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Result harmonization in medical laboratories: accomplishments and challenges Badrick, Tony; Beasley-Green, Ashley; Cobbaert, Christa M.; Delatour, Vincent; Deprez, Liesbet; Jones, Graham R. D.; Josephs, Ralf D.; Kessler, Anja; Liu, Qinde; Maniguet, Stephanie; Miller, W. Greg; Roberts, Glenda V.; Sandberg, Sverre; Van Rossum, Huub H.; Van Uytfanghe, Katleen; Vogl, Christian; Wielgosz, Robert; Zhang, Tianjiao; Panteghini, Mauro Share Save
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A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2 Garcia-Arieta, Alfredo; Tam, Andrew; Tiseyra, Florencia; Fernandes, Eduardo Agostinho Freitas; Soares, Kelen Carine Costa; Pereira, Raphael Sanches; Potthast, Henrike; Mettke, Katalina; Chang, Ya-Wen; Hsu, Li-Feng; Su, Yu-Lin; Martinez, Zulema Rodriguez; Divinsky, Milly; Blake, Kevin; Braddy, April C.; Rodrigues, Clare; Toh, Tiong; Aurela, Erwin Guzman; Gonzalez, Liliana Carolina Arevalo; Jones, Ben; Kim, So Hee; Ahn, Choongyul; Yun, Eunju; Kuribayashi, Ryosuke; Shimojo, Kohei; Kasuga, Miho; Makino, Junya; Raffel, Joel; Van Oudtshoorn, Joy; Tabane, Philda; Alzenaidy, Bader; Alharbi, Mohammed; Alharf, Adel; Binajlan, Albatool; Walther, Chantal; Roost, Matthias S.; Crane, Christopher; Lee, Kitty Share Save
The ReAct project: Analysis of data from 23 different laboratories to characterise DNA recovery given two sets of activity level propositions Gill, Peter; Fonnelop, Ane Elida; Hicks, Tacha; Xenophontos, Stavroulla; Cariolou, Marios; van Oorschot, Roland; Buckel, Iris; Sukser, Viktorija; Papic, Suncica; Merkas, Sinisa; Kostic, Ana; Pereira, Angela Marques; Teutsch, Christina; Forsberg, Christina; Haas, Cordula; Petkovski, Elizabet; Hass, Fabian; Masek, Jan; Stosic, Jelena; Lee, Yong Sheng; Syn, Christopher Kiu-Choong; Groombridge, Linda; Trimborn, Marc; Hadjivassiliou, Marilena; Breathnach, Michelle; Novackova, Jana; Parson, Walther; Hatzer-Grubwieser, Petra; Pietikainen, Sanna; Joas, Simone; Willuweit, Sascha; Grethe, Stefanie; Milicevic, Tamara; Hasselqvist, Therese; Kallupurackal, Venus; Stenzl, Vlastimil; Jansson, Staffan; Glocker, Ingrun; Brunck, Sarah; Nyhagen, Karoline; Lingelem, Anne Berit Dyve; Autere, Heli; Thornbury, Devon; Pedersen, Natalie; Fox, Stephanie; Moore, David; Escott, Gemma; Petersen, Cathrine Bie; Larsen, Hans Jakob; Giles, Rebecca; Allen, Paul Stafford; Prieto, Lourdes; Ramirez, Ester; de Yuso, Isabel Martinez; Bastisch, Ingo Share Save
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Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore Koon, Yen Ling; Lam, Yan Tung; Tan, Hui Xing; Teo, Desmond Hwee Chun; Neo, Jing Wei; Yap, Aaron Jun Yi; Ang, Pei San; Loke, Celine Ping Wei; Tham, Mun Yee; Tan, Siew Har; Soh, Sally Leng Bee; Foo, Belinda Qin Pei; Ling, Zheng Jye; Yip, James Luen Wei; Dorajoo, Sreemanee Raaj Share Save
Promoting Equitable and Affordable Patient Access to Safe and Effective Innovations in Donation and Transplantation of Substances of Human Origin and Derived Therapies Cuende, Natividad; Tullius, Stefan G.; Izeta, Ander; Plattner, Verena; Borgel, Martin; Ciccocioppo, Rachele; Correa-Rocha, Rafael; Koh, Mickey B. C.; De Angelis, Vincenzo; Gondolesi, Gabriel E.; ten Ham, Renske; Porte, Robert J.; Hernandez-Maraver, Dolores; Hawthorne, Wayne J.; Sureda, Anna; Orlando, Giuseppe; Haraldsson, Boerje; Ascher, Nancy L.; Dominguez-Gil, Beatriz; Oniscu, Gabriel C. Share Save
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Extent of Equivalence of Results for Urine Albumin among 3 Candidate Mass Spectrometry Reference Measurement Procedures Miller, W. Greg; Bachmann, Lorin M.; Budd, Jeffrey; Beasley-Green, Ashley; Phinney, Karen W.; Tan, Hwee Tong; Teo, Tang Lin; Liu, Qinde; Shiba, Seiei; Seegmiller, Jesse Share Save
Mechanism of action, potency and efficacy: considerations for cell therapies Simon, Carl G.; Bozenhardt, Erich H.; Celluzzi, Christina M.; Dobnik, David; Grant, Melanie L.; Lakshmipathy, Uma; Nebel, Thiana; Peltier, Linda; Ratcliffe, Anthony; Sherley, James L.; Stacey, Glyn N.; Taghizadeh, Rouzbeh R.; Tan, Eddie H. P.; Vessillier, Sandrine Share Save
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Automated Classification of Quality Defect Issues Relating to Substandard Medicines Using a Hybrid Machine Learning and Rule-Based Approach Teo, Desmond Chun Hwee; Huang, Yiting; Dorajoo, Sreemanee Raaj; Ng, Michelle Sau Yuen; Choong, Chih Tzer; Phuah, Doris Sock Tin; Tan, Dorothy Hooi Myn; Tan, Filina Meixuan; Huang, Huilin; Tan, Maggie Siok Hwee; Koh, Suan Tian; Poh, Jalene Wang Woon; Ang, Pei San Share Save
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Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals Horne, Stephen; Nagavelli, Laxma R.; Sayeed, Vilayat A.; Heckman, Laurel; Johnson, Deborah; Berger, Dan; Yip, Yean Yean; Krahn, Carolina Lopes; Sizukusa, Leticia Oyamada; Rocha, Nayrton Flavio Moura; Ludwig, Joachim; Keire, David A.; Condran, Gary; Vera, Matthew D.; Bream, Robert N. Share Save
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Commutability assessment of human urine certified reference materials for albumin and creatinine on multiple clinical analyzers using different statistical models Liu, Hong; Ng, Cheng Yang; Liu, Qinde; Teo, Tang Lin; Loh, Tze Ping; Wong, Moh Sim; Sethi, Sunil Kumar; Tan, Jun Guan; Heng, Ping Ying; Saw, Sharon; Lam, Leslie Choong-Weng; Lee, Joanne Mee-Yin; Khaled, Khairee Bin; Phyu, Hnin Pwint; Ong, Noel Wan Ting Share Save
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