11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation

Global CRO Council in Bioanalysis, Islam, R., Briscoe, C., Bower, J., Cape, S., Arnold, M., Hayes, R., Warren, M., Karnik, S., Stouffer, B., Xiao, Y. Q., van der Strate, B., Sikkema, D., Fang, X., Tudoroniu, A., Tayyem, R., Brant, A., Spriggs, F., Barry, C., Khan, M., & 31 othersKeyhani, A., Zimmer, J., Caturla, M. C., Couerbe, P., Khadang, A., Bourdage, J., Datin, J., Zemo, J., Hughes, N., Fatmi, S., Sheldon, C., Fountain, S., Satterwhite, C., Colletti, K., Vija, J., Yu, M., Stamatopoulos, J., Lin, J., Wilfahrt, J., Dinan, A., Ohorodnik, S., Hulse, J., Patel, V., Garofolo, W., Savoie, N., Brown, M., Papac, D., Buonarati, M., Hristopoulos, G., Beaver, C. & Boudreau, N., Apr-2018, In: Bioanalysis. 10, 7, p. 433-444 12 p.

Research output: Contribution to journal › Editorial › Academic › peer-review

EBF recommendation on practical management of critical reagents for PK ligand-binding assays

Pihl, S., van der Strate, B. W. A., Golob, M., Vermet, L., Jaitner, B., Goodman, J., Fjording, M. S. & Timmerman, P., Oct-2018, In: Bioanalysis. 10, 19, p. 1557-1566 10 p.

Research output: Contribution to journal › Article › Academic › peer-review

Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum

Kall, M. A., Michi, M., van der Strate, B., Freisleben, A., Stoellner, D. & Timmerman, P., Nov-2018, In: Bioanalysis. 10, 21, p. 1723-1732 10 p.

Research output: Contribution to journal › Editorial › Academic › peer-review

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3-LBA: immunogenicity, biomarkers and PK assays)

Gupta, S., Richards, S., Amaravadi, L., Piccoli, S., Desilva, B., Pillutla, R., Stevenson, L., Mehta, D., Carrasco-Triguero, M., Neely, R., Partridge, M., Staack, R. F., Zhao, X., Gorovits, B., Kolaitis, G., Sumner, G., Stubenrauch, K-G., Zou, L., Amur, S., Beaver, C., & 47 othersBerger, I., Berisha, F., Birnboeck, H., Bower, J., Cho, S., Cludts, I., Cocea, L., Di Donato, L., Fischer, S., Fraser, S., Garofolo, F., Haidar, S., Haulenbeek, J., Hottenstein, C., Hu, J., Ishii-Watabe, A., Islam, R., Jani, D., Kadavil, J., Kamerud, J., Kramer, D., Kurki, P., MacMannis, S., McNally, J., Mullan, A., Papadimitriou, A., Pedras-Vasconcelos, J., Ray, S., Safavi, A., Saito, Y., Savoie, N., Fjording, M. S., Scheibner, K., Smeraglia, J., Song, A., Stouffer, B., Tampal, N., van der Strate, B., Verch, T., Welink, J., Xu, Y., Yang, T., Yengi, L., Zeng, J., Zhang, Y., Zhang, Y. & Zoog, S., Dec-2017, In: Bioanalysis. 9, 24, p. 1967-1996 30 p.

Research output: Contribution to journal › Article › Academic › peer-review