Development of supplemental indications for already-approved drugs by the United States pharmaceutical industry.
We developed a confidential survey of the U.S. pharmaceutical industry to provide information on the nature, timing, and regulatory success of clinical research on supplemental indications during the ten-year period, 1978-1987.
Data were obtained from 39 firms on 249 approved new chemical entities (NCEs) and 16 NCEs with submitted new drug applications (NDAs) pending at the end of 1987.
Nearly half of the supplemental indication research initiated during the study period can be categorized as anti-infective or cardiovascular.
Mots-clés Pascal : Amérique du Nord, Amérique, Indication, Médicament, Recherche développement, Marketing, Forme commerciale, Brevet, Innovation, Etats Unis, Industrie pharmaceutique
Mots-clés Pascal anglais : North America, America, Indication, Drug, Research and development, Marketing, Commercial form, Patents, Innovation, United States, Pharmaceutical industry
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 91-0413049
Code Inist : 002B02A03. Création : 199406.