title: The development of self-originated new drugs by Swiss pharmaceutical firms, 1960-1980.
abstract: This study of the development and regulation of self-originated new chemical entities (NCEs) in Switzerland between 1960 and 1980 is based on confidential data obtained through a survey of the three largest Swiss companies. Analyses of these data allowed description of the changes over time in (1) the number of NCEs introduced into clinical testing each year, (2) the time required to test and gain approval for a new drug, and (3) the success rate for NCEs, i.e., the proportion of those tested in man that received marketing approval. Because Swiss regulations may have an impact on these trends, the possible relationship between major regulatory events and changes in research activity is examined. Other factors such as regulatory requirements in major foreign markets and international economic influences are also considered.
mesh_terms: D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D006801:Humans; D007880:Legislation, Drug; D012106:Research; D013557:Switzerland; D013678:Technology, Pharmaceutical; D013997:Time Factors