Voluntary exploratory data submissions to the US FDA and the EMA: Experience and impact

Nature Reviews Drug Discovery

Volumn 9, Issue 6, 2010, Pages 435-445

  Goodsaid, Federico M ^a   Amur, Shashi ^a   Aubrecht, Jiri ^b   Burczynski, Michael E ^c   Carl, Kevin ^d   Catalano, Jennifer ^a   Charlab, Rosane ^a   Close, Sandra ^e   Cornu Artis, Catherine ^d   Essioux, Laurent ^f   Fornace, Albert J ^g   Hinman, Lois ^d   Hong, Huixiao ^h   Hunt, Ian ⁱ   Jacobson Kram, David ^a   Jawaid, Ansar ⁱ   Laurie, David ^d   Lesko, Lawrence ^a   Li, Heng Hong ^g   Lindpaintner, Klaus ^j   Mayne, James ^b   Morrow, Peter ^e   Papaluca Amati, Marisa ^k   Robison, Timothy W ^a   Roth, John ^c   Schuppe Koistinen, Ina ⁱ   Shi, Leming ^h   Spleiss, Olivia ^f   Tong, Weida ^h   Truter, Sharada L ^b   Vonderscher, Jacky ^c   Westelinck, Agnes ^l   Zhang, Li ^a   Zineh, Issam ^a   more..

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b PFIZER INC   (United States)

^c HOFFMANN LA ROCHE INC   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

^e ELI LILLY AND COMPANY   (United States)

^f F HOFFMANN LA ROCHE LTD   (Switzerland)

^g GEORGETOWN UNIVERSITY   (United States)

^h NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH   (United States)

ⁱ ASTRAZENECA R AND D   (Sweden)

^j Strategic Diagnostics Incorporated   (United States)

^k EUROPEAN MEDICINES AGENCY   (United Kingdom)

^l GLAXOSMITHKLINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; CARCINOGEN; CYTOCHROME P450 1A2; CYTOCHROME P450 2B6; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DIHYDROPYRIMIDINE DEHYDROGENASE; EFFIENT; FLUOROURACIL; FOLINIC ACID; PRASUGREL; TEMSIROLIMUS; UNCLASSIFIED DRUG; XIMELAGATRAN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL TRIAL; DISEASE MARKER; DRUG APPROVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG METABOLISM; DRUG RESEARCH; DRUG RESPONSE; DRUG TOLERABILITY; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; GENE EXPRESSION PROFILING; GENE MUTATION; GENETIC TRANSCRIPTION; GENOTOXICITY; HUMAN; KIDNEY ALLOGRAFT; KIDNEY CARCINOMA; NONHUMAN; PHARMACOGENOMICS; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; SINGLE NUCLEOTIDE POLYMORPHISM; THROMBOEMBOLISM; TOXICOGENETICS; UNITED STATES; UNSPECIFIED SIDE EFFECT;

ALANINE TRANSAMINASE; AZETIDINES; BENZYLAMINES; CARCINOMA, RENAL CELL; DRUG APPROVAL; EUROPE; FLUOROURACIL; GENE EXPRESSION PROFILING; GENETIC MARKERS; HUMANS; INDIVIDUALIZED MEDICINE; INTERNATIONAL COOPERATION; KIDNEY NEOPLASMS; KIDNEY TRANSPLANTATION; PHARMACOGENETICS; PIPERAZINES; THIOPHENES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77953158485     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3116     Document Type: Review

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