Results 201 to 210 of about 72,330 (254)

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

Development and Preliminary Evaluation of iCanPlan: A Mobile Health Application for Intimate Partner Violence Prevention in Thailand. [PDF]

Int J Environ Res Public Health
Chuemchit M, Chernkwanma S, Phyo T, Kantipudi S.   +3 more
europepmc   +1 more source

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source

The Invisible Hand, the Visible Wound, and the Commercial Determinants of Health: Complicity of Commercial Entities and the Palestine Catastrophe. [PDF]

Int J Soc Determinants Health Health Serv
Mofizul Islam M.
europepmc   +1 more source

Safety and pharmacokinetics of mosliciguat, a new, inhaled soluble guanylate cyclase activator, in healthy adult subjects

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Mosliciguat (BAY 1237592), the first soluble guanylate cyclase (sGC) activator in a dry powder inhaler (DPI), could potentially treat pulmonary hypertension with a more targeted delivery than systemic sGC stimulators. We report safety and tolerability of mosliciguat in healthy men.
Johannes Nagelschmitz, Soundos Saleh, Sandra Ligges, Melanie Seidel‐Greven, Eva Becker‐Pelster, Sylvia M. Nikkho, Stefanie Boxnick, Wolfgang Timmer   +7 more
wiley   +1 more source

Institutional challenges in responding to Austria's Dying Decree Law: An evaluation from the perspectives of nursing and medical directors. [PDF]

Palliat Care Soc Pract
Vielgrader TL, Hluch JM, Doppler K, Zeilinger EL, Mewes R, Parrag S, Wochele-Thoma T, Kletecka-Pulker M, Dinges S.   +8 more
europepmc   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Abortion in conflict zones: moral responsibilities of humanitarian agencies in providing safe abortion care. [PDF]

Front Reprod Health
Anokwuru CC, Ekwebene OC, Nwuzoh MI, Edeh GC, Nwalieji CA, Udokang EI, Obi CG, Eneh S.   +7 more
europepmc   +1 more source

Relationships among nitrous oxide exposure, neurological injury and biomarkers

British Journal of Clinical Pharmacology, EarlyView.
Aims Recreational nitrous oxide (N2O) misuse is an increasing public health problem associated with functional cobalamin (B12) deficiency and severe neurological complications. Despite growing recognition of its harms, the dose–response relationship and clinical value of biomarkers remain unclear.
Laxna Bhujel, Angela L. Chiew, Bhashita Jagarlamudi, Pramod Chandru, Naren Gunja, Nancy Briggs, Betty S. Chan   +6 more
wiley   +1 more source

Vocational rehabilitation for people with multiple sclerosis: A systematic scoping review of international evidence. [PDF]

PLoS One
Gualco C, Grange E, Rotondi F, Salivetto M, Pignattelli E, Manacorda T, Grasso MG, Presicce G, Inglese M, Nasone L, Durando P, Dini G, Persechino B, Brichetto G, Ponzio M.   +14 more
europepmc   +1 more source