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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmaceutical-bioavailabilitybioequivalence-study-babe/
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**课程名称：** 药物临床生物等效性研究（BA/BE）课程 **课程概述：** 本课程深入探讨药物开发中至关重要的生物等效性（BE）研究。生物等效性研究的核心在于监测药物给药后的药代动力学（PK）和药效动力学（PD）参数。 * **生物利用度（BA）：** 定义为未改变的活性物质被吸收并进入体循环的速率和程度。理解生物利用度是药物开发的基础，它对generic药物的注册申报也至关重要。 * **生物等效性（BE）：** 当generic药物与原研药在生物利用度上没有显著差异时，即认为它们是生物等效的。 通过互动环节和多个案例研究，本课程将全面评估BA/BE的各个方面，包括： * **法规要求：** 了解相关的法规和指南。 * **研究方案设计：** 学习不同类型的BA/BE研究方案。 * **生物分析：** 掌握生物样本的分析方法。 * **统计分析：** 学习如何进行BA/BE数据的统计分析。 * **报告撰写：** 了解如何撰写规范的BA/BE研究报告。 * **Biowaiver（豁免）：** 探讨biowaiver的关键方面，包括监管障碍、类型和所需数据，以期节省时间和成本。 **课程收益：** 完成本课程后，您将能够： * **设计研究：** 能够设计新药或新器械的研究，以确定其与现有疗法在统计学上是否等效。 * **符合法规：** 按照监管要求设计研究，并选择合适的数据分析方法。 * **剂量-反应分析：** 能够拟合统计模型，量化药物剂量与患者平均反应之间的可靠关系。 * **掌握核心概念：** 学习生物等效性研究的基本概念，包括生物利用度与生物等效性、研究设计类型、generic药物与品牌药物的等效性标准和考量。 * **分析能力：** 能够进行PK分析（时间-浓度数据）、剂量-反应分析，并能够为平行设计和交叉设计指定生物等效性方案。 * **临床实践：** 能够审阅实际临床试验，识别终点、研究问题和使用的统计方法。 **适合人群：** * 药学文凭学生/教授 * 药学专业学生 * 药物研究人员、投资者、医生 * 医疗专业人士 * 负责设计、实施或分析临床试验的分析师
Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs.Bioavailability & BioequivalenceBioavailability (BA) is defined as the rate and extent to which the unchanged active substance is absorbed and becomes available in the systemic circulation. Understanding bioavailability is essential during drug development as it is one of the fundamental properties of drug formulation. Information on bioavailability is also used to determine bioequivalence (BE) when submitting a generic dossier.Through interactive sessions and multiple case studies, this course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting. Once completed you will have a solid understanding of bioavailability, supporting you in drug development. You will also have the confidence to develop and implement your own bioequivalence studies to ensure speedy generic approval.The course will also examine key aspects of biowaivers such as the regulatory hurdles, types of biowaivers and data needed so you can save money and time with fast biowaiver applications.Benefits of Course:After taking this course, students will be able to specify the design of a new drug or new device study with the goal of establishing whether the new protocol is statistically equivalent to an existing therapy. You will learn how to design a study in accordance with regulatory requirements, as well as appropriate methods for analyzing data. You will be able to fit statistical models to dose-response data with the goal of quantifying a reliable relationship between drug dosage and average patient response.Basic concepts for Bioequivalence studyBioavailability & bioequivalence Types of Study DesignsHow Generic medicine becomes Bioequivalent with Branded MedicinesCriteria and considerations for BA/BE StudyConduct PK analysis of time-concentration dataConduct dose-response analysisSpecify bioequivalence designs for parallel and crossover designsReview actual clinical trials and identify end point, question of interest, statistical method usedWho Should Take This CourseDiploma Pharmacy Students/ProfessorPharmacy StudentsPharmaceutical researcher, Investor, DoctorsMedical ProfessionalAnalysts responsible for designing, implementing or analyzing clinical trials.
