D
David Jacobson-Kram
Researcher at Center for Drug Evaluation and Research
Publications - 73
Citations - 3246
David Jacobson-Kram is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Sister chromatid exchange & Drug development. The author has an hindex of 32, co-authored 73 publications receiving 3104 citations. Previous affiliations of David Jacobson-Kram include Food and Drug Administration & Johns Hopkins University.
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Journal ArticleDOI
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
Frank Dieterle,Frank D. Sistare,Federico Goodsaid,Marisa Papaluca,Josef S Ozer,Josef S Ozer,Craig P. Webb,William Baer,Anthony J. Senagore,Matthew J. Schipper,Jacky Vonderscher,Stefan Sultana,David Gerhold,Jonathan A. Phillips,Gerard Maurer,Kevin Carl,David Laurie,Ernie Harpur,Manisha Sonee,Daniela Ennulat,Dan Holder,Dina Andrews-Cleavenger,Yi Zhong Gu,Karol L. Thompson,Peter L. Goering,Jean Marc Vidal,Eric Abadie,Romaldas Mačiulaitis,David Jacobson-Kram,Albert F. Defelice,Elizabeth Hausner,Melanie Blank,Aliza Thompson,Patricia Harlow,Douglas C. Throckmorton,Shen Xiao,Nancy Xu,William Taylor,Spiros Vamvakas,Bruno Flamion,Beatriz Silva Lima,Peter Kasper,Markku Pasanen,Markku Pasanen,Krishna Prasad,Sean P. Troth,Denise Bounous,Denise Robinson-Gravatt,Graham Betton,Myrtle Davis,Jackie Akunda,James Eric McDuffie,Laura Suter,Leslie A. Obert,Magalie Guffroy,Mark Pinches,Supriya Jayadev,Eric A.G. Blomme,Sven A. Beushausen,Valérie G. Barlow,Nathaniel Collins,Nathaniel Collins,Jeff Waring,David Honor,Sandra Snook,Jinhe Lee,Phil Rossi,Elizabeth G. Walker,William B. Mattes +68 more
TL;DR: This was a pilot process, and the experience gained will both facilitate better understanding of how the qualification process will probably evolve and clarify the minimal requirements necessary to evaluate the performance of biomarkers of organ injury within specific contexts.
Journal ArticleDOI
Health Effects of Depleted Uranium on Exposed Gulf War Veterans
Melissa A. McDiarmid,Melissa A. McDiarmid,James P. Keogh,James P. Keogh,Frank J. Hooper,Kathleen McPhaul,Katherine Squibb,Robert L. Kane,Robert L. Kane,Raymond K. DiPino,Raymond K. DiPino,Michael Kabat,Michael Kabat,Bruce Kaup,Bruce Kaup,Larry D. Anderson,Dennis Hoover,Lawrence Brown,Lawrence Brown,Matthew M. Hamilton,David Jacobson-Kram,Belton A. Burrows,Mark Walsh +22 more
TL;DR: DU-exposed Gulf War veterans with retained metal shrapnel fragments are excreting elevated levels of urinary uranium 7 years after first exposure, suggesting on-going mobilization from a storage depot which results in a chronic systemic exposure.
Journal ArticleDOI
ReviewSister-chromatid exchange: second report of the Gene-Tox program
James D. Tucker,Angela E. Auletta,Michael C. Cimino,Kerry L. Dearfield,David Jacobson-Kram,Raymond R. Tice,Anthony V. Carrano +6 more
TL;DR: In this article, the ability of a number of chemicals to induce sister-chromatid exchanges (SCEs) was reviewed, and the SCE data for animal cells in vivo and in vitro, and human cells in vitro were presented in 6 tables according to their relative effectiveness.
Journal ArticleDOI
Health effects of depleted uranium on exposed Gulf War veterans: a 10-year follow-up.
Melissa A. McDiarmid,Susan M. Engelhardt,Marc Oliver,Patricia Gucer,P. David Wilson,Robert L. Kane,Michael Kabat,Bruce Kaup,Larry D. Anderson,Dennis Hoover,Lawrence Brown,Barry S. Handwerger,Richard J. Albertini,David Jacobson-Kram,Craig D. Thorne,Katherine Squibb +15 more
TL;DR: Medical surveillance of a group of U.S. Gulf War veterans who were victims of depleted uranium (DU) “friendly fire” reveals a persistent elevation of urine uranium, more than 10 yr after exposure, in those veterans with retained shrapnel fragments.
Journal ArticleDOI
Towards consensus practices to qualify safety biomarkers for use in early drug development.
Frank D. Sistare,Frank Dieterle,Sean P. Troth,Daniel J. Holder,David Gerhold,Dina Andrews-Cleavenger,William Baer,Graham Betton,Denise Bounous,Kevin Carl,Nathaniel Collins,Peter L. Goering,Federico Goodsaid,Yi Zhong Gu,Valerie Guilpin,Ernie Harpur,Alita Hassan,David Jacobson-Kram,Peter Kasper,David Laurie,Beatriz Silva Lima,Romaldas Mačiulaitis,William B. Mattes,Gerard Maurer,Leslie A. Obert,Josef S. Ozer,Marisa Papaluca-Amati,Jonathan A. Phillips,Mark Pinches,Matthew J. Schipper,Karol L. Thompson,Spiros Vamvakas,Jean Marc Vidal,Jacky Vonderscher,Elizabeth G. Walker,Craig P. Webb,Yan Yu +36 more
TL;DR: It is important during the biomarker evaluation process that stakeholders seek agreement on which critical experiments are needed to test that a biomarker meets specific performance claims, how new biomarker and traditional comparators will be measured and how the resulting data will be merged, analyzed and interpreted.