166 research outputs found

    BIOLOGIC ARMAMENTARIUM IN PSORIASIS

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    Psoriasis is an autoimmune disease and further classed as a chronic inflammatory skin condition serving as global burden. Moderate to severe psoriasis can be treated with conventional therapies. Less efficacy, poor patient compliance and toxicity issues were the major problems associated with conventional therapies. The introduction of biologic therapy has great impression on psoriatic treatment duration and enhanced quality of life in psoriasis patients. The new biologic therapies are tailor made medications with goal of more specific and effective treatment; less toxicity. The biologic therapy is aimed to target antigen presentation and co-stimulation, T-cell activation and leukocyte adhesion; and pro-inflammatory cascade. They act as effective and safer substitute to traditional therapy. Secukinumab, certolizumab, itolizumab, golimumab, ustekinumab, adalimumab, infliximab etanercept, alefacept etc. are the approved biologic with global market. This review briefs about psoriasis pathogenesis, traditional treatments and biologic therapies potential

    Towards a Formal Basis for Modular Safety Cases

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    Safety assurance using argument-based safety cases is an accepted best-practice in many safety-critical sectors. Goal Structuring Notation (GSN), which is widely used for presenting safety arguments graphically, provides a notion of modular arguments to support the goal of incremental certification. Despite the efforts at standardization, GSN remains an informal notation whereas the GSN standard contains appreciable ambiguity especially concerning modular extensions. This, in turn, presents challenges when developing tools and methods to intelligently manipulate modular GSN arguments. This paper develops the elements of a theory of modular safety cases, leveraging our previous work on formalizing GSN arguments. Using example argument structures we highlight some ambiguities arising through the existing guidance, present the intuition underlying the theory, clarify syntax, and address modular arguments, contracts, well-formedness and well-scopedness of modules. Based on this theory, we have a preliminary implementation of modular arguments in our toolset, AdvoCATE

    A Formal Basis for Safety Case Patterns

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    By capturing common structures of successful arguments, safety case patterns provide an approach for reusing strategies for reasoning about safety. In the current state of the practice, patterns exist as descriptive specifications with informal semantics, which not only offer little opportunity for more sophisticated usage such as automated instantiation, composition and manipulation, but also impede standardization efforts and tool interoperability. To address these concerns, this paper gives (i) a formal definition for safety case patterns, clarifying both restrictions on the usage of multiplicity and well-founded recursion in structural abstraction, (ii) formal semantics to patterns, and (iii) a generic data model and algorithm for pattern instantiation. We illustrate our contributions by application to a new pattern, the requirements breakdown pattern, which builds upon our previous wor

    Evidence Arguments for Using Formal Methods in Software Certification

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    We describe a generic approach for automatically integrating the output generated from a formal method/tool into a software safety assurance case, as an evidence argument, by (a) encoding the underlying reasoning as a safety case pattern, and (b) instantiating it using the data produced from the method/tool. We believe this approach not only improves the trustworthiness of the evidence generated from a formal method/tool, by explicitly presenting the reasoning and mechanisms underlying its genesis, but also provides a way to gauge the suitability of the evidence in the context of the wider assurance case. We illustrate our work by application to a real example-an unmanned aircraft system- where we invoke a formal code analysis tool from its autopilot software safety case, automatically transform the verification output into an evidence argument, and then integrate it into the former

    Quantifying Assurance in Learning-enabled Systems

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    Dependability assurance of systems embedding machine learning(ML) components---so called learning-enabled systems (LESs)---is a key step for their use in safety-critical applications. In emerging standardization and guidance efforts, there is a growing consensus in the value of using assurance cases for that purpose. This paper develops a quantitative notion of assurance that an LES is dependable, as a core component of its assurance case, also extending our prior work that applied to ML components. Specifically, we characterize LES assurance in the form of assurance measures: a probabilistic quantification of confidence that an LES possesses system-level properties associated with functional capabilities and dependability attributes. We illustrate the utility of assurance measures by application to a real world autonomous aviation system, also describing their role both in i) guiding high-level, runtime risk mitigation decisions and ii) as a core component of the associated dynamic assurance case.Comment: Author's pre-print version of manuscript accepted for publication in the Proceedings of the 39th International Conference in Computer Safety, Reliability, and Security (SAFECOMP 2020

    Towards Quantification of Assurance for Learning-enabled Components

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    Perception, localization, planning, and control, high-level functions often organized in a so-called pipeline, are amongst the core building blocks of modern autonomous (ground, air, and underwater) vehicle architectures. These functions are increasingly being implemented using learning-enabled components (LECs), i.e., (software) components leveraging knowledge acquisition and learning processes such as deep learning. Providing quantified component-level assurance as part of a wider (dynamic) assurance case can be useful in supporting both pre-operational approval of LECs (e.g., by regulators), and runtime hazard mitigation, e.g., using assurance-based failover configurations. This paper develops a notion of assurance for LECs based on i) identifying the relevant dependability attributes, and ii) quantifying those attributes and the associated uncertainty, using probabilistic techniques. We give a practical grounding for our work using an example from the aviation domain: an autonomous taxiing capability for an unmanned aircraft system (UAS), focusing on the application of LECs as sensors in the perception function. We identify the applicable quantitative measures of assurance, and characterize the associated uncertainty using a non-parametric Bayesian approach, namely Gaussian process regression. We additionally discuss the relevance and contribution of LEC assurance to system-level assurance, the generalizability of our approach, and the associated challenges.Comment: 8 pp, 4 figures, Appears in the proceedings of EDCC 201

    Safety Case Patterns: Theory and Applications

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    We develop the foundations for a theory of patterns of safety case argument structures, clarifying the concepts involved in pattern specification, including choices, labeling, and well-founded recursion. We specify six new patterns in addition to those existing in the literature. We give a generic way to specify the data required to instantiate patterns and a generic algorithm for their instantiation. This generalizes earlier work on generating argument fragments from requirements tables. We describe an implementation of these concepts in AdvoCATE, the Assurance Case Automation Toolset, showing how patterns are defined and can be instantiated. In particular, we describe how our extended notion of patterns can be specified, how they can be instantiated in an interactive manner, and, finally, how they can be automatically instantiated using our algorithm

    Model-Driven Development of Safety Architectures

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    We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval
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