Takeda Pharmaceuticals, 40 Landsdowne, St. Cambridge, MA, 02139, USA.
Ther Innov Regul Sci. 2021 May;55(3):553-557. doi: 10.1007/s43441-020-00249-6. Epub 2020 Dec 26.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-19; HCoV-19; COVID-19) has affected all daily activities. Has it also affected the number of United States (FDA) drug approvals over time? The short answer from empirical time series forecasting is not yet. Care should be taken as the crisis continues through maintaining the scientific, economic, political, and social supportive structures to sustain momentum. This conclusion is based on analyzing the results of (non-overlapping) forecasting routines (viz., complex exponential smoothing, auto-regressive fractionally integrated moving average, extreme learning machine, and multi-layer perceptron) performed on longitudinal (1939-present) FDA (CDER) drug approvals taking into regard pre- and extant-COVID-19 eras. This is an initial study and there are caveats with the approach, and as such, all data and programs are provided to support replication of the results and furthering of the investigation.
严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-19；HCoV-19；COVID-19）已经影响了所有日常活动。它是否也随着时间的推移影响了美国食品和药物管理局（FDA）的药物批准数量？从经验时间序列预测的简短答案是还没有。随着危机通过维持科学、经济、政治和社会支持结构来维持势头而持续下去，应该谨慎行事。这一结论是基于对纵向（1939 年至今）FDA（CDER）药物批准进行（非重叠）预测例程（即，复杂指数平滑、自回归分数积分移动平均、极限学习机和多层感知器）的分析结果得出的，同时考虑了 COVID-19 之前和存在期间的时期。这是一项初步研究，该方法存在一些注意事项，因此提供了所有数据和程序，以支持结果的复制和进一步调查。
