.
Background Distribution of illicit counterfeit alprazolam containing the highly potent synthetic opioid‐receptor agonist protonitazene recently resulted in a number of severe overdoses in Ireland. We report three cases that presented to our hospital, within 6 weeks of one another, following ingestion of illicitly‐sourced alprazolam.
Ruadhan O'Laoi, Holly Acton, Pierce Kavanagh, Isabelle Hunt, Niall Sheehy, Cormac Kennedy   +5 more
wiley   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

Economic evaluations of antiobesity medications: A systematic literature review

British Journal of Clinical Pharmacology, EarlyView.
The global prevalence of obesity is rising rapidly. With several antiobesity medications approved and many more in development, understanding their economic value is increasingly important. This study reviews full economic evaluations of approved antiobesity medications to assess cost‐effectiveness and inform reimbursement and access decisions.
Martina Jurković, Almir Fajkić, Andrea Katrin Faour, Mirna Momčilović, Petra Turčić, Andrej Belančić   +5 more
wiley   +1 more source

EUPopLink Country Report - Italy. [PDF]

Open Res Eur
Lorimer M.
europepmc   +1 more source

Researchers' perspectives on the use of material transfer agreements in biobanking research; a case of Uganda. [PDF]

BMC Med Ethics
Namuddu R, Nabukenya S, Balwa H, Munabi I, Mwaka E.   +4 more
europepmc   +1 more source