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Synthesizing regulatory guidance for demonstrating preclinical efficacy and translating promising cell therapies to early phase clinical trials: a scoping review

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BMC MEDICINE 2024年第1期22卷 1页

作者： Jeffers, Matthew S. Xi, Cheng En Bapuji, Raj Wotherspoon, Hannah Kimmelman, Jonathan Bedford, Patrick McIsaac, Daniel I. Lalu, Manoj M. Fergusson, Dean A. Ottawa Hosp Clin Epidemiol Program Blueprint Translat Res Grp Res Inst Ottawa ON Canada Univ Ottawa Sch Epidemiol & Publ Hlth Ottawa ON Canada Univ Ottawa Telfer Sch Management Ottawa ON Canada McGill Univ Dept Equ Eth & Policy Studies Translat Eth & Med STREAM Montreal PQ Canada weCANreg Consulting Grp Inc Toronto ON Canada Morphocell Technol Inc Laval PQ Canada Univ Ottawa Dept Anesthesiol & Pain Med Ottawa ON Canada Univ Ottawa Dept Med Ottawa ON Canada

BackgroundRegulatory applications for cell therapy face more objections compared to conventional small molecule or biological drugs, leading to delays in market approval and clinical adoption. Increased regulatory objections frequently relate to issues regarding preclinical evidence, such as experimental design of animal studies, selection of animal models, endpoints, and determination of mechanism of action. Synthesis and clarification of the preclinical evidence necessary to demonstrate treatment efficacy and advance into early-phase clinical trials is needed to help researchers avoid regulatory *** conducted a scoping review in which we searched repositories of the International Council for Harmonisation and all national member organizations (N = 38) for documents related to preclinical studies of cell therapies. Active guidance documents related to cell therapy were included, with no restrictions based on the year or language of publication. Data extraction was conducted in duplicate with conflicts resolved through consensus *** 1215 identified documents, a total of 182 were included and analyzed, with 71% originating from ten major regulatory agencies. The most prevalent preclinical item addressed was the mechanism of action (n = 161, 88% of documents), underscoring its importance in bridging preclinical findings to clinical application. Most documents (n = 140, 77%) emphasized the importance of using clinically relevant preclinical models, though specific recommendations on models of disease were less common (n = 81, 45%). Selection of clinically relevant intervention parameters (n = 136, 75%) and outcome measures (n = 121, 66%) were also frequently recommended, but selection of relevant comparator groups appeared less frequently (n = 35, 19%). Furthermore, robust study design elements such as randomization and blinding were less frequently recommended, appearing in 31% of documents (n = 57). Comparison with clinical trial g

关键词： Preclinical Animal Cell therapy Stem cell Clinical trials International Council for Harmonisation Regulatory guidance Study design Best practice

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Hybrid Deep Neural Network for Data-Driven Missile guidance with Maneuvering Target

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DEFENCE SCIENCE JOURNAL 2023年第5期73卷 602-611页

作者： Farooq, Junaid Bazaz, Mohammad Abid Natl Inst Technol Srinagar Elect Engn Dept Srinagar 190006 India

Missile guidance, owing to highly complex and non-linear relative movement between the missile and its target, is a challenging problem. This is further aggravated in case of a maneuvering target which changes its own flight path while attempting to escape the incoming missile. In this study, to achieve computationally superior and accurate missile guidance, deep learning is employed to propose a self-tuning technique for a Fractional-Order Proportional Integral Derivative (FOPID) controller of a radar-guided missile chasing an intelligently maneuvering target. A multi-layer two-dimensional architecture is proposed for a deep neural network that combines the prediction feature of recurrent neural networks and estimation feature of feed-forward artificial neural networks. The proposed deep learning based missile guidance scheme is non-intrusive, data-based, and model-free wherein the parameters are optimized on-the-run while predicting the target's maneuvering tactics to correct for processing time and loop delays of the system. Using deep learning for online optimisation with minimal computational burden is the core feature of the proposed technique. Dual-core parallel simulations of missile-target dynamics and the control system were performed to demonstrate superiority of the proposed scheme in feasibility, adaptability, and the ability to effectively minimize the miss-distance in comparison with traditional and neural offline-tuned PID and FOPID based techniques. Compared to state-of-the-art offline-tuned neural control, the miss-distance was reduced by 68.42 % for randomly maneuvering targets. Furthermore, a minimum miss-distance of 0.97 m was achieved for intelligently maneuvering targets for which the state-of-the-art method failed to hit the target. Overall, the proposed technique offers a novel approach for addressing the challenges of missile guidance in a computationally efficient and effective manner.

关键词： Deep learning FOPID Missile guidance Neural network

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guidance, Navigation and Control of Couplable Unmanned Surface Vehicles

Guidance, Navigation and Control of Couplable Unmanned Surfa...

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OCEANS Conference

作者： Damerius, Robert Hahn, Tobias Karez, Ian Schubert, Agnes Kolewe, Bjoern Jeinsch, Torsten Univ Rostock Inst Automat Rostock Germany

ISBN: (纸本)9798350362077

The paper presents a comprehensive system concept for an electrically powered unmanned surface vehicle designed for single and convoy sailing on urban waterways. A description of the vehicle's equipment with regard to automated operation is given. The guidance, navigation and control system is described in detail and the individual sub-functions are explained. The focus lies on high-level automation tasks such as motion planning, automatic collision avoidance and automatic docking and undocking. The methods developed are tested by real experiments and the technical feasibility is demonstrated. Results on collision avoidance and coupling to a moored vehicle are presented. Finally, the paper addresses open problems that require further research.

关键词： unmanned surface vehicle guidance navigation control

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Neural Network-Based Controller for Terminal guidance Applied in Short-Range Rockets

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IEEE AEROSPACE AND ELECTRONIC SYSTEMS MAGAZINE 2023年第4期38卷 28-42页

作者： de Celis, Raul Cadarso, Luis Rey Juan Carlos Univ Madrid Spain Rey Juan Carlos Univ Aerosp & Transportat Res Grp Madrid 28933 Spain

Precision during the guided terminal flight in short-range rockets is a key factor that must be improved using several methodologies. Traditionally, inertial navigation systems allowed to unbind the accuracy concerning the range. Unfortunately, in short-range rockets, the response of the inertial-based controller has to be fast enough to correct the trajectory in a short time. This fact implies that to achieve high precision, either the use of systems too large to be implemented in portable rockets is required, or systems that are too expensive concerning the total cost of the rocket. For these systems, artificial intelligence-based guidance tactics could improve the precision, since once the network is trained, it is not necessary to know the dynamics of the vehicle, and the network itself can react quickly, simplifying the system and reducing economic costs using relatively simple electronics. The neural networks are trained using a nonlinear-dynamics model based on a simulated flight dynamics and verified with real flight data. The simulation results show that the proposed method works effectively in a six-degree-of-freedom simulation environment, with excellent accuracy and robustness to parameter uncertainty. The appropriateness of the closed-loop performance is validated using Monte Carlo analysis across a wide range of uncertainty scenarios.

关键词： Rockets Global navigation satellite system Navigation Neural networks Costs Kalman filters Vehicle dynamics Nonlinear-flight-mechanics Neural Networks guidance Navigation and Control Ballistic Rocket Machine Learning

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Three-Dimensional Optimal Homing guidance Without Terminal Maneuverability Advantage

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JOURNAL OF guidance CONTROL AND DYNAMICS 2023年第9期46卷 1774-1784页

作者： Li, Hongyan Tao, Hong Wang, Jiang He, Shaoming Beihang Univ Sch Elect Informat Engn Beijing 100191 Peoples R China Beijing Inst Technol Sch Aerosp Engn Beijing 100081 Peoples R China

This paper investigates the three-dimensional (3-D) homing guidance problem of intercepting an evasive target with maneuverability comparable to the missile. The guidance problem is first reformulated in the relative frame to help geometrically derive the necessary condition of interception without terminal maneuverability advantage in the 3-D space. A two-stage optimal guidance law is then analytically derived with bounded acceleration to satisfy the aforementioned necessary condition. Theoretical analysis is performed to interpret the working principle and physical meaning of the proposed law. The key feature of the proposed approach lies in its fast convergence rate and low acceleration requirement. Hence, in comparison with the existing optimal approaches, the proposed law can significantly improve the operational margin and decrease the risk of command saturation in the endgame. Extensive simulations are performed to support our findings.

关键词： Homing guidance guidance Navigation and Control Systems Linear Quadratic Gaussian Flight Path Angle Structural Kinematics and Dynamics Computational Fluid Dynamics Missile guidance and Control Proportional Navigation Autopilot Flight Control Surfaces

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An Adaptive Line-of-Sight (ALOS) guidance Law for Path Following of Aircraft and Marine Craft

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IEEE TRANSACTIONS ON CONTROL SYSTEMS TECHNOLOGY 2023年第6期31卷 2887-2894页

作者： Fossen, Thor I. Norwegian Univ Sci Dept Engn Cybernet N-7491 Trondheim Norway

This brief presents a novel nonlinear adaptive line-of-sight (ALOS) guidance law for path following, compensating for drift forces due to wind, waves, and ocean currents. The ALOS guidance law is proven to have uniform semiglobal exponential stability (USGES) properties during straight-line path following at constant speed. The ALOS guidance law performs similar to the classical integral line-of-sight (ILOS) and adaptive ILOS guidance laws when the sideslip angle is nearly constant. The ALOS guidance law, however, has better tracking capabilities when compensating for rapidly varying sideslip caused by a time-varying disturbance. This is because the integral state of the ALOS guidance law is additive to the unknown sideslip angle (disturbance matching). In contrast, the ILOS guidance laws must compensate sideslip through a saturating arctangent function. The study also includes an input-to-state stable (ISS) reduced-order extended state observer for estimation of the line-of-sight (LOS) crab angle, known as the ELOS guidance law. The performance of the ALOS, ILOS, and ELOS guidance laws is compared by simulating rapid changes in the sideslip angle to stress the critical assumptions of the algorithms. Finally, a case study of the Remus 100 autonomous underwater vehicle (AUV) exposed to stochastic ocean currents is used to compare the performance of the ILOS, ALOS, and ELOS algorithms during normal operation.

关键词： Adaptive systems Navigation Oceans Kinematics Stability analysis Autopilot Observers Adaptive control guidance land vehicles marine vehicles unmanned aerial vehicles (UAVs)

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Three-Dimensional guidance Method With Course Modification for Altitude Shaping in Endoatmospheric Interception

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IEEE TRANSACTIONS ON AEROSPACE AND ELECTRONIC SYSTEMS 2023年第6期59卷 9775-9791页

作者： Cho, Namhoon Cranfield Univ Ctr Autonomous & Cyber Phys Syst Sch Aerosp Transport & Mfg Cranfield MK43 0AL England

This study presents a 3-D guidance law for the interception of an endoatmospheric target. The proposed method takes an empirical design approach that first specifies the structure of the lateral acceleration command as that of a linear optimal guidance law for zero-effort-miss nullification. Then, the direction of pursuit and the guidance gain are designed in accordance with the physical understandings of the motion characteristics of an aerodynamically controlled interceptor. More specifically, the proposed method induces an intentional increase in the flight altitude around the initial phase while respecting the maximum altitude constraint, all of which are realized through modification of the desired flight path angle in the vertical plane. The proposed guidance method does not rely on the explicit definition of design elements, such as engagement planes, guidance phases, complicated time-to-go estimation, and waypoints. Moreover, the proposed design approach of modifying the desired course based on the collision courses naturally facilitates smooth handover to the terminal phase near the collision condition. Numerical simulation shows that the proposed guidance method is effective in intercepting a nonmaneuvering target over a wide range of engagement conditions to the target in comparison to the existing guidance laws developed for homing and midcourse flight.

关键词： Trajectory Missiles Aerodynamics Aircraft Optimization Mathematical models Atmospheric modeling 3-D final speed guidance interception course modification

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Three-Dimensional Spatial-Temporal Cooperative guidance Without Active Speed Control

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JOURNAL OF guidance CONTROL AND DYNAMICS 2023年第10期46卷 1981-1996页

作者： Dong, Wei Deng, Fang Wang, Chunyan Wang, Jianan Xin, Ming Beijing Inst Technol Natl Key Lab Autonomous Intelligent Unmanned Syst Beijing 100081 Peoples R China Beijing Inst Technol Sch Aerosp Engn Beijing 100081 Peoples R China Univ Missouri Dept Mech & Aerosp Engn Columbia MO 65211 USA Beijing Inst Technol Chongqing Innovat Ctr Chongqing 401120 Peoples R China

This paper investigates the three-dimensional (3D) spatial-temporal cooperative guidance problem for multiple missiles with time-varying speeds, which is addressed by a progressive design strategy. First, the zero miss distance and desired impact directions are realized by a 3D vector impact angle control guidance (IACG) law whose time-to-go is predicted accurately and efficiently by a numerical algorithm. Then, by introducing an implicit trajectory-to-go function, the time-to-go control mechanism is clearly revealed under missile speed variation. Accordingly, a coordinated biased term is added to the 3D vector IACG law to ensure a simultaneous attack. Finally, considering the seeker's field-of-view (FOV) limit, the resultant cooperative guidance law is further augmented by another biased term to prevent the lead angle from exceeding its upper bound. Unlike similar existing results, the proposed one can satisfy multiple complex spatial-temporal constraints without active speed control, thereby manifesting great practical significance. Several numerical simulations are provided to show the effectiveness and advantages of the proposed cooperative guidance law.

关键词： Sliding Mode Control Zero Lift Drag Coefficient guidance System Cooperative guidance Tactical and Strategic Missile guidance Missile guidance Homing guidance Impact Time Control guidance guidance Navigation and Control Intercept Angle guidance Law

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Polynomial guidance for Impact-Time Control Against Maneuvering Targets

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JOURNAL OF guidance CONTROL AND DYNAMICS 2023年第12期46卷 2388-2398页

作者： Li, Haojian Liu, Yuanhe Li, Kebo Liang, Yan'gang Natl Univ Def Technol Coll Aerosp Sci & Engn Changsha 410072 Hunan Peoples R China

To address the issue of intercepting maneuvering targets at a specific time, a polynomial guidance method for impact-time control is proposed in this paper. Based on the relative virtual framework and the classical differential geometry curve theory, such method is divided into two parts: 1) the design of the relative trajectory-length-control (RTLC) guidance law against virtual stationary targets, and 2) the design of the prediction algorithms based on the guidance law or its characteristics. The former realizes RTLC, and the latter establishes the relationship between the desired relative trajectory length-to-go and the desired time-to-go, thus implementing impact-time control. Furthermore, based on the analytical properties of the guidance law in the relative arc-length domain, its performance, characteristics, and allowable impact time are analyzed. Finally, the effectiveness of the proposed guidance method and the validity of the theoretical findings are verified by numerical simulations results.

关键词： guidance Navigation and Control Systems Prediction Algorithms Numerical Simulation Spacecraft guidance and Control Flight Path Angle Aerospace Sciences Proportional Navigation Missile guidance and Control Algorithms and Data Structures State Estimation

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Longitudinal-Acceleration-Based guidance Law for Maneuvering Targets Inspired by Hawk's Attack Strategy

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JOURNAL OF guidance CONTROL AND DYNAMICS 2023年第7期46卷 1437-1447页

作者： Paul, Nobin Ghose, Debasish Indian Inst Sci Guidance Control & Decis Syst Lab Dept Aerosp Engn Bangalore 560012 India

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