Results 101 to 110 of about 26,695,458 (198)

Highlighting best practices to advance next-generation risk assessment of cosmetic ingredients

NAM Journal
Public expectations and regulatory demands have driven a paradigm shift in cosmetic ingredient safety assessment. Next-generation risk assessment (NGRA) and new approach methodologies (NAMs) provide an opportunity to implement alternative procedures ...
Eric Vaillancourt, Alaa Afdal Mohamed, Jay Ansell, Takao Ashikaga, Ahmed Ayad, Hadeel Ayman, Marize Valadares Campos, Han-Sheng Chien, Arianna Giusti, Masato Hatao, Frances Hill, Abeer Khattab, Reinhard Kreiling, Ah Young Lee, Miao Li, Pinpin Lin, Yen-Chun Lin, Victor Mencarelli, Stanley Milstein, Beta P. Montemayor, Carolina Motter Catarino, Rawda Negm, Gladys Ouédraogo, Eun Jae Park, Mustafa Varçin, Tzu-Yi Yang, Yu Janet Zang, Matthew Philip Dent   +27 more
doaj   +1 more source

Integrated assessment of rifampicin‐mediated induction of transporters and drug‐metabolizing enzymes in a long‐term human liver tissue chip system

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1368-1378, November 2026.
Rifampicin is a prototypical clinical inducer used in drug–drug interaction (DDI) studies. However, the clinical relevance and predictability of rifampicin‐mediated hepatic transporter induction remain poorly defined. Conventional hepatocyte culture models fail to capture clinically relevant regulation of transporters and drug‐metabolizing enzymes ...
Mattie E. Hartauer, Raeanne M. Lanphier, Shivam Ohri, Jessica Snyder, Jacqueline B. Tiley, John K. Fallon, Henry Ho, Murat Cirit, Shiny Amala Priya Rajan, Kim L. R. Brouwer   +9 more
wiley   +1 more source

Successful Translational Prediction of Bedaquiline's Phase 2a Clinical Trial Results against Tuberculosis: The Zebrafish as a New Approach Methodology

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1281-1286, November 2026.
Tuberculosis remains an urgent global health crisis that requires an accelerated development of novel regimens. Rodent and rabbit studies currently inform early translational predictions. However, the zebrafish (Danio rerio) embryo/larva, as a New Approach Methodology, provides an ethical, cost‐effective, and high‐throughput non‐mammalian disease model
Bart van Lieshout, Aanisah Hanuun, J. G. Coen van Hasselt, Rob C. van Wijk   +3 more
wiley   +1 more source

The maternal-to-zygotic transition is a critical window for PFOA-induced disruption of developmental programming

Frontiers in Cell and Developmental Biology
Early embryogenesis is governed by precisely timed gene regulatory programs that coordinate cell fate specification, tissue patterning, and morphogenesis.
Zainab Afzal, Vandana Veershetty, Evan E. Pittman, Evan E. Pittman, Charles Hatcher, Deepak Kumar, Deepak Kumar   +6 more
doaj   +1 more source

New approaches build upon historical studies in dermal toxicology [PDF]

, 2023
\ua9 2023 Royal Society of Chemistry. All rights reserved.These are my personal reflections on the history of approaches to understanding dermal toxicology brought together for the Paton Prize Award.
Williams FM
core  

Recent advances and current challenges of new approach methodologies in developmental and adult neurotoxicity testing [PDF]

Adult neurotoxicity (ANT) and developmental neurotoxicity (DNT) assessments aim to understand the adverse effects and underlying mechanisms of toxicants on the human nervous system. In recent years, there has been an increasing focus on the so-called new
Midali, Miriam, Stinckens, Marth, Serafini, Melania Maria, Rundén-Pran, Elise, Vanhaecke, Tamara, Sepheri, Sara, Marinovich, Marina, Tanima, SenGupta, Biesiekierska, Marta, Gatzios, Alexandra, Roszak, Joanna, Wolniakowska, Anna, Reszka, Edyta, Viviani, Barbara, Biesiekierska M., Gatzios A., Viviani B., Wolniakowska A., Sepehri S., Vanhaecke T., Midali M., SenGupta T., Roszak J., Stinckens M., Serafini M. M., Sepehri, Sara, Melania Maria Serafini, SenGupta, Tanima, Marinovich M., Reszka E., Runden-Pran E.   +30 more
core   +1 more source

From Prediction to Decision Making: PBPK and QSP as Regulatory‐Grade NAMs

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1195-1207, November 2026.
New approach methodologies (NAMs) encompass a diverse and rapidly evolving set of experimental and computational tools designed to generate human‐relevant mechanistic data for use in drug development and regulatory decision making. Experimental NAMs provide insights into drug disposition, pharmacological activity, and disease biology that are difficult
Karen Rowland Yeo, Piet H. van der Graaf
wiley   +1 more source

Empirical PK/PD Model for Differentiating Intrinsic Dosing Rules by Therapeutic Indication With Relevance for HIV‐1 Latency Reversal

Clinical Pharmacology &Therapeutics, Volume 120, Issue 5, Page 1414-1426, November 2026.
Romidepsin (RMD), an FDA‐approved histone deacetylase inhibitor for treating cancer, demonstrates potent latency‐reversing activity in vitro but has yielded suboptimal outcomes in kick‐and‐kill HIV‐cure trials when administered as a 5 mg/m2 infusion.
Lauren A. R. Tompkins, Amanda Poliseno, Airlie Ward, Edward P. Browne, Cassandra Gilbert, Craig Sykes, Angela D. M. Kashuba, Mackenzie L. Cottrell   +7 more
wiley   +1 more source

Exploring Alternatives to Animal Testing: Scientific, Legal and Ethical Challenges in Developing Novel Alternative Methods with a Focus on Organoids as Potential NAMs

Journal of Animal Law, Ethics and One Health
Organoids are multicellular, three-dimensional structures derived from stem cells. They require an extracellular matrix and are capable of recapitulating cell types, organ structure, and organ function.
Inesa Fausch, Daniel Zeyer-Iyengar, Rosa Maria Cajiga Morales , Bernice Elger, Volker Enzmann, Alfred Früh   +5 more
doaj   +1 more source

Target‐Engagement Prediction From Molecular Structure, In Vitro and Animal Data: A Tutorial for Early Assessment of Clinical Drug Exposure and Therapeutic/Adverse Potential Using the ANDROMEDA and PLATO Software on the InSilicoTrials Platform

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 11, November 2026.
ABSTRACT The target‐engagement predictor, implemented within the InSilicoTrials cloud‐based, AI‐powered platform for model‐informed drug discovery and development, enables early exploration of time‐dependent pharmacological responses. Predictions can be generated using inputs ranging from molecular structure to in vitro, animal, and clinical data ...
Niccolò Totis, Fianne Sips, Simona Catozzi, Marc‐Antonio Bisotti, Pauline Bambury, Sofia Stathopoulos, Vincenzo Carbone, Luca Emili, Mario Torchia, Valentina Belgiovine, Fulvio Ciriaco, Orazio Nicolotti, Urban Fagerholm, Candice N. Baker, J. Matthew Mahoney, Daniel Röshammar, on behalf of the CARDIOVERSE Project   +16 more
wiley   +1 more source