scholarly journals Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities

2021 ◽  
Author(s):  
Catherine Feng ◽  
Riddhi Virparia ◽  
Eric T.-K. Mui
Keyword(s):  
Real Time ◽  
Pilot Program ◽  
The Real ◽  
Oncology Review

U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program

2020 ◽  
Vol 27 (1) ◽  
pp. 11-14 ◽  
Author(s):  
R. Angelo de Claro ◽  
Jennifer J. Gao ◽  
Tamy Kim ◽  
Paul G. Kluetz ◽  
Marc R. Theoret ◽  
...  
Keyword(s):  
Real Time ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Initial Experience ◽  
The Real ◽  
Oncology Review

scholarly journals Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot

2022 ◽  
Author(s):  
Ya Grace Gao ◽  
Samantha Roberts ◽  
Allison Guy
Keyword(s):  
Real Time ◽  
Drug Application ◽  
Priority Review ◽  
Pilot Program ◽  
Regulatory Review ◽  
Oncology Review ◽  
The Us ◽  
Complex Features ◽  
Study Designs ◽  
Oncology Center

AbstractTo promote the efficient review of oncology drug applications, the US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) launched the Real-Time Oncology Review (RTOR) pilot program in 2018. RTOR allows FDA to review individual sections of eCTD modules of a drug application for oncology drugs in contrast to requiring the applicant to submit complete modules or the complete application before review is initiated. Initially, the program accepted only supplemental applications with simple study designs and easily interpretable endpoints, but the scope has since been expanded to include applications for New Molecular Entities (NME), and other applications with more complex features. Though many applicants experience faster approvals under RTOR, it is difficult to isolate the effect of the RTOR program on review timelines as its contribution is masked by other expedited programs like priority review and breakthrough therapy designation (BTD). This article discusses the expanded scope of RTOR, its interplay with other OCE initiatives to modernize regulatory review, summarizes Genentech’s experiences in planning RTOR submissions from February 2019 to July 2021, and provides considerations for the future of the program.

The Real-Time Neural Genesis of a Punchline

2014 ◽  
Author(s):  
Irving Biederman ◽  
Ori Amir
Keyword(s):  
Real Time ◽  
The Real

Real-Time System for Sending Data from Three Clients to One Server with MATLAB

2015 ◽  
Vol 2 (1) ◽  
pp. 35-41
Author(s):  
Rivan Risdaryanto ◽  
Houtman P. Siregar ◽  
Dedy Loebis
Keyword(s):  
Information System ◽  
Real Time ◽  
Time System ◽  
Real Time System ◽  
The Real ◽  
Performance Time ◽  
Data Process ◽  
Effectiveness And Efficiency

The real-time system is now used on many fields, such as telecommunication, military, information system, evenmedical to get information quickly, on time and accurate. Needless to say, a real-time system will always considerthe performance time. In our application, we define the time target/deadline, so that the system should execute thewhole tasks under predefined deadline. However, if the system failed to finish the tasks, it will lead to fatal failure.In other words, if the system cannot be executed on time, it will affect the subsequent tasks. In this paper, wepropose a real-time system for sending data to find effectiveness and efficiency. Sending data process will beconstructed in MATLAB and sending data process has a time target as when data will send.

The real-time computing of the Stirling formula based on hardware acceleration

2013 ◽  
Author(s):  
Jiyang Yu ◽  
Dan Huang ◽  
Siyang Zhao ◽  
Nan Pei ◽  
Huixia Cheng ◽  
...  
Keyword(s):  
Real Time ◽  
Hardware Acceleration ◽  
Stirling Formula ◽  
The Real ◽  
Real Time Computing

Using graphs to construct a math model of a microcontroller-based system for preset rate control of a flywheel motor to be used in high-dynamics spacecraft

2020 ◽  
pp. 126-134
Author(s):  
Vladimir V. NEKRASOV
Keyword(s):  
Real Time ◽  
Rotation Rate ◽  
Control Function ◽  
Real Time Control ◽  
Math Model ◽  
The Real ◽  
Time Control ◽  
Power Matrix ◽  
High Dynamics ◽  
Stated Problem

Developing a microcontroller-based system for controlling the flywheel motor of high-dynamics spacecraft using Russian-made parts and components made it possible to make statement of the problem of searching control function for a preset rotation rate of the flywheel rotor. This paper discusses one of the possible options for mathematical study of the stated problem, namely, application of structural analysis based on graph theory. Within the framework of the stated problem a graph was constructed for generating the new required rate, while in order to consider the stochastic case option the incidence and adjacency matrices were constructed. The stated problem was solved using a power matrix which transforms a set of contiguous matrices of the graph of admissible solution edge sequences, the real-time control function was found. Based on the results of this work, operational trials were run for the developed control function of the flywheel motor rotor rotation rate, a math model was constructed for the real-time control function, and conclusions were drawn about the feasibility of implementing the results of this study. Key words: Control function, graph, incidence matrix, adjacency matrix, power matrix, microcontroller control of the flywheel motor, highly dynamic spacecraft.

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