Autor: "Jacobson-Kram D" - OpacWWW

Skocz do pozycji: 1.

Tytuł:: Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Autorzy:: Goodsaid FM; Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, Maryland 20903-002, USA. />Amur S
Aubrecht J
Burczynski ME
Carl K
Catalano J
Charlab R
Close S
Cornu-Artis C
Essioux L
Fornace AJ Jr
Hinman L
Hong H
Hunt I
Jacobson-Kram D
Jawaid A
Laurie D
Lesko L
Li HH
Lindpaintner K
Mayne J
Morrow P
Papaluca-Amati M
Robison TW
Roth J
Schuppe-Koistinen I
Shi L
Spleiss O
Tong W
Truter SL
Vonderscher J
Westelinck A
Zhang L
Zineh I; Pokaż więcej
Źródło:: Nature reviews. Drug discovery [Nat Rev Drug Discov] 2010 Jun; Vol. 9 (6), pp. 435-45.
Typ publikacji:: Recenzja
MeSH Terms:: Drug Approval*
Gene Expression Profiling*
United States Food and Drug Administration*
Alanine Transaminase/blood ; Azetidines/adverse effects ; Azetidines/therapeutic use ; Benzylamines/adverse effects ; Benzylamines/therapeutic use ; Carcinoma, Renal Cell/diagnosis ; Europe ; Fluorouracil/adverse effects ; Genetic Markers ; Humans ; International Cooperation ; Kidney Neoplasms/diagnosis ; Kidney Transplantation ; Pharmacogenetics ; Piperazines/pharmacokinetics ; Piperazines/therapeutic use ; Prasugrel Hydrochloride ; Precision Medicine ; Thiophenes/pharmacokinetics ; Thiophenes/therapeutic use ; United States

Recenzja

Skocz do pozycji: 2.

Tytuł:: Towards consensus practices to qualify safety biomarkers for use in early drug development.
Autorzy:: Sistare FD; Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA. frank_ />Dieterle F
Troth S
Holder DJ
Gerhold D
Andrews-Cleavenger D
Baer W
Betton G
Bounous D
Carl K
Collins N
Goering P
Goodsaid F
Gu YZ
Guilpin V
Harpur E
Hassan A
Jacobson-Kram D
Kasper P
Laurie D
Lima BS
Maciulaitis R
Mattes W
Maurer G
Obert LA
Ozer J
Papaluca-Amati M
Phillips JA
Pinches M
Schipper MJ
Thompson KL
Vamvakas S
Vidal JM
Vonderscher J
Walker E
Webb C
Yu Y; Pokaż więcej
Źródło:: Nature biotechnology [Nat Biotechnol] 2010 May; Vol. 28 (5), pp. 446-54. Date of Electronic Publication: 2010 May 10.
Typ publikacji:: Journal Article
MeSH Terms:: Biomarkers*
Drug Discovery*/legislation & jurisprudence
Drug Discovery*/methods
Pharmaceutical Preparations*/standards
Animals ; Drug-Related Side Effects and Adverse Reactions ; Humans

Czasopismo naukowe

Skocz do pozycji: 3.

Tytuł:: Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.
Autorzy:: Dieterle F; Novartis Pharma AG, Basel, Switzerland. />Sistare F
Goodsaid F
Papaluca M
Ozer JS
Webb CP
Baer W
Senagore A
Schipper MJ
Vonderscher J
Sultana S
Gerhold DL
Phillips JA
Maurer G
Carl K
Laurie D
Harpur E
Sonee M
Ennulat D
Holder D
Andrews-Cleavenger D
Gu YZ
Thompson KL
Goering PL
Vidal JM
Abadie E
Maciulaitis R
Jacobson-Kram D
Defelice AF
Hausner EA
Blank M
Thompson A
Harlow P
Throckmorton D
Xiao S
Xu N
Taylor W
Vamvakas S
Flamion B
Lima BS
Kasper P
Pasanen M
Prasad K
Troth S
Bounous D
Robinson-Gravatt D
Betton G
Davis MA
Akunda J
McDuffie JE
Suter L
Obert L
Guffroy M
Pinches M
Jayadev S
Blomme EA
Beushausen SA
Barlow VG
Collins N
Waring J
Honor D
Snook S
Lee J
Rossi P
Walker E
Mattes W; Pokaż więcej
Źródło:: Nature biotechnology [Nat Biotechnol] 2010 May; Vol. 28 (5), pp. 455-62. Date of Electronic Publication: 2010 May 10.
Typ publikacji:: Journal Article
MeSH Terms:: Biomarkers, Pharmacological*
Kidney*/drug effects
Kidney*/injuries
Drug Approval/*legislation & jurisprudence
Animals ; Drug-Related Side Effects and Adverse Reactions ; Europe ; Humans ; Pharmaceutical Preparations/standards ; United States ; United States Food and Drug Administration

Czasopismo naukowe

Skocz do pozycji: 4.

Tytuł:: Issues in the design and interpretation of chronic toxicity and carcinogenicity studies in rodents: approaches to dose selection.
Autorzy:: Rhomberg LR; Gradient Corporation, Cambridge, Massachusetts, USA.
Baetcke K
Blancato J
Bus J
Cohen S
Conolly R
Dixit R
Doe J
Ekelman K
Fenner-Crisp P
Harvey P
Hattis D
Jacobs A
Jacobson-Kram D
Lewandowski T
Liteplo R
Pelkonen O
Rice J
Somers D
Turturro A
West W
Olin S; Pokaż więcej
Źródło:: Critical reviews in toxicology [Crit Rev Toxicol] 2007; Vol. 37 (9), pp. 729-837.
Typ publikacji:: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.; Review
MeSH Terms:: Dose-Response Relationship, Drug*
Carcinogenicity Tests/*methods
Animals ; Carcinogens/toxicity ; Humans ; Research Design ; Rodentia

Czasopismo naukowe

Skocz do pozycji: 5.

Tytuł:: Pharmacogenomics and regulatory decision making: an international perspective.
Autorzy:: Mendrick DL; Toxicogenomics, Gene Logic Inc., Gaithersburg, MD 20879, USA. />Brazell C
Mansfield EA
Pietrusko R
Barilero I
Hackett J
Stürzebecher S
Jacobson-Kram D; Pokaż więcej
Źródło:: The pharmacogenomics journal [Pharmacogenomics J] 2006 May-Jun; Vol. 6 (3), pp. 154-7.
Typ publikacji:: Journal Article
MeSH Terms:: Decision Making, Organizational*
Internationality*
Pharmacogenetics*
Biomarkers

Czasopismo naukowe

Skocz do pozycji: 6.

Tytuł:: Use of genotoxicity data to support clinical trials or positive genetox findings on a candidate pharmaceutical or impurity .... now what?
Autorzy:: Jacobson-Kram D; Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA. />Jacobs A; Pokaż więcej
Źródło:: International journal of toxicology [Int J Toxicol] 2005 May-Jun; Vol. 24 (3), pp. 129-34.
Typ publikacji:: Lecture
MeSH Terms:: Drug Contamination*
Drug Evaluation, Preclinical*
Mutagenicity Tests*
Clinical Trials as Topic/*standards
Drugs, Investigational/*toxicity
Animals ; Drug Approval ; Humans ; Risk Assessment

Informacja