NOVEL MEDICINES MARKETED IN THE UK (1960-87)
NOVEL MEDICINES MARKETED IN THE UK (1960-87)
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DOI：
10.1111/j.1365-2125.1989.tb05435.x
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发表时间：
1989-09-01
影响因子：
3.4
通讯作者：
WALKER, SR
中科院分区：
文献类型：
--
作者：
LIS, Y;WALKER, SR
1960年至1987年间，共有683种新化学实体（NCE）在英国上市。1964年，每年进入英国市场的NCE数量下降到平均每年20个，随后在1985年仅为7个。自1960年以来，平均开发时间增加了四倍，1984年达到峰值，为13年。有效专利寿命的相应下降导致自20世纪60年代中期以来平均有效专利寿命不到10年，自20世纪80年代初以来不超过6年，1987年上市的队列除外。临床阶段对总开发时间的贡献最大。对于20世纪60年代中期上市的NCE来说，它是3.3年，在20世纪80年代初增加到近8年的峰值，平均占研发时间的三分之二。从1960年到1970年代初，中枢神经系统（CNS）药物、心血管产品和抗感染药物的总开发时间分别增加了一倍，达到9年、8年和7.3年。到20世纪80年代，中枢神经系统药物的平均寿命为13年，分别比抗感染药物和心血管化合物长54%和28%。
A total of six hundred and eighty three new chemical entities (NCEs), were marketed in the UK between 1960 and 1987. The number of NCEs introduced annually onto the UK market declined to an average of 20 per year in 1964 and subsequently to only 7 in 1985. Average development times have increased fourfold since 1960 to a peak value of 13 years in 1984. The concomitant decline in effective patent life has resulted in a mean effective patent life of less than 10 years since the mid 1960s and no more than 6 years since the early 1980s, except for the cohort marketed in 1987. The largest contribution to total development time was made by the clinical phase. For NCEs marketed in the mid 1960s it was 3.3 years increasing to a peak of almost 8 years in the early 1980s, and representing on average two-thirds of research and development time. Between 1960 and the early 1970s total development time for central nervous system (CNS) agents, cardiovascular products and anti-infectives had doubled to 9, 8 and 7.3 years respectively. By the 1980s it was averaging 13 years for CNS agents and was 54% and 28% longer than for anti-infectives and cardiovascular compounds respectively.