Results 271 to 280 of about 444,144 (378)

Expedited Approval in Oncology: A Study of European Regulators' Perspectives and Trade‐Offs

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The purpose of this study was to describe the perspectives and trade‐offs of EU regulators about expedited approvals for treatments of patients with advanced cancer. The study consisted of a cross‐sectional survey with assessors and experts from the network of the European Medicines Agency (EMA).
Francesco Pignatti   +5 more
wiley   +1 more source

Alemtuzumab Exposure and T Lymphocyte Depletion: A Population Pharmacokinetic‐Pharmacodynamic Model of Alemtuzumab Induction Therapy for Kidney Transplantation

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Alemtuzumab is a T cell‐depleting monoclonal antibody that is used for the prevention of kidney transplant rejection. The duration of lymphodepletion after the current standard induction therapy dose is likely longer than necessary, resulting in prolonged T cell lymphopenia with the associated risk of infections. Here, the interplay between alemtuzumab
Lukas K. van Vugt   +8 more
wiley   +1 more source

Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real‐World Data Sources for Fit‐for‐Purpose Studies

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The potential of real‐world data (RWD), particularly from patient registries, has been increasingly recognized over the last decade by academia, regulators, and health technology assessment (HTA) bodies for its role in assessing a product's effectiveness and supporting regulatory submissions.
Sonia Zebachi   +13 more
wiley   +1 more source

Pragmatic language production in mood and psychotic disorders a systematic review and meta-analysis

open access: yes
Meister F   +10 more
europepmc   +1 more source

Impact of Hearing Loss Type on Linguistic Development in Children: A Cross-Sectional Study. [PDF]

open access: yesAudiol Res
Porcar-Gozalbo N   +3 more
europepmc   +1 more source

Pharmacogenetic Implementation Studies—Lessons Learned From the PREPARE Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The Ubiquitous Pharmacogenomics consortium (www.upgx.eu) has recently completed and published the Preemptive Pharmacogenomic Testing for Preventing Adverse Drug Reactions (PREPARE) study on the implementation of panel‐based pharmacogenetic testing. PREPARE has provided interesting lessons for the design, execution, and interpretation of future clinical
Henk‐Jan Guchelaar   +37 more
wiley   +1 more source

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