Results 131 to 140 of about 1,288,138 (290)

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

Model‐informed optimal dose selection of golcadomide in combination with R‐CHOP in patients with previously untreated aggressive B‐cell lymphoma

British Journal of Clinical Pharmacology, EarlyView.
Aims Golcadomide is a potential first‐in‐class oral CELMoD™ agent for the treatment of lymphoma. This study aims to develop model‐informed drug development (MIDD) approaches to support optimal dose selection of golcadomide in combination with immunotherapy rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R‐CHOP) in alignment with ...
Xirong Zheng, Zhiling Yu, Mark Kaplan, Argyrios Gkasiamis, Akshay Sudhindra, Li Zhu, Manisha Lamba, Fan Wu   +7 more
wiley   +1 more source

Transfersomes with core and surface‐loaded NF‐κB p65 siRNA for enhanced transdermal transfection and effective treatment of psoriasis

BMEMat, EarlyView.
TCPL, a transfersome with Tween 80 and PEI, enables efficient transdermal siNF‐κB delivery, resolving PEI's toxicity issue. It promotes lysosomal escape and effective transfection, silences NF‐κB, modulates immunity, and inhibits angiogenesis, alleviating psoriasis. With good biocompatibility, TCPL holds strong clinical translation potential. Schematic
Hui Xing, Yuhui Yang, Ziyi Zhao, Kai Lv, Yiran Shao, Zhi Zhang, Dong Ma   +6 more
wiley   +1 more source

Proteomic analysis of human follicular fluid from fertile women

, 2016
Background: Follicular fluid is a unique biological fluid in which the critical events of oocyte and follicular maturation and somatic cell-germ cell communication occur.
Matthew E. Albertolle (3859894), Maria E. Hassis (3859891), Alberuni M. Zamah (7925198), Katherine E. Williams (534332)   +3 more
core  

Bridging the translational gap in clinical nanomedicine: From rational design to clinical reality

BMEMat, EarlyView.
Nanotechnology offers a multi‐faceted approach to modern healthcare, encompassing high‐sensitivity diagnostic imaging, innovative vaccine delivery, and targeted therapeutics. This review explores how these nanomedicine applications address critical challenges in cancer recurrence and the treatment of neurologic and respiratory diseases to combat rising
Ahmed H. Ghonaim, Marwa Ahmed El‐Naka, Wedad M. Nageeb, Atta Ullah Khan, Noura M. Seleem, Aliaa Abdelghafar, Doaa Zamel, Yang Liu, Qigai He, Wentao Li   +9 more
wiley   +1 more source

Innovation of plant‐derived extracellular vesicles and interdisciplinary research: From discovery to biomedical applications

BMEMat, EarlyView.
Plant‐derived extracellular vesicles offer numerous advantages and are regarded as highly promising candidates in the field of biomedicine. Abstract Extracellular vesicles (EVs) are double‐membrane vesicular structures that can be secreted by nearly all living cells.
Zilin Li, Yi Wei, Ben Hu, Yafang Song, Xiaojia Chen, Nik Ahmad Nizam Nik Malek, Tongkai Chen   +6 more
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

Flow cytometry‐based monitoring of chimeric antigen receptor (CAR) T cells: Reagent selection, assay design, and clinical utility

Cytometry Part B: Clinical Cytometry, EarlyView.
Abstract Accurate quantification of chimeric antigen receptor (CAR) T cells is essential for monitoring post‐infusion CART expansion and persistence and for real‐time clinical decision‐making. Multiparameter flow cytometry (MFC) enables rapid, live‐cell detection with absolute quantification and concurrent immunophenotypic characterization. This review
Jianhua Ling, Wei Wang, Sa A. Wang
wiley   +1 more source

Role of SoxE transcription factors in development and disease

Developmental Dynamics, EarlyView.
Abstract Sox8, Sox9, and Sox10 arose by multiple rounds of genome duplications from a single SoxE gene in ancestral vertebrates. In this review, we will briefly discuss the molecular structure and function of SoxE transcription factors and their evolutionary origin. We will then discuss their expression, function, and developmental disorders.
Merin Lawrence, Gerhard Schlosser
wiley   +1 more source

Age, embryo donor status, and insemination with chilled semen all predispose to persistent breeding‐induced endometritis in warmblood mares

Equine Veterinary Journal, EarlyView.
Abstract Background Persistent breeding‐induced endometritis (PBIE) is a common reason for mares failing to establish pregnancy. Objective To examine the hypothesis that advancing mare age and embryo donor status predispose to PBIE and compromise fertility.
Tom Stout, Rik Serrarens, Bart Leemans, Anthony Claes   +3 more
wiley   +1 more source