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SaveShare Save Share Save HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions
Bercu, Joel; Trejo-Martin, Alejandra; Chen, Connie; Schuler, Maik; Cheung, Jennifer; Cheairs, Tetyana; Lynch, Anthony M.; Thomas, Dean; Czich, Andreas; Atrakchi, Aisar; Mcgovern, Timothy J.; Heflich, Robert H.; Vespa, Alisa; Froetschl, Roland; Yang, Yi; Gandhi, Raj D.; Elloway, Joanne; Ziegler, Verena; Hellmann, Anna; Schaefer, Michelle; Tennant, Rachael E.; Westerink, Walter; Hoffmans, Roy; Jolly, Robert; Noteboom, Jessica; Gollapudi, Pavan; Sobol, Zhanna; Mcgettigan, Katherine K.; Christensen, Joel S.; Simon, Stephanie; Dieckhoff, Jessica; Zeller, Andreas; Marchand, Christine; Waese, Kerstin; Bishop, Michelle E.; Leavitt, Penny; Hargreaves, Victoria; Glick, Connor; Liao, Yang; Elespuru, Rosalie; Puglisi, Raechel Share Save Fragmentation of recombinant human interleukin-12 by matriptase in CHO cell cultureAapjeet, Fnu; Tang, Tiffany; Zhang, Yixiao; Gopalan, Aditya; Kallappagoudar, Satish; Pan, Jessica; Ma, Fengfei; Shah, Sunil S.; Rivera, Shannon; Liu, Anita Ping-wen; Juan, Veronica; Liu, Ren Share Save Share Save Share Save A pharmaceutical industry survey results on the cycle time, drivers and enablers, for key deliverables in the early phase of drug product development from dose limiting toxicity to first subject first dose: The survey conducted by the IQ cycle time benchmarking working groupCampbell, Gossett A.; Barrett, Stephanie E.; Thakral, Seema; Lowinger, Michael; Faassen, Fried; Vander Kamp, Kirk A.; Wagner, Daniel; Bargmann-Leyder, Nathalie; Badawy, Sherif; Gaebele, Tracy; Snyder, Phillip Share Save Share Save Using Model Master Files to Support Oral Drug Product Development and Regulatory SubmissionsCheng, Yi-Hsien; Pal, Arindom; Moody, Rebecca; Heimbach, Tycho; Lukacova, Viera; Patel, Nikunjkumar; Rullo, Gregory; Xu, Yunming; Ahmed, Tausif; Kerwash, Essam; Fang, Lanyan; Wu, Fang Share Save The Pistoia Alliance's methods database project: Instrument, chromatographic data system, and vendor-agnostic digital transfer of machine-readable high-performance liquid chromatography-ultraviolet methods using the allotrope data formatAggarwal, Pankaj; Dabo, Azzedine; Sun, Cheng; Antonucci, Vincent; Colsman, Wolfgang; Fessenmayr, Heiko; Wells, Kenneth M.; Mccomas, Juliet; Noelken, Gerhard; Nielsen, Birthe, V Share Save Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in MedicinesDirat, Olivier; Urquhart, Michael W.; Akehurst, Heather; Burns, Michael J.; Dobo, Krista L.; Harvey, James; Kuhl, Nadine; Schlingemann, Joerg; Tomlin, Paula; Wetter, Christian Share Save Share Save Bayesian hierarchical model predicts biopharmaceutical stability indicators and shelf life with application to multivalent human papillomavirus vaccineFerrari, Federico; Berger, Jordan; Lemieux, Linda; Paduraru, Crina; Dillon, Michael; Liaw, Andy; Carrillo, Ralf; Wong, Sally; Salami, Hossein; Avalle, Paolo; Sherer, Edward; Richardson, Douglas; Skomski, Daniel Share Save Ex vivo and in vivo HIV-1 latency reversal by Mukungulu, a protein kinase C-activating African medicinal plant extractRichard, Khumoekae; Yuan, Zhe; Tang, Hsin-Yao; Goldman, Aaron R.; Kuthu, Riza; Raphane, Boingotlo; Register, Emery T.; Sharma, Paridhima; Ross, Brian N.; Morris, Jessicamarie; Williams, David E.; Cheney, Carol; Wu, Guoxin; Mounzer, Karam; Laird, Gregory M.; Zuck, Paul; Andersen, Raymond J.; Simonambango, Sundana; Andrae-Marobela, Kerstin; Tietjen, Ian; Montaner, Luis J. Share Save Share Save Share Save Share Save Phase 2 trial of imprime and pembrolizumab immunotherapy in metastatic triple negative breast cancer patients who have progressed beyond first line chemotherapyStopeck, Alison T.; Abu-Khalaf, Maysa; Borges, Virginia; Chmielowski, Bartosz; Rao, Ruta; Xie, Bin; Dudek, Arkadiusz Z.; Mina, Lida; O'Shaughnessy, Joyce; Chisamore, Michael; Mattson, Paulette; Gargano, Michele; Cox, Joanna; Osterwalder, Bruno; Drees, Jeremy; Harrison, Ben; Chan, Anissa S. H.; Qiu, Xiaohong; Ottoson, Nadine; Bose, Nandita; Uhlik, Mark; Graff, Jeremy; Iglesias, Jose Share Save Utilizing non-clonal CHO cell derived materials for preclinical studies of complex moleculesPan, Jessica; Mcphee, Jeffrey; Dow, Alex; Burke, Daniel; Gupta, Balrina; Rose, Patricia; Wang, Xiaowen; Pinto, Nuno; Letarte, Simon; Huang, Ying; Li, Guanghua Benson; Agarwal, Kitty; Smith, Katelyn; Liu, Ren Share Save 
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