Results 81 to 90 of about 170,256 (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

Clinical utility of pembrolizumab in the management of advanced solid tumors: an evidence-based review on the emerging new data

, 2019
Pauline du Rusquec, Ombline de Calbiac, Marie Robert, Mario Campone, Jean Sebastien FrenelMedical Oncology Department, Institut de Cancérologie de l’Ouest, Saint-Herblain 44800, FranceAbstract: Pembrolizumab is a full-length human ...
Campone M, Frenel JS, Robert M, du Rusquec P, de Calbiac O   +4 more
core  

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source

Long-Term Efficacy of Pembrolizumab and the Clinical Utility of ctDNA in Locally Advanced dMMR/MSI-H Solid Tumors

Nature Communications
Neoadjuvant immunotherapy can induce pathologic complete response (pCR) in patients with localized deficient mismatch repair (dMMR)/microsatellite instability-high (MSI-H) tumors.
Michael LaPelusa, Wei Qiao, Bryan Iorgulescu, Francis San Lucas, Keyur Patel, Deepak Bhamidipati, Jane Varkey Thomas, Nancy You, Wai Chin Foo, Dipen Maru, Selvi Thirumurthi, Van Morris, Scott Kopetz, Michael Overman, Kaysia Ludford   +14 more
doaj   +1 more source

Acute Tubulointerstitial Nephritis: A Case Report on Rare Adverse Effect of Pembrolizumab

Medicina, 2019
Pembrolizumab is a novel immune checkpoint inhibitor approved for use in non-small cell lung carcinoma. There have been a few cases that have associated adverse renal outcomes with pembrolizumab.
Sijan Basnet, Rashmi Dhital, Biswaraj Tharu   +2 more
doaj   +1 more source

Safety and efficacy profile of pembrolizumab in solid cancer: pooled reanalysis based on randomized controlled trials

, 2017
Manni Wang,* Xuelei Ma,* Linghong Guo, Fan Xia State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu, People’s Republic of China *These authors contributed equally to this work Background ...
Guo LH, Ma XL, Wang MN, Xia F
core  

From pathogen to “living drug factory” innovative strategies and clinical translation of bacteria as programmable intelligent vectors for cancer therapy

BMEMat, EarlyView.
Engineered bacteria serve as smart, living therapeutics that target tumors, deliver drugs, and remodel immunosuppressive microenvironments. This review highlights their potential to potentiate immunotherapy, radiotherapy, and chemotherapy, offering a promising paradigm for precise and synergistic cancer treatment. Abstract The dynamic interplay between
Haonan Shen, Weichen Zhang, Gaoli Niu, Li Wang, Ruiyan Li, Yueyue Fan, Feixue Lu, Lingling Xu, Xiaoyuan Ji, Yong Kang   +9 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

Effectiveness and safety of pembrolizumab, nivolumab, and atezolizumab as adjuvant therapy for high-risk muscle-invasive urothelial carcinoma: an indirect comparison

Frontiers in Oncology
BackgroundThe effectiveness of immune checkpoint inhibitors (ICIs) as adjuvant therapy for muscle-invasive urothelial carcinoma (MIUC) with high recurrence risk has been demonstrated.
Wei Chen, Wei Chen, Soichiro Yoshida, Noriyoshi Miura, Shohei Fukuda, Hiroshi Fukushima, Yuma Waseda, Hajime Tanaka, Yasuhisa Fujii   +8 more
doaj   +1 more source

Initiation of Gabapentin with Opioids and Risk of Respiratory Cardiovascular and Opioid‐Related Adverse Events Following Surgery for Breast Cancer

Clinical Pharmacology &Therapeutics, EarlyView.
Pain is a key determinant of quality‐of‐life following breast cancer surgery, the most common cancer operation in the United States. Gabapentinoids are frequently prescribed for pain management, yet their respiratory, cardiovascular, and opioid‐related adverse effects remain unclear.
Jyun‐Heng Lai, Anton L V Avanceña, Juan P Cata, Jamie C. Barner, Sharon H. Giordano, Chanhyun Park, Hui Zhao, Kirk E. Evoy, John K. Lin, Jennifer C. Spencer, Mariana Chavez‐MacGregor, Kelly K. Hunt, Kerollos Nashat Wanis   +12 more
wiley   +1 more source