PSTC Participant Publications
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Translational medicine and the value of biomarker qualification
Sci Transl Med. 2010 Sep 1;2(47):47ps44
Goodsaid FM, Mendrick DL.
Molecular biomarkers: a US FDA effort
Biomark Med. 2010 Apr;4(2):215-25
Hong H, Goodsaid F, Shi L, Tong W
Next-generation biomarkers for detecting kidney toxicity
Nat Biotech. 2010. 28, 436-440
Bonventre, J.V., Vaidya, V.S., Schmouder, R., Feig, P. & Dieterle, F.
Nat Biotech. 2010. 28:5, 463-469
Dieterle, F; Perentes, E; Cordier, A; Roth, D R; Verdes, P; Grenet, O; Pantano, S; Moulin, P; Wahl, D; Mahl, A; End, P; Staedtler, F; Legay, F; Carl, K; Laurie, D; Chibout, S D; Vonderscher, J, and Maurer, G.
Nat Biotech. 2010. 28:5, 455-462
Dieterle, F; Sistare, F; Goodsaid, F; Papaluca, M; Ozer, J S; Webb, C P; Baer, W; Senagore, A; Schipper, M J; Vonderscher, J; Sultana, S; Gerhold, D L; Phillips, J A; Maurer, G; Carl, K; Laurie, D; Harpur, E; Sonee, M; Ennulat, D; Holder, D; ndrews-Cleavenger, D; Gu, Y Z; Thompson, K L; Goering, P L; Vidal, J M; Abadie, E; Maciulaitis, R; Jacobson-Kram, D; Defelice, A F; Hausner, E A; Blank, M; Thompson, A; Harlow, P; Throckmorton, D; Xiao, S; Xu, N; Taylor, W; Vamvakas, S; Flamion, B; Lima, B S; Kasper, P; Pasanen, M; Prasad, K; Troth, S; Bounous, D; Robinson-Gravatt, D; Betton, G; Davis, M A; Akunda, J; McDuffie, J E; Suter, L; Obert, L; Guffroy, M; Pinches, M; Jayadev, S; Blomme, E A; Beushausen, S A; Barlow, V G; Collins, N; Waring, J; Honor, D; Snook, S; Lee, J; Rossi, P; Walker, E, and Mattes, W.
Evolution of biomarker qualification at the health authorities
Nat Biotech. 2010. 28:5, 441-443
Goodsaid, F and Papaluca, M.
Research at the interface of industry, academia and regulatory science
Nat Biotech. 2010. 28:5, 432-433
Mattes, W B; Walker, E G; Abadie, E; Sistare, F D; Vonderscher, J; Woodcock, J, and Woosley, R L.
Nat Biotech. 2010. 28:5, 486-494
Ozer, J S; Dieterle, F; Troth, S; Perentes, E; Cordier, A; Verdes, P; Staedtler, F; Mahl, A; Grenet, O; Roth, D R; Wahl, D; Legay, F; Holder, D; Erdos, Z; Vlasakova, K; Jin, H; Yu, Y; Muniappa, N; Forest, T; Clouse, H K; Reynolds, S; Bailey, W J; Thudium, D T; Topper, M J; Skopek, T R; Sina, J F; Glaab, W E; Vonderscher, J; Maurer, G; Chibout, S D; Sistare, F D, and Gerhold, D L
Towards consensus practices to qualify safety biomarkers for use in early drug development
Nat Biotech. 2010. 28:5, 446-454
Sistare, F D; Dieterle, F; Troth, S; Holder, D J; Gerhold, D; ndrews-Cleavenger, D; Baer, W; Betton, G; Bounous, D; Carl, K; Collins, N; Goering, P; Goodsaid, F; Gu, Y Z; Guilpin, V; Harpur, E; Hassan, A; Jacobson-Kram, D; Kasper, P; Laurie, D; Lima, B S; Maciulaitis, R; Mattes, W; Maurer, G; Obert, L A; Ozer, J; Papaluca-Amati, M; Phillips, J A; Pinches, M; Schipper, M J; Thompson, K L; Vamvakas, S; Vidal, J M; Vonderscher, J; Walker, E; Webb, C, and Yu, Y.
Nat Biotech. 2010. 28:5, 478-485
Vaidya, V S; Ozer, J S; Dieterle, F; Collings, F B; Ramirez, V; Troth, S; Muniappa, N; Thudium, D; Gerhold, D; Holder, D J; Bobadilla, N A; Marrer, E; Perentes, E; Cordier, A; Vonderscher, J; Maurer, G; Goering, P L; Sistare, F D, and Bonventre, J V.
Urinary biomarkers trefoil factor 3 and albumin enable early detection of kidney tubular injury
Nat Biotech. 2010. 28:5, 470-477
Yu, Y; Jin, H; Holder, D; Ozer, J S; Villarreal, S; Shughrue, P; Shi, S; Figueroa, D J; Clouse, H; Su, M; Muniappa, N; Troth, S P; Bailey, W; Seng, J; Aslamkhan, A G; Thudium, D; Sistare, F D, and Gerhold, D L.
Strategic Paths for biomarker qualification
Toxicology. 2008 Mar 20;245(3):219-23. Epub 2008 Jan 6
Goodsaid FM, Frueh FW, Mattes W