Development and regulatory strategies for drug and diagnostic co-development.

Autor: Hinman LM; Novartis Pharmaceuticals Corp., East Hanover, NJ 07939-1080, USA. lois.hinman@novartis.com, Carl KM, Spear BB, Salerno RA, Becker RL, Abbott BM, Kelly JF, Mansfield E, Katz RG, Harper C, Day SP, Pacanowski MA, Pignato W
Jazyk: angličtina
Zdroj: Pharmacogenomics [Pharmacogenomics] 2010 Dec; Vol. 11 (12), pp. 1669-75.
DOI: 10.2217/pgs.10.141
Abstrakt: 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: MEDLINE