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所在平台: Udemy |
课程主页: https://www.udemy.com/course/design-of-experiement-doe-in-pharmaceutical-development/
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课程名称:(DOE)制药开发中的实验设计 课程概述: 如果您正在寻找制药开发中的实验设计(DOE)课程,那么这个课程非常适合您,费用也很低。您将学习设计空间的创建和实验的整体设计,同时需要具备一定的风险评估和关键参数评估知识。虽然市面上有许多书籍可供参考,但研究相关领域的论文能更好地帮助您了解。许多软件如JMP和Sigma Plot提供免费试用,您可以通过简单的点击学习创建设计空间。 在20世纪初,罗纳德·费舍尔(Sir Ronald Fisher)首次引入了在研究规划阶段应用统计分析的概念。通过在设计阶段应用统计思维,可以通过采用德明的深邃知识方法,包括系统思维、变异理解、知识理论和心理学,将质量内置于产品中。与其他行业相比,制药行业在采用这些理念方面略显滞后,过于关注重磅药物,而配方开发主要依赖逐一因子研究(OFAT),未能实施设计质量(QbD)和现代工程制造方法。在各种数学建模方法中,实验设计(DoE)被广泛应用于QbD的实施,无论是在研究还是工业领域。在QbD中,对产品和过程的理解是确保最终产品质量的关键。通过建立 Inputs 和 Outputs 之间的模型来理解过程。关键过程参数(CPPs)和材料属性(CMAs)与关键质量属性(CQAs)之间的数学关系定义了设计空间。因此,过程理解得以充分保证,并合理地导向满足质量目标产品特征(QTPP)的最终产品。 本课程的目标是为参与者提供进行有效和高效实验所需的分析工具和方法,涵盖多个主题,如实验设计简介、实验规划与实施、数据分析案例研究、设计矩阵及计算矩阵、主效果和交互作用效果分析等。学员将掌握如何开发预测模型以解释过程/产品行为、验证模型、优化响应和应用分数因子设计等内容。 课程内容包括: 1. 实验设计简介 2. DOE定义 3. 顺序实验 4. DOE常见陷阱 5. 实验规划与实施 6. 实验分析 7. 案例研究 8. 双水平因子设计 9. 数学模型的开发 10. 最优响应的优化 11. 分数因子设计 12. 响应曲面设计简介 通过这一课程,学员不仅能获得坚实的理论基础和实用的分析技能,还能通过实践项目,设计实验、分析结果并应用模型开发最佳解决方案。期待在课堂上见到您!
If you are looking for DOE for Pharmaceutical Development course so this is for you with cheap cost. To learn design space creation and over all design of experiment, you also need some knowledge of Risk assessment and critical parameter assessment. There are plenty of books available for this topic but its better to go through research papers related to specific field of interest. That will give you a better perspective of it.Alos there are plenty of softwares like JMP and sigma plot which offer a free trial where you can learn to creat Design space with simple clicks.At the beginning of the twentieth century, Sir Ronald Fisher introduced the concept of applying statistical analysis during the planning stages of research rather than at the end of experimentation. When statistical thinking is applied from the design phase, it enables to build quality into the product, by adopting Deming's profound knowledge approach, comprising system thinking, variation understanding, theory of knowledge, and psychology. The pharmaceutical industry was late in adopting these paradigms, compared to other sectors. It heavily focused on blockbuster drugs, while formulation development was mainly performed by One Factor At a Time (OFAT) studies, rather than implementing Quality by Design (QbD) and modern engineering-based manufacturing methodologies. Among various mathematical modeling approaches, Design of Experiments (DoE) is extensively used for the implementation of QbD in both research and industrial settings. In QbD, product and process understanding is the key enabler of assuring quality in the final product. Knowledge is achieved by establishing models correlating the inputs with the outputs of the process. The mathematical relationships of the Critical Process Parameters (CPPs) and Material Attributes (CMAs) with the Critical Quality Attributes (CQAs) define the design space. Consequently, process understanding is well assured and rationally leads to a final product meeting the Quality Target Product Profile (QTPP). This review illustrates the principles of quality theory through the work of major contributors, the evolution of the QbD approach and the statistical toolset for its implementation. As such, DoE is presented in detail since it represents the first choice for rational pharmaceutical development.Keywords: Experimental design; design space; factorial designs; mixture designs; pharmaceutical development; process knowledge; statistical thinking, Complete DoE, Types of Designs, OFAT, Plackett burman, Central Composite, Box-Behnken Designs, Surface Response CurveThe objective of Design of Experiments Training is to provide participants with the analytical tools and methods necessary to:Plan and conduct experiments in an effective and efficient mannerIdentify and interpret significant factor effects and 2-factor interactionsDevelop predictive models to explain process/product behaviorCheck models for validityApply very efficient fractional factorial designs in screening experimentsHandle variable, proportion, and variance responsesAvoid common misapplications of DOE in practiceParticipants gain a solid understanding of important concepts and methods to develop predictive models that allow the optimization of product designs or manufacturing processes. Many practical examples are presented to illustrate the application of technical concepts. Participants also get a chance to apply their knowledge by designing an experiment, analyzing the results, and utilizing the model(s) to develop optimal solutions. Minitab or other statistical software is utilized in the class.CONTENT of courseIntroduction to Experimental DesignWhat is DOE?DefinitionsSequential ExperimentationWhen to use DOECommon Pitfalls in DOEA Guide to ExperimentationPlanning an ExperimentImplementing an ExperimentAnalyzing an ExperimentCase StudiesTwo Level Factorial DesignsDesign Matrix and Calculation MatrixCalculation of Main & Interaction EffectsInterpreting EffectsUsing Center PointsIdentifying Significant EffectsVariable & Attribute ResponsesDescribing Insignificant Location EffectsDetermining which effects are statistically significantAnalyzing Replicated and Non-replicated DesignsDeveloping Mathematical ModelsDeveloping First Order ModelsResiduals /Model ValidationOptimizing ResponsesFractional Factorial Designs (Screening)Structure of the DesignsIdentifying an "Optimal" FractionConfounding/AliasingResolutionAnalysis of Fractional FactorialsOther DesignsProportion & Variance ResponsesSample Sizes for Proportion ResponseIdentifying Significant Proportion EffectsHandling Variance ResponsesIntro to Response Surface DesignsCentral Composite DesignsBox-Behnken DesignsOptimizing several characteristics simultaneouslyDOE Projects (Project Teams)Planning the DOE(s)ConductingAnalysisNext StepsRecently, DoE has been used in the rational development and optimization of analytical methods. Culture media composition, mobile phase composition, flow rate, time of incubation are examples of input factors (independent variables) that may the screened and optimized using DoE.Look for course description..look for see you in the class....