Results 41 to 50 of about 71,664 (187)

Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)–Positive Metastatic Breast Cancer. A Randomized Clinical Trial [PDF]

, 2017
IMPORTANCE Treatment with the anti-ERBB2 humanized monoclonal antibody trastuzumab and chemotherapy significantly improves outcome in patients with ERBB2 (HER2)–positive metastatic breast cancer; a clinically effective biosimilar may help increase ...
Herson, Jay, Waller, Cornelius F., Baramidze, Kakhaber, Sriuranpong, Virote, Kothekar, Mudgal, Barve, Abhijit, Manikhas, Alexey, Ruiz, Eduardo P Yanez, Hernandez-Bronchud, Miguel, Sharma, Rajiv, Mukhametshina, Guzel, Loganathan, Subramanian, Pennella, Eduardo, Rugo, Hope S., Vynnychenko, Ihor, Nemsadze, Gia, Ray, Sirshendu, Abesamis Tiambeng, Maria Luisa T., Bondarenko, Igor, Parra, Joseph D, Mamillapalli, Gopichand, Yuan, Jinyu, Baczkowski, Mark, Akewanlop, Charuwan   +23 more
core   +2 more sources

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

British Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló, Attila Imre, Gábor Varga, Sándor Kovács, György Tímár, Balázs Nagy   +5 more
wiley   +1 more source

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

Micro‐ and nanoplastics in gastrointestinal disorders: Mapping the translational gap between exposure, biomonitoring, and pathogenic mechanisms

BMEMat, EarlyView.
This review highlights critical “translational gaps” in understanding micro‐ and nanoplastics impacts on gastrointestinal diseases, bridging exposure, detecting, and mechanistic toxicology. Abstract Micro‐ and nanoplastics (MNPs) have become pervasive environmental contaminants with increasing evidence linking them to adverse health outcomes.
Zhenli Diao, Yujie Luo, Chuanda Zhu, Yanwei Hu   +3 more
wiley   +1 more source

C‐Terminal Functionalization Methods of Amino Acids, Peptides, and Proteins

Chemistry – A European Journal, EarlyView.
C‐terminal functionalization offers powerful routes to peptide and protein diversification, yet epimerization, hydrolysis, and selectivity remain key challenges. This Review surveys enzymatic, decarboxylative, and condensation strategies, highlighting advances toward chemo‐ and regioselective, protecting‐group‐free, atom‐efficient methods applicable to
Jay Hanssens, Mark Lambers, Romano V. A. Orru, Jordy M. Saya   +3 more
wiley   +1 more source

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

Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments—A VigiBase Disproportionality Analysis Study

Clinical Pharmacology &Therapeutics, EarlyView.
Pregnancy‐associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal–fetal safety of systemic anticancer therapies is critical. We performed a case/non‐case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal–fetal outcomes associated with breast cancer (BC ...
Rayan Kabirian, Floriane Jochum, Elise Dumas, Florence Coussy, Kevin Bihan, Bénédicte Lebrun‐Vignes, Barbara Pistilli, Marc‐Antoine Benderra, Lise Selleret, Laurent Chouchana, Fabien Reyal, Anne‐Sophie Hamy, Paul Gougis   +12 more
wiley   +1 more source

HPR35 The Impact of Biosimilar Trastuzumab on Drug Spending in Australia

, 2022
Objectives Breast cancer is the most common cancer affecting women in Australia with an estimated 20,000 cases diagnosed in 2021. Trastuzumab is the used for the treatment of HER-2 positive breast cancer.
Kim, H, H Kim, S Goodall, D Liew, Liew, D, Goodall, S   +5 more
core   +1 more source

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting

Clinical Pharmacology &Therapeutics, EarlyView.
Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, but the extent to which these suffixes have been incorporated into ...
Danijela Stojanovic, Lisa Wolf, M. Stacey Ricci, Monica A. Muñoz   +3 more
wiley   +1 more source

Dapagliflozin alleviates high‐fat‐induced obesity cardiomyopathy by inhibiting ferroptosis

ESC Heart Failure, Volume 12, Issue 2, Page 1358-1373, April 2025.
Abstract Aim: Dapagliflozin (Dapa) is a novel hypoglycaemic agent with multiple cardiovascular protective effects, and it is widely used in treatment of heart failure patients, but whether it can improve obese phenotype of heart failure and its mechanism is still unclear.
Di Chen, Jiahao Shi, Yue Wu, Lizhu Miao, Zilin Wang, Yixuan Wang, Siwei Xu, Yu Lou   +7 more
wiley   +1 more source