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所在平台: Udemy |
课程主页: https://www.udemy.com/course/statistical-evaluation-of-stability-study-in-pharmaceuticals/
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**课程名称：** 根据ICH进行的稳定性研究统计评估 **课程概述：** 本课程面向制药行业的专业人士，旨在提供稳定性研究中所需的统计学知识。课程内容涵盖基础统计学概念、稳定性数据评估方法、假设检验技术以及其他关键主题。课程设计完全符合ICH指导原则，并在课程结束时提供详细的指导原则概述。 **第一部分学习内容：** * **数据类型：** 连续数据与属性数据 * **统计学类型：** 描述性统计与推断性统计 * **假设检验：** p值、t检验、F检验、方差分析（ANOVA）、协方差分析（ANCOVA） * **回归分析：** 拟合线、相关系数（r）、决定系数（R-sq）、残差、误差 * **数据分布：** 直方图、中心极限定理、正态性 * **合并性检验：** CICS、SICS和SISS * **置信区间与预测区间** * **处理因素：** 固定效应因子与随机效应因子 * **交互作用效应与变异效应** * **超标（OOS/OOT/OOE）：** 定义与处理 * **特殊原因与普通原因** **进阶学习内容：** 完成基础知识的学习后，课程将深入探讨实际应用，包括： * **保质期确定** * **内部放行限值计算** * **Minitab结果解读** * **假设检验路线图** * **行业常见问题及解决方案** * **案例研究** * **Minitab附加功能与行业技巧** **课程价值：** 本课程的学习内容不仅能帮助您掌握稳定性研究的统计评估方法，还能广泛应用于GMP环境中日常进行的多种其他应用，为您的统计学职业生涯奠定坚实基础。
If you are a pharma professional searching for statistical knowledge to use it in your daily life, if you want to learn basic statistics, learn how to evaluate stability data, how to conduct hypothesis testing and more, this course is what you are looking for. You will get exact amount of statistical knowledge which you need in your daily work for stability study.Design of this course in fully compliant with ICH and detailed overview of guidelines will be done at the end of this course. After completing first part of this course you will learn:Data Types (Continuous and Attribute)Types of Statistics (Descriptive and Inferential)Hypothesis Testing (p-value, t-test, f-test, ANOVA, ANCOVA)Regression (Fitted Line, r, R-sq, residual, error)Distribution (Histogram, Central Limit Theorem, Normality)Poolability (CICS, SICS and SISS)Confidence and Prediction IntervalsTreatment Factors (Fixed Factor and Random Factor)Interaction Effect and Variation EffectOOS/OOT/OOE (Definition and Treatment)Special Cause and Common CauseThis is the basic knowledge that you need to start your statistical journey. After understanding these concepts, we will go to real examples, and you will learn:Shelf-life DeterminationInternal Release Limit CalculationInterpreting Minitab ResultsRoadmap for Hypothesis TestingPossible Industry Problems and Their SolutionsCase StudiesMinitab Extras Industry TipsKnowledge you gained in course will help you not only for stability study, but also for a lot of different applications done in GMP environment each day.
