Development of a Consumer Reported Outcome Measure for Personal Care Products : The Rationale

© 2024 The Author(s). This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY), https://creativecommons.org/licenses/by/4.0/Background: Cosmetic products are one of the fastest-growing segments of personal care products in the United States. One of the critical elements in the sales and growth of cosmetics is leveraging claims. Unlike pharmaceuticals in the US, claims in personal care products are usually not reviewed nor require regulatory approvals before products are sold in the US. However, regulatory agencies have no oversight of how the advertisement is presented to the consumers and have cited known companies and brands for promoting deceptive advertising and forcing costly market withdrawal, impacting the financial values of investors and customers' confidence alike. Objectives: We conducted a literature search and a survey. The literature search was to identify the current methodologies available for substantiating the advertisement of personal care products (including cosmetics). The survey was conducted with regulatory professionals aiming to understand the use of the current methodologies. Methods: The survey was developed and distributed to regulatory professionals in different capacities within the Cosmetic and Personal Care industry who had extensive experience constructing and substantiating advertising claims regulatory for cosmetic and personal care products. The questionnaire comprised 9 questions with socio-demographic characteristics and regulatory experience validating claims. Results: We received 63 responses from 1354 forms sent from regulatory professionals validating advertising claims. The results show that 85 % of the respondents use the FDA guidance while the remaining 15 % use in-house or other non-governmental guides. Moreover, 58 % use some Risk Benefit, while 42 % do not use it when evaluating claim substantiation. Conclusion: Although the respondents qualifying the claims possess the experience and technical knowledge of Cosmetic and Personal Care Products, the presently available standards used in the US are not designed to validate the substantiation of advertising claims. Therefore, there is a need to develop a more robust methodology for the evaluation of the validation and substantiation of advertising claims. A technique of using personal experiences is already approved and used for pharmaceutical products known as Personal Reported Outcomes (PRO). Leveraging the PRO techniques can help develop a “consumer reported outcome measure” (CROM) tool for claim substantiation validation for the advertising of cosmetic and personal care products. Keywords : Personal Reported Outcomes, CROM, FDA, FTC, Cosmetic productsPeer reviewe

An approximate solution to the optimal coordination problem for autonomous vehicles at intersections

In this paper, we address the problem of optimal and safe coordination of autonomous vehicles through a traffic intersection. We state the problem as a finite time, constrained optimal control problem, a combinatorial optimization problem that is difficult to solve in real-time. A low complexity computational scheme is proposed, based on a hierarchical decomposition of the original optimal control formulation, where a central coordination problem is solved together with a number of local optimal control problems for each vehicle. We show how the proposed decomposition allows a reduction of the complexity of the central problem, provided that approximated parametric solutions of the local problems are available beforehand. We derive conditions for the construction of the parametric approximations and demonstrate the method with a numerical example

Optimisation-based coordination of connected, automated vehicles at intersections

In this paper, we analyse the performance of a model predictive controller for coordination of connected, automated vehicles at intersections. The problem has combinatorial complexity, and we propose to solve it approximately by using a two stage procedure where (1) the vehicle crossing order in which the vehicles cross the intersection is found by solving a mixed integer quadratic program and (2) the control commands are subsequently found by solving a nonlinear program. We show that the controller is persistently safe and compare its performance against traffic lights and two simpler optimisation-based coordination schemes. The results show that our approach outperforms the considered alternatives in terms of both energy consumption and travel-time delay, especially for medium to high traffic loads

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This report describes 2 cases of ureteral obstruction secondary to endometriosis managed with robotic-assisted laparoscopic partial ureterectomy and ureteroneocystostomy

Coordination of Cooperative Autonomous Vehicles Toward safer and more efficient road transportation

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Measurements of Si Hybrid CMOS X-Ray Detector Characteristics

The development of Hybrid CMOS Detectors (HCDs) for X-Ray telescope focal planes will place them in con- tention with CCDs on future satellite missions due to their faster frame rates, flexible readout scenarios, lower power consumption, and inherent radiation hardness. CCDs have been used with great success on the current generation of X-Ray telescopes (e.g. Chandra, XMM, Suzaku, and Swift). However their bucket-brigade read-out architecture, which transfers charge across the chip with discrete component readout electronics, results in clockrate limited readout speeds that cause pileup (saturation) of bright sources and an inherent susceptibility to radiation induced displacement damage that limits mission lifetime. In contrast, HCDs read pixels with low power, on-chip multiplexer electronics in a random access fashion. Faster frame rates achieved with multi-output readout design will allow the next generation's larger effective area telescopes to observe bright sources free of pileup. Radiation damaged lattice sites effect a single pixel instead of an entire row. Random access, multi-output readout will allow for novel readout modes such as simultaneous bright-source-fast/whole-chip-slow readout. In order for HCDs to be useful as X-Ray detectors, they must show noise and energy resolution performance similar to CCDs while retaining advantages inherent to HCDs. We will report on readnoise, conversion gain, and energy resolution measurements of an X-Ray enhanced Teledyne HAWAII-1RG (H1RG) HCD and describe techniques of H1RG data reduction.Comment: 11 pages, 10 figure

Pooled safety analysis from phase III studies of trifluridine/tipiracil in patients with metastatic gastric or gastroesophageal junction cancer and metastatic colorectal cancer

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