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Bile acid synthesis defects (BASDs) comprise a group of rare diseases that can be severely disabling. Bile acid supplementation with 5 to 15 mg/kg cholic acid (CA) has been hypothesized to decrease endogenous bile acid production, stimulate bile secretion, and improve bile flow and micellar solubilization, thereby improving the biochemical profile and potentially slowing down disease progression. Currently, CA treatment is unavailable in the Netherlands, and CA capsules were compounded by the Amsterdam UMC Pharmacy from CA raw material. This study aims to determine the pharmaceutical quality and stability of the pharmacy compounded CA capsules. Pharmaceutical quality tests were performed on 25 mg and 250 mg CA capsules according to general monographs of the European Pharmacopoeia 10th ed. For the stability study, the capsules were stored under long-term conditions (25 °C ± 2 °C/60% ± 5% RH) and accelerated conditions (40 °C ± 2 °C/75% ± 5% RH). Samples were analyzed at 0, 3, 6, 9 and 12 months. The findings demonstrate that the pharmacy compounded CA capsules within a range of 25–250 mg that complied with the European regulations in regard to product quality and safety. The pharmacy compounded CA capsules are suitable for use in patients with BASD, as clinically indicated. With its simple formulation, pharmacies are provided a guidance on product validation and stability testing when commercial CA capsules are unavailable.

Transpiration is a key process driving energy, water and thus carbon dynamics. Global transpiration products are fundamental for understanding and predicting vegetation processes. However, validation of these transpiration products is limited, mainly due to lack of suitable data sets. We propose a method to use SAPFLUXNET, the first quality-controlled global tree sap flow (SF) database, for evaluating transpiration products at global scale. Our method is based on evaluating temporal mismatches, rather than absolute values, by standardizing both transpiration and SF products. We evaluate how transpiration responses to hydro-meteorological variation from the Global Land Evaporation Amsterdam Model (GLEAM), a widely used global transpiration product, compare to in situ responses from SAPFLUXNET field data. Our results show GLEAM and SAPFLUXNET temporal trends are in good agreement, but diverge under extreme conditions. Their temporal mismatches differ depending on the magnitude of transpiration and are not random, but linked to energy and water availability. Despite limitations, we show that the new global SAPFLUXNET data set is a valuable tool to evaluate T products and identify problematic assumptions and processes embedded in models. The approach we propose can, therefore, be the foundation for a wider use of SAPFLUXNET, a new, independent, source of information, to understand the mechanisms controlling global transpiration fluxes.Plain Language Summary Transpiration, the water evaporating from leaves, is a key element in the energy, water and carbon cycles of terrestrial ecosystems. Understanding patterns of transpiration at global scales is fundamental for prediction of future climates. Several models are used for estimating global transpiration, however identifying limitations and biases in these models is difficult, because we lack field data to compare them against. In this work, we propose a new method to enable tree-level sap flow (SF) data from SAPFLUXNET, the first global SF database, to be used to evaluate transpiration products and models. We evaluated how well GLEAM, a widely used transpiration product, matches SAPFLUXNET field data. We found GLEAM and SAPFLUXNET data to be in reasonable agreement however, mismatches occur under extreme dry or wet meteorological conditions, conditions which are likely to become more common under future climates. The detection of mismatches between SAPFLUXNET and GLEAM data is valuable for the identification of model processes and assumptions which could be reasonable within current climate, but inadequate for future climate conditions. The method we propose allows the use of SAPFLUXNET to understand the true mechanisms controlling global transpiration providing a new, independent, source of information to evaluate transpiration products and models.

In preparation of the German spaceborne imaging spectroscopy mission EnMAP (The Environmental Mapping and Analysis Program) and its upcoming launch in early 2022, the data product validation activities have been intensified. As part of the science preparation and mission support project led by the German Research Center (GFZ) Potsdam, the overall quality of the official EnMAP products has to be accessed and evaluated independently from the data quality control activities performed by the Ground Segment at DLR EOC. Therefore, the radiometric, spectral, reflective, geometric and general quality of the three official EnMAP products (L1B, L1C and L2A) has to be validated during the commissioning and nominal phase.This paper presents an update of the data product validation activities, an in-depth insight into the overall approach and into specifically designed methods described in the EnMAP Product Validation Plan.

The advent of up-to-date hyperspectral technologies, and their increasing performance both spectrally and spatially, allows for new and exciting studies and practical applications in agriculture (soils and crops) and vegetation mapping and monitoring atregional (satellite platforms) andwithin-field (airplanes, drones and ground-based platforms) scales. Within this context, the special issue has included eleven international research studies using different hyperspectral datasets (from the Visible to the Shortwave Infrared spectral region) for agricultural soil, crop and vegetation modelling, mapping, and monitoring. Different classification methods (Support Vector Machine, Random Forest, Artificial Neural Network, Decision Tree) and crop canopy/leaf biophysical parameters (e.g., chlorophyll content) estimation methods (partial least squares and multiple linear regressions) have been evaluated. Further, drone-based hyperspectral mapping by combining bidirectional reflectance distribution function (BRDF) model for multi-angle remote sensing and object-oriented classification methods are also examined. A review article on the recent advances of hyperspectral imaging technology and applications in agriculture is also included in this issue. The special issue is intended to help researchers and farmers involved in precision agriculture technology and practices to a better comprehension of strengths and limitations of the application of hyperspectral measurements for agriculture and vegetation monitoring. The studies published herein can be used by the agriculture and vegetation research and management communities to improve the characterization and evaluation of biophysical variables and processes, as well as for a more accurate prediction of plant nutrient using existing and forthcoming hyperspectral remote sensing technologies.

Tellme is a new user research tool that connects qualitative user feedback to quantitative product data in business-to-business environments. The concept consists of a mobile application and a dashboard. Through the mobile application qualitative user feedback is obtained during prolonged use of products. This feedback is connected to the quantitative product data of these products (data logging) and shown real-time to the design and development team via a monitoring dashboard. As such the development team can not only empathize with the users they are designing for, but also immediately address the obtained feedback during development. This increases the probability that the end- product will fulfil the end-user’s needs and expectations. In this paper we will first discuss our motivation to develop Tellme. We will give an overview of existing tools and methods related to Tellme. We will introduce Tellme and report a case where Tellme was used. We will conclude the paper by discussing its use in new product development processes.

Taking photographs with a commercially available digital camera is an efficient and objective method for determining the green fractional vegetation cover (FVC) for field validation of satellite products. However, classifying leaves under shadows in processing digital images remains challenging and results in classification errors. To address this problem, an automatic shadow-resistant algorithm in the Commission Internationale d’Eclairage L*a*b* color space (SHAR-LABFVC) based on a documented FVC estimation algorithm (LABFVC) is proposed in this paper. The hue saturation intensity (HSI) is introduced in SHAR-LABFVC to enhance the brightness of shaded parts of the image. The lognormal distribution is used to fit the frequency of vegetation greenness and to classify vegetation and the background. Real and synthesized images are used for evaluation, and the results are in good agreement with the visual interpretation, particularly when the FVC is high and the shadows are deep, indicating that SHAR-LABFVC is shadow resistant. Without specific improvements to reduce the shadow effect, the underestimation of FVC can be up to 0.2 in the flourishing period of vegetation at a scale of 10 m. Therefore, the proposed algorithm is expected to improve the validation accuracy of remote sensing products.

Fractional vegetation cover (FVC) is one of the most important criteria for surface vegetation status. This criterion corresponds to the complement of gap fraction unity at the nadir direction and accounts for the amount of horizontal vegetation distribution. This study aims to directly validate the accuracy of FVC products over crops at coarse resolutions (1 km) by employing field measurements and high-resolution data. The study area was within an oasis in the Heihe Basin, Northwest China, where the Heihe Watershed Allied Telemetry Experimental Research was conducted. Reference FVC was generated through upscaling, which fitted field-measured data with spaceborne and airborne data to retrieve high-resolution FVC, and then high-resolution FVC was aggregated with a coarse scale. The fraction of green vegetation cover product (i.e., GEOV1 FVC) of SPOT/VEGETATION data taken during the GEOLAND2 project was compared with reference data. GEOV1 FVC was generally overestimated for crops in the study area compared with our estimates. Reference FVC exhibits a systematic uncertainty, and GEOV1 can overestimate FVC by up to 0.20. This finding indicates the necessity of reanalyzing and improving GEOV1 FVC over croplands.

A literatura sobre o processo de desenvolvimento de produtos (PDP) dedica pouca atenção à etapa de preparação dos meios de manufatura. Em certos produtos, porém, o diferencial tecnológico está justamente no processo de fabricação. É o caso de bens de consumo que se caracterizam pela produção em alto volume, predominando processos produtivos com elevado nível de automação. Este trabalho apresenta um estudo de caso em um produtor de bens de consumo para higiene pessoal, cuja característica principal é o volume de produção elevado. Partindo de uma análise detalhada do PDP, demonstram-se a importância desta etapa, as dificuldades enfrentadas pela empresa e questões de pesquisa relevantes. A análise contemplou a modelagem do processo de negócio, entrevistas com os principais atores e análise documental. Além de apresentar e discutir a experiência da empresa estudada, descrevem-se lacunas importantes na teoria gestão do desenvolvimento de produtos e recomendações para pesquisas futuras. The new product development process (PDP) literature doesn't give significant focus on manufacturing process specification and validation. Nevertheless, in some areas this subject is one of the main competitive advantage sources. The consumer goods industry that's related with high production level is an example. This paper presents a case study about an especific consumer goods producer from personnel higienic segment. It demonstrates the importance of this product development phase, the barriers, and the theoric gap, applying a business process modelling approach. The annalysis was based on the product development process model elaborated, interviews with stakeholders, documental analysis and participant observation. Besides presenting and discussing this enterprise experience, the paper brings an actual theory annalysis and future research statements.

A literatura sobre o processo de desenvolvimento de produtos (PDP) dedica pouca atenção à etapa de preparação dos meios de manufatura. Em certos produtos, porém, o diferencial tecnológico está justamente no processo de fabricação. É o caso de bens de consumo que se caracterizam pela produção em alto volume, predominando processos produtivos com elevado nível de automação. Este trabalho apresenta um estudo de caso em um produtor de bens de consumo para higiene pessoal, cuja característica principal é o volume de produção elevado. Partindo de uma análise detalhada do PDP, demonstram-se a importância desta etapa, as dificuldades enfrentadas pela empresa e questões de pesquisa relevantes. A análise contemplou a modelagem do processo de negócio, entrevistas com os principais atores e análise documental. Além de apresentar e discutir a experiência da empresa estudada, descrevem-se lacunas importantes na teoria gestão do desenvolvimento de produtos e recomendações para pesquisas futuras.The new product development process (PDP) literature doesn't give significant focus on manufacturing process specification and validation. Nevertheless, in some areas this subject is one of the main competitive advantage sources. The consumer goods industry that's related with high production level is an example. This paper presents a case study about an especific consumer goods producer from personnel higienic segment. It demonstrates the importance of this product development phase, the barriers, and the theoric gap, applying a business process modelling approach. The annalysis was based on the product development process model elaborated, interviews with stakeholders, documental analysis and participant observation. Besides presenting and discussing this enterprise experience, the paper brings an actual theory annalysis and future research statements.

A broad research foundation exists on Lean management in the manufacturing context. Furthermore, the implementation of Lean in product development is discussed by an increasing number of publications. Yet, little documentation of the specific application in product development testing has been published. This master thesis provides insights into the specific environment of product development testing and the application of Lean methods. Utilizing a systematic literature research, the beginning of this work elaborates principles of case study research, the context of testing as part of product development and the Lean management framework. The findings are synthesized into a priori construct for the case research. Main pillar for this construct is the value stream mapping method. It combines the analysis of the current state, the development of the future state and a strategy for the implementation of improvements. Central part of this thesis is the in-depth case study of a global operating manufacturing company in the off-highway machinery market. Three product development testing sites were visited by the author in order to apply the previously defined case study framework. Through cross case analysis common process characteristics of the current state are derived. From a micro level perspective the relations within and across the testing process are shown. Needs, values, wastes, interruptions and other process parameters are systematically analyzed; improvements are elaborated and prioritized to develop a common future state for the testing process. A partial takt time driven test process could be developed. To visualize the process task boards were introduced and the value stream map was digitalized and connected to a management information system. The systematic understanding of information needs is a major part of the future state. A possible implementation strategy is presented in this thesis.

Das Ziel der vorliegenden Arbeit ist die Erarbeitung eines Konzeptes, das wissenschaftliche Grundlagen zur Optimierung der produktionsbezogenen Produktabsicherung in der Automobilindustrie liefert. Dabei wird der Reifegrad eines Produktes als Steuergröße zur Optimierung des Absicherungsprozesses herangezogen. Dabei ist es notwendig, nicht allein den Absicherungsprozess als eigenständiges Betrachtungsobjekt zu verstehen, sondern alle relevanten Einflussfaktoren zu berücksichtigen. Daher wird als wesentliches Ordnungsschema für diese Arbeit das Engineering Information Management System (EIMS) zur strukturierten Erfassung des Kontextes von Entwicklungsprozessen definiert. Der aus der Analyse abgeleitete Handlungsbedarf lässt sich auf zwei wesentliche Handlungsfelder reduzieren. Einerseits besteht die Notwendigkeit, ein geeignetes Modell der produktionsbezogenen Produktabsicherung zu definieren, das ein bereichsübergreifendes Verständnis des Absicherungsprozesses schafft. Andererseits ist es notwendig, wirksame Stellhebel zur Optimierung des EIMS der produktionsbezogenen Produktabsicherung in der Praxis zu identifizieren. Diese beiden Handlungsfelder liefern die Motivation für das Konzept dieser Arbeit Wesentlicher Bestandteil des Konzeptes ist ein Modell, die Reifegradlandkarte, mit deren Hilfe eine Reifegrad-sensitive Prozessanalyse durchgeführt werden kann und die die Basis für die Optimierung der produktionsbezogenen Produktabsicherung liefert. Die Tragfähigkeit des Konzeptes wird anhand zweier Beispiele validiert. Die in der Reifegradlandkarte dokumentierten Zusammenhänge und Abhängigkeiten werden genutzt, um eine Methodik zur Analyse von Engineering Prozessen zu konzipieren sowie als Instrumentarium für eine reifegradsensitive Prozessanalyse und -optimierung. The main goal of this contribution is the development of a concept, which delivers the scientific basis for the optimisation of the production-oriented product validation in automotive industry. Therefore, the degree of maturity is used as a control factor for the improvement of the validation process. Thus, it is necessary to not only aiming at the validation process itself. The consideration of all relevant influencing factors in the context of this process is also re-quired. In order to acquire all of these influencing factors, an ordering scheme called Engineering Information Management System is defined. The identified needs of action can by roughly reduced upon two main fields. First, it is neces-sary to define a suitable model of the production-oriented product validation process and second it is required to identify mechanisms in order to turn the conceptual ideas included in the model into real engineering processes. Both requirements can be fulfilled by the maturity map, which represents the key contribution of this thesis. It delivers the basis for maturity-driven optimisation of engineering processes. Two applications of the maturity map are used to provide the evidence of the concept, and both have been successfully applied into practical scenarios aiming at the analysis and improvement of engineering processes.

Since the launch of MERIS on ENVISAT long term activities using vicarious calibration approaches are set in place to monitor potential drifts in calibration in the radiance products of MERIS. We are using a stable, well monitored reference calibration site (Railroad Valley, Nevada, USA) to derive calibration uncertainties of MERIS over time. We are using interpolation of uncertainties to derive a second set of uncertainties for a national data validation in the Netherlands. A satellite image derived land use map of the Netherlands (LGN4) is used to determine the largest homogeneous land use classes using a standard purity index (SPI). Potential adjacency effects are minimized using moving window filters on the pixels of the aggregated map. Multiple error propagation is being used to assess the impact of calibration accuracy on land use classification. A classification in 9 land use classes is finally performed on MERIS FR images of the Netherlands using image based spectral unmixing and matched filtering with endmembers derived from the LGN. We conclude that the classification performance may significantly be increased, when taking into account long-term vicarious calibration results.