Results 81 to 90 of about 108,288 (261)

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

Carrier‐free self‐assembled nanomedicine for combination‐therapy of acute myeloid leukemia

BMEMat, EarlyView.
CPDS combines drugs with three different mechanisms of action to achieve a multi‐mechanism combination therapy for AML by directly killing tumor cells and activating anti‐tumor immunity. Abstract As the main acute myeloid leukemia (AML) clinical treatment, the chemotherapy alone cannot meet the clinical therapeutic needs due to the high heterogeneity ...
Meihong Chai, Rui Zhang, Haiyin Yang, Jiyue Xing, Tianyuan Hu, Mengxi Zhu, Rui Li, Xiaoli Chen, Beibei Zhao, Yang Lan, Stefan Barth, Yuanyu Huang, Li Zhang, Mengjie Zhang, Huining He   +14 more
wiley   +1 more source

Diagnosis and treatment of diffuse large B-cell lymphoma

Swiss Medical Weekly, 2012
Diffuse large B-cell lymphoma (DLBCL) is the most frequently-occurring type of malignant lymphoma in the Western world. It has an aggressive natural history, with a median survival of less than one year if left untreated. Immunochemotherapy regimens, consisting of the anti-CD20 antibody rituximab typically in combination with cyclophosphamide ...
Mey, U, Hitz, F, Lohri, A, Pederiva, S, Taverna, C, Tzankov, A, Meier, O, Yeow, K, Renner, C   +8 more
openaire   +3 more sources

Characterization of Lysosomal Hydrolases and Transporters and Their Age‐Dependent Variability: Relevance to Drug Metabolism and Transport of Small Molecule and Biologic Drugs

Clinical Pharmacology &Therapeutics, EarlyView.
Lysosomes play a key role in the accumulation, catabolism, and transport of endogenous and exogenous metabolites and proteins and are involved in drug metabolism and prodrug activation. However, the protein abundance and interindividual variability of lysosomal drug‐metabolizing enzymes and transporters (DMETs) remain underexplored.
Darshak Gadara, Dilip Kumar Singh, Sandhya Subash, Guihua Yue, Deepak Ahire, Chris Bohl, Maciej Czerwinski, Stephanie Helmstetter, Scott Heyward, Robert S. Jones, Cyrus Khojasteh, Ryota Kikuchi, Priyanka Kulkarni, Bin Ma, Bernard Murray, Chris Seib, Bill Smith, David M. Stresser, Mitchell E. Taub, Ting Wang, Bhagwat Prasad   +20 more
wiley   +1 more source

Payload‐Based Clinical Pharmacology Review of Approved Antibody–Drug Conjugates: Commonalities and Considerations for Streamlined Development

Clinical Pharmacology &Therapeutics, EarlyView.
Antibody–drug conjugates (ADCs) combine the specificity of an antibody with the potency of a cytotoxic drug. Thirteen ADCs, utilizing seven unique cytotoxic payloads and targeting 11 distinct antigens, are currently approved by the US Food and Drug Administration as of June 2025, representing a rapidly growing and highly promising class of anticancer ...
Sijie Lu, Qingqing Xiao, Lixuan Qian, Siyuan Sun, Zhu Zhou, Michael Z. Liao, Chunze Li   +6 more
wiley   +1 more source

Spontaneous resolution of untreated diffuse large B‐cell lymphoma of maxillary bone after incisional biopsy

Clinical Case Reports, 2019
Diffuse large B‐cell lymphoma (DLBCL) is a heterogeneous group of lymphomas which require multiagent therapy for remission induction and are associated with relapse in more than 40% of patients.
Lainey Flatow‐Trujillo, Khine Win, Amy Jencks, Leslie Andritsos, Cecilia Arana Yi   +4 more
doaj   +1 more source

Pan-phosphatidylinositol 3-kinase inhibition with buparlisib in patients with relapsed or refractory non-Hodgkin lymphoma

Haematologica, 2017
Activation of the phosphatidylinositol 3-kinase/mechanistic target of rapamycin pathway plays a role in the pathogenesis of non-Hodgkin lymphoma. This multicenter, open-label phase 2 study evaluated buparlisib (BKM120), a pan-class I phosphatidylinositol
Anas Younes, Gilles Salles, Giovanni Martinelli, Robert Gregory Bociek, Dolores Caballero Barrigon, Eva González Barca, Mehmet Turgut, John Gerecitano, Oliver Kong, Chaitali Babanrao Pisal, Ranjana Tavorath, Won Seog Kim   +11 more
doaj   +1 more source

Model‐Based Analysis with Mechanistic Insights to CAR‐T‐Cell Therapy Kinetics: Case Study with Axicabtagene Ciloleucel and Brexucabtagene Autoleucel

Clinical Pharmacology &Therapeutics, EarlyView.
Model‐informed drug development is increasingly used to support chimeric antigen receptor (CAR)‐T‐cell therapy programs. However, most population pharmacokinetic (PK) CAR‐T‐cell models available in literature are variations of an empirical piecewise‐linear model, which accurately describes the observed data but lacks a mechanistic foundation.
Anna M. Mc Laughlin, Martin Bergstrand, Ana Ruiz‐Garcia, Simone Filosto, Rhine Shen   +4 more
wiley   +1 more source

Correlations between BCL6 rearrangement and outcome in patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP

Haematologica, 2010
Background BCL6 gene rearrangement is the most frequent chromosomal abnormality in diffuse large B-cell lymphoma, a malignancy characterized by genetic heterogeneity and wide variability in clinical outcome.
Jesse Shustik, Guangming Han, Pedro Farinha, Nathalie A. Johnson, Susana Ben Neriah, Joseph M. Connors, Laurie H. Sehn, Douglas E. Horsman, Randy D. Gascoyne, Christian Steidl   +9 more
doaj   +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