Results 201 to 210 of about 5,669 (241)

PP374 Topic: AS13–Hematology/Oncology/Stem Cell Transplant/Immunology: PAEDIATRIC INTENSIVE CARE ADMISSIONS POST-HAEMATOPOIETIC STEM CELL TRANSPLANT: WHAT CAN WE LEARN?

open access: bronze
Elisabeth Day   +7 more
openalex   +1 more source

Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology

open access: yesClinical Pharmacology &Therapeutics, Volume 117, Issue 4, Page 1098-1105, April 2025.
In the EU, conditional marketing authorization is a pragmatic tool for early approval of a medicine that fulfills an unmet medical need. In the pharmaceutical legislation, an unmet medical need means that a condition lacks a satisfactory method for diagnosis, prevention, or treatment.
Florian Lasch   +2 more
wiley   +1 more source

Japan's Conditional/Time‐Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets

open access: yesClinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1171-1174, May 2025.
Japan's conditional/time‐limited early approval program, initiated in 2014, aimed to advance regenerative medicine by expediting market access. However, the withdrawal of autologous skeletal myoblast sheets (Heartsheet) due to ineffectiveness raises concerns about the balance between rapid approval and scientific integrity.
Hayase Hakariya   +3 more
wiley   +1 more source

A Half-Century of Heterotopic Heart Transplantation in Mice: The Spearhead of Immunology Research

open access: gold
Decheng Yin   +8 more
openalex   +1 more source

Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real‐World Evidence

open access: yesClinical Pharmacology &Therapeutics, Volume 117, Issue 4, Page 927-937, April 2025.
A compilation of factors over the past decade—including the availability of increasingly large and rich healthcare datasets, advanced technologies to extract unstructured information from health records and digital sources, advancement of principled study design and analytic methods to emulate clinical trials, and frameworks to support transparent ...
Rohini K. Hernandez   +14 more
wiley   +1 more source

Editorial: Immunology of allogeneic hematopoietic stem cell transplantation

open access: diamond
Carmelo Gurnari   +3 more
openalex   +1 more source

Model‐Based Prediction of Clinically Relevant Thrombocytopenia after Allogeneic Hematopoietic Stem Cell Transplantation

open access: yesClinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1413-1426, May 2025.
Platelet reconstitution after allogeneic hematopoietic cell transplantation (allo‐HCT) is heterogeneous and influenced by various patient‐ and transplantation‐related factors, associated with poor prognoses for poor graft function (PGF) and isolated thrombocytopenia.
Katharina M. Götz   +23 more
wiley   +1 more source

Night‐Time Chronotherapy with Methylprednisolone Prevents an Acute Rejection in Pediatric Patients with Liver Transplantation: A Randomized Clinical Trial

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Concept of methylprednisolone chronotherapy to prevent acute rejections. While endogenous cortisol secretion rises in the early morning, the number of lymphocytes in the blood is higher at night, thus exhibiting an antiphase pattern to cortisol secretion. Therefore, compared with the daytime, the infiltration of lymphocytes into immune‐reactive tissues
Kentaro Ushijima   +11 more
wiley   +1 more source

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