Results 21 to 30 of about 26,695,458 (198)

State of the industry: integration of 3Rs principles and new approach methodologies in non-clinical product development through fit-for-purpose [PDF]

Frontiers in Medicine
Regulators, such as the FDA and EMA, are increasingly signaling expectations for broader and earlier adoption of New Approach Methodologies (NAMs) to reduce, refine, and, where justified, replace animal studies (3Rs principle)—particularly where NAMs can
Sabine M. Poppenborg, Debra Aub Webster, Björn Carlsson   +2 more
doaj   +2 more sources

Impact of the FDA roadmap and perspectives for regulatory use of new approach methodologies in Japanese pharmaceutical companies [PDF]

NAM Journal
Pharmaceutical scientists develop and apply increasingly complex technologies from an expanding toolbox to create more effective and safer drugs.
Tetsuro Araki, Hitoshi Naraoka, Yuta Asakawa, Toru Usui, Dai Kakiuchi, Seiichiro Kurashige, Tadahiro Shinozawa, Kimika Nakamura, Takumi Noda, Satomi Nishikawa, Mutsumi Suzuki   +10 more
doaj   +2 more sources

Technical framework for enabling high quality measurements in new approach methodologies (NAMs). [PDF]

ALTEX, 2023
New approach methodologies (NAMs) are in vitro, in chemico, and in silico or computational approaches that can potentially be used to reduce animal testing. For NAMs that require laboratory experiments, it is critical that they provide consistent and reliable results.
Petersen EJ, Elliott JT, Gordon J, Kleinstreuer NC, Reinke E, Roesslein M, Toman B.   +6 more
europepmc   +3 more sources

Are New Approach Methodologies (NAMs) the Holy Grail of toxicology? [PDF]

Toxicol Sci
Abstract New Approach Methodologies (NAMs), including organoids, microphysiological systems, and computer modeling, are gaining increased popularity for toxicological testing and even mechanistic research. With the use of human cells, the primary objectives of NAMs are to develop more human-relevant test systems and to reduce, and ...
Jaeschke H, Ramachandran A.
europepmc   +3 more sources

New approach methodologies in human regulatory toxicology – not if, but how and when! [PDF]

, 2023
The predominantly animal-centric approach of chemical safety assessment has increasingly come under pressure. Society is questioning overall performance, sustainability, continued relevance for human health risk assessment and ethics of this system ...
LUCH Andreas, BRAEUNING Albert, HERZLER Matthias, VINKEN Mathieu, HARRILL Joshua A., MICCOLI Andrea, GRAFSTRÖM Roland, THOMAS Russel, LUIJTEN Mirjam, BUSCH Wibke, HARTUNG Thomas, KASS George, MARX-STOELTING Philip, LEIST Marcel, VAN RAVENZWAAY Bennard, KLEINSTREUER Nicole, SCHMEISSER Sebastian, ROTH Adrian, BERGGREN Elisabet, DESAINTES Christian, ROGIERS Vera, GOURMELON Anne, ROGGEBAND Rob, POETZ Oliver, VAN DE WATER Bob, SANDERS Pascal, VINGGAARD Anne Marie, VON BERGEN Martin, TRALAU Tewes   +28 more
core   +4 more sources

Towards human cardiac new approach methodologies (NAMs) to evaluate the combination of repolarization prolonging and shortening drugs: a pilot study [PDF]

Frontiers in Drug Discovery
Ksenia Blinova, Tromondae K Feaster, Carlos Serna III   +2 more
exaly   +2 more sources

Incorporating New Approach Methodologies into Regulatory Nonclinical Pharmaceutical Safety Assessment [PDF]

, 2023
New approach methodologies (NAMs) based on human biology enable the assessment of adverse biological effects of pharmaceuticals and other chemicals. Currently, however, it is unclear how NAMs should be used during drug development to improve human safety
Hutchinson, Isobel, Barrios Silva, Lady V., Owen, Carla, Dubourg, Audrey, Hutter, Victoria, Neuhaus, Winifred, Kenna, J. Gerry, Pound, Pandora, Harries, Lorna W., Turner, Jan, Watkins, Paul B., Coleman, Michael, Rego Alvarez, Laura, Taylor, Kevin, Hop, Marina, Chau, David Y. S., Lauschke, Volker M., Roper, Clive, Welch, Jonathan, Hutchinson, I, Silva, LVB, Coleman, M, Harries, LW, Dubourg, A, Turner, J, Chau, DYS, Owen, C, Pound, P, Hop, M, Jan Turner   +29 more
core   +3 more sources

Editorial: European partnership on the assessment of risks from chemicals (PARC): focus on new approach methodologies (NAMs) in risk assessment [PDF]

Frontiers in Toxicology
Louise Ramhøj, Terje Svingen, Tamara Vanhaecke   +2 more
doaj   +2 more sources

New approach methodologies (NAMs) for the in vitro assessment of cleaning products for respiratory irritation: workshop report. [PDF]

Front Toxicol
The use of in vitro new approach methodologies (NAMs) to assess respiratory irritation depends on several factors, including the specifics of exposure methods and cell/tissue-based test systems. This topic was examined in the context of human health risk
Haber LT, Bradley MA, Buerger AN, Behrsing H, Burla S, Clapp PW, Dotson S, Fisher C, Genco KR, Kruszewski FH, McCullough SD, Page KE, Patel V, Pechacek N, Roper C, Sharma M, Jarabek AM.   +16 more
europepmc   +2 more sources

In Vitro–In Vivo Extrapolation by Physiologically Based Kinetic Modeling: Experience With Three Case Studies and Lessons Learned

Frontiers in Toxicology, 2022
Physiologically based kinetic (PBK) modeling has been increasingly used since the beginning of the 21st century to support dose selection to be used in preclinical and clinical safety studies in the pharmaceutical sector.
Engi Abdelhady Algharably, Emma Di Consiglio, Emanuela Testai, Francesca Pistollato, Hans Mielke, Ursula Gundert-Remy, Ursula Gundert-Remy   +6 more
doaj   +1 more source