Development and regulatory strategies for drug and diagnostic co-development

Autor:	James F. Kelly, Ronald A Salerno, Kevin Carl, Brian B Spear, Lois Hinman, Brian M. Abbott, Courtney Harper, Elizabeth Mansfield, Stephen P. Day, Russell Katz, Robert L. Becker, Michael Pacanowski, William Pignato
Rok vydání:	2010
Předmět:	Pharmacology Drug business.industry media_common.quotation_subject Co-development Biotechnology Risk analysis (engineering) Drug development Pharmacogenomics Genetics Molecular Medicine Identification (biology) business Companion diagnostic media_common
Zdroj:	Pharmacogenomics. 11:1669-1675
ISSN:	1744-8042 1462-2416
DOI:	10.2217/pgs.10.141
Popis:	At the 5th FDA–Drug Industry Association (DIA) Workshop on ‘Pharmacogenomics in Drug Development and Regulatory Decision Making’, track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and their companion diagnostic products. Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit–risk paradigm for new drugs.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::0f66ac66a4084683f4c33122dbdca15e https://doi.org/10.2217/pgs.10.141 Zobrazit plný text záznamu