Post-authorization research, registries, and drug development;Ricerca post-autorizzativa, registri e sviluppo del farmaco

Recenti Progressi in Medicina

Volumn 104, Issue 6, 2013, Pages 275-279

  Patarnello, Francesca ^a   Recchia, Giuseppe ^a,b  

^a GSK   (Italy)

^b Gruppo Sperimentazione Clinica   (Italy)

Author keywords

Post authorization research; Registries; Technology assessment

Indexed keywords

CLINICAL PRACTICE; DRUG COST; DRUG EFFICACY; DRUG INDUSTRY; DRUG MONITORING; DRUG RESEARCH; DRUG SAFETY; DRUG USE; DRUG UTILIZATION; ITALY; REGISTER; REIMBURSEMENT; REVIEW; RISK BENEFIT ANALYSIS;

BIOMEDICAL RESEARCH; DRUG INDUSTRY; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; REGISTRIES;

EID: 84879381530     PISSN: 00341193     EISSN: 20381840     Source Type: Journal    
DOI: None     Document Type: Review

References (7)

1. Epstein RS. R&D transformation and value-based innovation. J Comp Eff Res 2012; 1: 1-2.
2. Epstein RS, Sidorov J, Lehner JP, Salimi T. Integrating scientific and real-world evidence within and beyond the drug development process. J Comp Eff Res 2012; 1: 9-13.
3. Sheridan C. Drugmakers use real-world patient data to calibrated product development. Nat Biotechnol 2011; 29: 778.
4. http://www.fondazioneicona.org
5. Woodcock J, Woosley R. The FDA critical path initiative and its influence on new drug development. Annu Rev Med 2008; 59: 1-12. (Pubitemid 351287920)
6. Patarnello F, Recchia G, Ricciardi W. Sole24Ore Sanità, 2011, Anno XIV.
7. The Association of the British Pharmaceutical Industry -ABPI. Demonstrating value with Real World data, 2011. http://www.abpi.org.uk/our-work/ library/guidelines/Pages/real-world-data.aspx