未登录Beyond contracts: principles for Pharma-CRO collaboration from the European Bioanalysis Forum超越合同：欧洲生物分析论坛关于制药企业与合同研究组织合作的原则
Timmerman, Philip; Barfield, Matthew; Goodwin, Lee; Love, Iain; Cowan, Kyra; Anderson, Lene; Gaertner, Fabian; Golob, Michaela; Nelson, Robert; Knutsson, Magnus .png)
分享.png)
收藏European Bioanalysis Forum recommendation on embracing a context-of-use-driven scientific validation for chromatographic assays in the light of ICH M10欧洲生物分析论坛关于在ICH M10框架下，采用基于使用场景驱动的科学验证方法对色谱分析法进行验证的建议。Timmerman, Philip; McDougall, Stuart; Adcock, Neil; Arfvidsson, Cecilia; Barfield, Matthew; Blech, Stefan; Cowan, Kyra J.; Ferrari, Luca; Greco, Alessandro; Golob, Michaela; Goodwin, Lee; Hughes, Richard; Ivanova, Tsvetelina; Lauren, Anna; Nelson, Robert; Neitzel, Sonja; Verhaeghe, Tom; van de Merbel, Nico; Wright, Mike; White, Stephen 分享 收藏 Neutralizing Antibody Sample Testing and Report Harmonization (vol 26, 80, 2024)Jani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; Delcarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏 Neutralizing Antibody Sample Testing and Report HarmonizationJani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; DelCarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏 Immunogenicity of avelumab in patients with metastatic Merkel cell carcinoma or advanced urothelial carcinomaHu, Ping; Dai, Haiqing Isaac; Bourdage, James; Zhou, Dongli; Trang, Ky; Kowalski, Karey; Bello, Carlo; Hibma, Jennifer; Khandelwal, Akash; Cowan, Kyra; Dong, Jennifer; Venkatakrishnan, Karthik; Gao, Wei 分享 收藏 分享 收藏 分享 收藏 分享 收藏 分享 收藏 R399E, A Mutated Form of Growth and Differentiation Factor 5, for Disease Modification of OsteoarthritisGigout, Anne; Werkmann, Daniela; Menges, Stephanie; Brenneis, Christian; Henson, Frances; Cowan, Kyra J.; Musil, Djordje; Thudium, Christian S.; Guehring, Hans; Michaelis, Martin; Kleinschmidt-Doerr, Kerstin 分享 收藏 Anti-drug Antibody Sample Testing and Reporting HarmonizationJani, Darshana; Marsden, Robin; Gunsior, Michele; Hay, Laura Schild; Ward, Bethany; Cowan, Kyra J.; Azadeh, Mitra; Barker, Breann; Cao, Liching; Closson, Kristin R.; Coble, Kelly; Dholakiya, Sanjay L.; Dusseault, Julie; Hays, Amanda; Herl, Carina; Hodsdon, Michael E.; Irvin, Susan C.; Kirshner, Susan; Kolaitis, Gerry; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lipari, Francesco; Liu, Susana; Merdek, Keith D.; Moldovan, Ioana R.; Mozaffari, Reza; Pan, Luying; Place, Corina; Snoeck, Veerle; Manning, Marta Starcevic; Stocker, Dennis; Tary-Lehmann, Magdalena; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Williams, William T.; Yan, Haoheng; Yan, Weili; Yang, Lili; Yang, Lin; Zemo, Jennifer; Zhong, Zhandong Don 分享 收藏 分享 收藏 Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator MaterialCowan, Kyra J.; Amaravadi, Lakshmi; Cameron, Mark J.; Fink, Damien; Jani, Darshana; Kamat, Medha; King, Lindsay; Neely, Robert J.; Ni, Yan; Rhyne, Paul; Riffon, Renee; Zhu, Yuda 分享 收藏 分享 收藏 Impact of SPR biosensor assay configuration on antibody: Neonatal Fc receptor binding dataWang, Xiangdan; McKay, Patrick; Yee, Liliana T.; Dutina, George; Hass, Philip E.; Nijem, Ihsan; Allison, David; Cowan, Kyra J.; Lin, Kevin; Quarmby, Valerie; Yang, Jihong 分享 收藏 Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor免疫检查点抑制剂anti-PD-L1单克隆抗体的临床前药代动力学，药效学，组织分布和肿瘤渗透性Deng, Rong; Bumbaca, Daniela; Pastuskovas, Cinthia V.; Boswell, C. Andrew; West, David; Cowan, Kyra J.; Chiu, Henry; McBride, Jacqueline; Johnson, Clarissa; Xin, Yan; Koeppen, Hartmut; Leabman, Maya; Iyer, Suhasini 分享 收藏 Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug DevelopmentJani, Darshana; Allinson, John; Berisha, Flora; Cowan, Kyra J.; Devanarayan, Viswanath; Gleason, Carol; Jeromin, Andreas; Keller, Steve; Khan, Masood U.; Nowatzke, Bill; Rhyne, Paul; Stephen, Laurie 分享 收藏 Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administrationZheng, Yanan; Tesar, Devin B.; Benincosa, Lisa; Birnboeck, Herbert; Boswell, C. Andrew; Bumbaca, Daniela; Cowan, Kyra J.; Danilenko, Dimitry M.; Daugherty, Ann L.; Fielder, Paul J.; Grimm, Hans Peter; Joshi, Amita; Justies, Nicole; Kolaitis, Gerry; Lewin-Koh, Nicholas; Li, Jing; McVay, Sami; O'Mahony, Jennifer; Otteneder, Michael; Pantze, Michael; Putnam, Wendy S.; Qiu, Zhihua J.; Ruppel, Jane; Singer, Thomas; Stauch, Oliver; Theil, Frank-Peter; Visich, Jennifer; Yang, Jihong; Ying, Yong; Khawli, Leslie A.; Richter, Wolfgang F. 分享 收藏 分享 收藏 分享 收藏 
.png){kind=icon}
.png){kind=icon}
.png){kind=icon}
.png){kind=icon}
