Results 141 to 150 of about 14,665 (304)

A White Paper on Advancing Long‐Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation

Clinical Pharmacology &Therapeutics, EarlyView.
As use cases for long‐acting therapeutics expand across clinical indications, there is a critical need to ensure the inclusion of women who are pregnant or breastfeeding, infants and children—populations with a historical gap in the availability of interventions already approved for use in adults.
Moherndran Archary, Robert Bies, Osei Boateng, Rachel Daley, Pierre Gashema, Mili Karina, Emily Njuguna, Sharon Nachman, Nathaniel Nkrumah, Carolyne Odula, Andrew Owen, Ethel D. Weld, Prajith Venkatasubramanian, Adeniyi Olagunju, on behalf of the Community of Practice for Long‐acting Therapeutics for Maternal and Paediatric Health, Rana Abutaima, Dorothy Akongo, Abdulnaser Alsharaa, Moherndran Archary, Shakir Atoyebi, Benoit Bestgen, Robert Bies, Osei Boateng, Andrew Butler, Edmund Capparelli, Rachel Daley, Layla Davies, Joelle Dountio, Henry Enzama, Pierre Gashema, Katila George, Dan Hawcutt, Rene Holm, Patrick Gad Iradukunda, Elodie Jambert, Mili Karina, Linda Lewis, Grace Miheso, Sebastien Morin, Andrew Morrison, Sharon Nachman, Shadia Nakalema, Emily Njunga, Nathaniel Nkrumah, Carolyne Odula‐Obonyo, Brenda Okware, Adeniyi Olagunju, Andrew Owen, Martina Penazzato, Natella Rakhmanina, Mphako Brighton Ratlabyana, Rachel Scott, Kimberly Struble, Andre‐Marie Tchouatieu, Catherine Unsworth, Prajith Venkatasubramanian, Catriona Waitt, Ethel Weld, Janine Winterbottom, Leena Zino   +59 more
wiley   +1 more source

Repurposing Registries: Completeness of Real‐World Data for Regulatory and HTA Purposes in Three Cancer‐Focused Registries

Clinical Pharmacology &Therapeutics, EarlyView.
Despite developments in supporting the identification and selection of fit‐for‐purpose registries, a translational gap remains between the original purposes of clinically focused registries and their current and future expected use in policymaking. This study aimed to assess the extent to which cancer‐focused registries collect essential data elements ...
Manon C. Wilpshaar, Doranne Hilarius, Luisa Prada, Ansgar Weltermann, Christine Leopold   +4 more
wiley   +1 more source

aphp-datascience/study-information-redundancy-rwd-distant-supervision: v1.0.0 [PDF]

<p>Accepted version at LREC-COLING 2024</p ...
Ariel Cohen
core   +1 more source

Recent Regulatory Submissions Using RWD in Oncology

Download full issue of the newsletter here: DOI: 10.5281/zenodo.109098361.
He, Philip, Fernandes, Laura
openaire   +1 more source

External Control Arms in Japan: A Systematic Case Analysis of Documented Regulatory Implementation and Uncertainty Management

Clinical Pharmacology &Therapeutics, EarlyView.
External control arms (ECAs) have emerged as important tools to provide benchmark evidence on comparator effectiveness and thereby support regulatory decision making in situations where randomized controlled trials are difficult to conduct. However, how key methodological elements for ECAs are documented and implemented in practice and how residual ...
Suguru Okami, Alexandros Sagkriotis
wiley   +1 more source

Risk of Bias Associated with Varying Sampling Strategies for External Comparator Cohorts for Single‐Arm Trials: Insights from Aggressive Lymphoma

Clinical Pharmacology &Therapeutics, EarlyView.
Marketing authorizations for oncology drugs are often based on single‐arm trials (SATs), and real‐world data‐based external comparator cohorts (ECCs) are increasingly explored to contextualize results. In retrospective studies, comparators may be identified by time of diagnosis but included based on time of relapse; such sampling strategies can ...
Mikkel Runason Simonsen, Shiva Leisner, Ahmed Ludvigsen Al‐Mashhadi, Laurids Østergaard Poulsen, Matthew Maurer, Lasse Hjort Jakobsen, Tarec Christoffer El‐Galaly   +6 more
wiley   +1 more source

Paroxysmal slow waves mark ictal networks

Epilepsia, EarlyView.
Abstract Objective Epilepsy diagnosis and treatment monitoring are hindered by the episodic, heterogeneous expression of seizures and by normal‐appearing scalp electroencephalography (EEG) in many patients. We previously described paroxysmal slow‐wave events (PSWEs), brief epochs of broadband slowing detectable on EEG in people with epilepsy.
Florent J. M. Boyer‐Aymé, Hamza Imtiaz, Ofer Prager, Evyatar Swissa, Alaa Abu Ahmad, Yonatan Serlin, Refat Aboghazleh, Ilan Goldberg, Maayan Ben nun Caller, Idit Tamir, Oded Shor, Ben Whatley, Felix Benninger, Alon Friedman   +13 more
wiley   +1 more source

Effect of Refractance Window™ and oven drying on physicochemical and sensory properties of peach (Prunus persica L.) surplus

Frontiers in Nutrition
Currently, approximately 34% of fruit is lost and wasted in emerging economies due to inefficient post-harvest processes, technological shortcomings, lesser valorization of surpluses, and byproducts.
Esteban Largo-Avila, Fabián Rico-Rodríguez, Jeanine Kathleen Peñaloza-Figueroa, Alexis López-Padilla   +3 more
doaj   +1 more source

Anterior cingulate cortex neuron subtypes differentially regulate seizures

Epilepsia, EarlyView.
Abstract Objective This study aimed to investigate the regulatory roles of distinct neuronal subtypes within the anterior cingulate cortex (ACC) in acute seizures and to identify cell type‐specific mechanisms underlying seizure modulation in this region. Methods Acute seizure models were established in mice via pentylenetetrazol injection.
Ziqian Yan, Ting Tang, Kaishan Wang, Bin Fu, Zesheng Li, Mingshan Liu, Hongyi Huang, Yanfeng Yang, Qiang Zheng, Yangmin Zheng, Yongzhi Shan, Yumin Luo, Guoguang Zhao   +12 more
wiley   +1 more source

Real World Data (Rwd) At T=4 in the Netherlands [PDF]

Value in Health, 2014
Lie, X., Nijhuis, T.
openaire   +2 more sources