Diseños adaptativos y otros diseños innovadores.

 

El punto de vista de los reguladores. 

Programa amife

Presentación
pps // pdf

Algunas referencias y material adicional:   

 

·       Algunos artículos

o   Dragalin V. Adaptive Designs: Terminology and Classification. Drug Information Journal 2006, (40):425435

o   Quinlan JA, Krams M. Implementing Adaptive Designs: Logistical and Operational Considerations. Drug Information Journal 2006, (40):437444

o   Gallo P, Krams M. PhRMA Working Group on Adaptive Designs: Introduction to the Full White Paper. Drug Information Journal 2006, (40):421423

o   Maca J, Bhattacharya S, Dragalin V, Gallo P, Krams M. Adaptive Seamless Phase II/III Designs- Background, Operational Aspects, and Examples. Drug Information Journal 2006, (40):463-473

 

 



Ferran Torres, MD, PhD (Ferran.Torres@uab.es)

 

 

USEM. Statistics and Methodology Support Unit

Unitat de Suport en Estadística i Metodología

Clinical Pharmacology Dpt. - Unit of Support Assessment and Prevention (UASP)

Hospital Clinic Barcelona

Courier & Physical Address: C/ Rosselló, 138. Office #27. 08036 Barcelona, Spain

Postal address: C/ Villarroel 170. 08036 Barcelona, Spain

Phone: +34 932 279 328 / Fax: +34 932 279 877  (http://www.hospitalclinic.org)

 

Biostatistics Unit. School of Medicine. Office M3/323B.

Universitat Autònoma de Barcelona (UAB)

08193 Bellaterra (Barcelona). Spain (http://www.uab.es)


EMA (European Medicines Agency)

Miembro del Biostatistics Working Party BSWP

Miembro del Scientific Advice Working Party SAWP