Results 31 to 40 of about 7,323,481 (90)

Path dependency and the rescuing of the biomedical research enterprise

Frontiers in Medical Technology
In 2025, three U.S. agencies within the Department of Health and Human Services (FDA, NIH, CDC) alongside EPA and the Departments of the Navy and Veterans Affairs, began substituting animal testing applications with reliable, human-relevant methods.
Zaher Nahle, Zaher Nahle
doaj   +1 more source

Cancer pain: current practice and emerging targets

British Journal of Pharmacology, EarlyView.
Cancer pain (CP) arises from a complex interplay between the tumour and its microenvironment. Many patients experience a mixed pain phenotype that encompasses nociceptive, neuropathic and neuroinflammatory mechanisms, and vary across tumour type and disease stage. Despite decades of intensive research, the mainstay of cancer pain treatment is still non‐
Yi Ye, Marcin Chwistek, Zhiting Gong, Vanessa Uzonwanne, Xiaojie Shi, Arpad Szallasi   +5 more
wiley   +1 more source

Integrating New Approach Methodologies (NAMs) into Preclinical Regulatory Evaluation of Oncology Drugs

Biomimetics
Traditional animal-based preclinical models, including xenografts and genetically engineered mice, have been used for assessing pharmacodynamics, toxicity, efficacy, and safety for decades. Despite their limited ability to mimic human tumor heterogeneity,
Maryam Sadat Mirlohi, Tooba Yousefi, Amir Reza Aref, Amir Seyfoori   +3 more
doaj   +1 more source

Human placental transfer of xenobiotics in health and disease: New approach methodologies for developmental and reproductive toxicology testing and mathematical modelling

The Journal of Physiology, EarlyView.
Abstract figure legend New approach methodologies (NAMs) to test the pharmaco‐ and chemicokinetics of compound transfer across the human placental barrier in late pregnancy. Abstract This review addresses an important and timely topic at the intersection of placental biology with respect to barrier transfer kinetics, toxicology and mathematical ...
Paul Brownbill, Eleanor Doman
wiley   +1 more source

Food Safety Modernization Act: The Case for Complementary Public Regulation and Private Standards [PDF]

, 2015
President Obama signed into law the Food and Drug Administration (FDA) Food Safety Modernization Act of 2010 (FSMA) in January 2011. FSMA is a set of regulations that modifies U.S. food safety laws and extends their scope.
Pouliot, Sebastien, Jensen, Helen
core  

Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1250-1254, November 2026.
New Approach Methodologies (NAMs) represent a paradigm shift in drug development and regulatory science, offering human‐relevant alternatives to traditional preclinical models. This mini‐review highlights recent advances in NAM development, validation, and regulatory application from FDA's Division of Applied Regulatory Science (DARS).
Ksenia Blinova, Kimberly Chiu, Anik Chaturbedi, Jahan Cooper, Tromondae K. Feaster, Paula L. Hyland, Lidiya Stavitskaya, Wendy W. Wu, Jeffry Florian, Rodney Rouse   +9 more
wiley   +1 more source

Analytical similarity as the primary determinant of monoclonal antibody development: toward evidence-efficient regulatory frameworks

Frontiers in Drug Delivery
Monoclonal antibodies (mAbs) constitute the most rapidly expanding and therapeutically impactful class of biological medicines, driven by their exceptional target specificity, modular engineering capabilities, predictable pharmacokinetics facilitated by ...
Sarfaraz K. Niazi
doaj   +1 more source

Advancing Regulatory Adoption of New Approach Methodologies

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1178-1180, November 2026.
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has a long history advancing new approach methodologies (NAMs). In collaboration with external organizations and other regulatory agencies, FDA supports continued development of NAMs for regulatory use.
Jeffry Florian, Kimberly Chiu, Rebecca Racz, C. Lee Elmore, Shirley K. Seo, Ksenia Blinova, Wendy W. Wu, Rodney Rouse   +7 more
wiley   +1 more source

Prospects for 3D Bioprinting Research and Transdisciplinary Application to Preclinical Animal Models

Shiyan dongwu yu bijiao yixue
Animal experiments are widely used in biomedical research for safety assessment, toxicological analysis, efficacy evaluation, and mechanism exploration. In recent years, the ethical review system has become more stringent, and awareness of animal welfare
HU Min, DONG Lexuan, GAO Yi, XI Ziqi, SHEN Zihao, TANG Ruiyang, LUAN Xin, TANG Min, ZHANG Weidong   +8 more
doaj   +1 more source

In Silico Clinical Trials in Drug Development: Virtual Patients, Applications, and Regulatory Convergence

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1181-1194, November 2026.
Conventional clinical trials remain the benchmark for evaluating therapeutic safety and efficacy, yet they are constrained by escalating costs, withdrawal over the extended follow‐up periods, recruitment difficulties, ethical limits, and a restricted ability to characterize heterogeneous populations.
Maximilian Balmus, Sheng‐Ya Wang, Edward W. G. Ashton, Rosie K. Barrows, Molly Monks, Yuzhang Ge, Arthur Lefebvre, Steven A. Niederer   +7 more
wiley   +1 more source