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所在平台: Udemy |
课程主页: https://www.udemy.com/course/bioavailability-ba-bioequivalency-be-in-pharma/
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本Coursera课程“药物生物利用度（BA）/生物等效性（BE）”深入探讨了药物开发中的关键概念。课程涵盖了生物利用度（BA）——即活性成分从药物制剂中吸收并到达作用部位的速率和程度，以及它如何用于估算吸收分数、药物分布、清除以及开发治疗剂量方案。 课程重点介绍了仿制药的开发，解释了仿制药与原研药在活性药物成分（API）和剂型上的相同性，以及如何通过生物等效性（BE）研究来确定仿制药是否与原研药在相同剂量和相似条件下具有可比的生物利用度。 具体内容包括： * **基础定义**：API、成品制剂（FPP）、参比制剂（RLD）、仿制药、药物扩散、生物药剂学分类系统（BCS）、药物替代品、药物等效品、药物生物等效性（治疗等效性）。 * **生物利用度（BA）**：BA的介绍、原因。 * **生物等效性（BE）**：BE的介绍、原因，以及体外和体内BE研究。 * **BA与BE要素**：包括BA、BE、ADME（吸收、分布、代谢、排泄）、药代动力学（PK）参数（如AUC、Cmax、Tmax）和BE标准。 * **BA与BE研究**：BE研究设计（交叉设计，平行设计），研究设计比较，研究人群（受试者数量、健康状况、患者受试者），研究条件，采样时间。 * **Biowaiver（生物豁免）**：Biowaiver的定义、通用标准以及针对不同剂型（如口溶片、口服溶液、注射溶液、乳剂）的特定Biowaiver标准。 * **结论** 本课程为理解药物评价、仿制药审批以及确保药物治疗安全性和有效性的基本原理提供了全面的视角。
Bioavailability (BA) is defined as the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. Bioavailability studies provide an estimate of the fraction of drug absorbed as well as drug distribution and elimination. Bioavailability studies are also used to develop a therapeutic dosage regimen.Generic drug products are drug products containing the same active pharmaceutical drug ingredient (API) in the same dosage form as that marketed by the innovator (brand) company. A generic drug product is considered a therapeutic equivalent to the innovator (brand) drug product if it meets the regulatory requirements for therapeutic equivalence. In generic drug development, bioequivalence studies are used to determine bioequivalence.Bioequivalence (BE) is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.Bioequivalent drug products are pharmaceutical equivalent or pharmaceutical alternative products that display comparable bioavailability to a reference drug product when studied under similar experimental conditions.The test drug product (generic product) is considered bioequivalent to the reference drug product if the rate and extent of absorption of the test drug does not show a significant difference from the rate and extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions.BIOAVAILABILITY & BIOEQUIVALENCE COURSE CONTENT1 INTRODUCTION 2 INTRODUCTION TO BA/BE 2.1. Basic Definitions-1 2.1.1. Active Pharmaceutical Ingredient (API) 2.1.2. Finished Pharmaceutical Product (FPP) 2.2. Basic Definitions-2 2.2.1. Reference Listed Drug (RLD) 2.2.2. Generic (Multisource) Pharmaceutical Products 2.2.3. Generic Drug & Reference Listed Drug (RLD) 2.3. Basic Definitions-3 2.3.1. Pharmaceutical Alternatives 2.3.2. Pharmaceutical Equivalence 2.4. Basic Definitions-4 2.4.1. Pharmaceutical Bioequivalency (Therapeutic Equivalency) 2.5. Basic Definitions-5 2.5.1. Drug Diffusion & Biopharmaceutics Classification System (BCS) 3 BIOAVAILABILITY 3.1. Introduction to Bioavailability 3.2. Reasons for Bioavailability (BA) 4 BIOEQUIVALENCY 4.1. Introduction to Bioequivalency (BE) 4.2. Reasons for Bioequivalency (BE) 4.3. In-Vitro and In-Vivo Studies for Bioequivalency (BE) 5 ELEMENTS OF BA & BE 5.1. Elements of BA & BE - 1 5.1.1. Bioavailability (BA) 5.1.2. Bioequivalency (BE) 5.1.3. ADME 5.1.4. Pharmacokinetics (PK) & ADME 5.2. Elements of BA & BE - 2 5.2.1. Pharmacokinetics (PK) Parameters 5.2.2. Plasma Concentration & Time Curve 5.2.3. The Area Under the Concentration Time Curve (AUC) 5.2.4. The Maximum Plasma Concentration (Cmax) 5.2.5. The Time to Reach Cmax (Tmax) 5.2.6. Bioequivalency (BE) Criteria 6 BA & BE STUDIES 6.1. Bioequivalency (BE) Study 6.2. Bioequivalency (BE) Study Design 6.3. Cross-over Study Design 6.4. Parallel Study Design 6.5. Comparison of Cross-over Study Design and Parallel Study Design 6.6. Study Population (Subjects) 6.6.1. Study Population (Number of Subjects) 6.6.2. Study Population (Health Conditions of Subjects) 6.6.3. Study Population (Study with Patient Subjects)6.7. Study Conditions 6.8. Sampling Times 7 BIOWAIVER 7.1. Biowaiver 7.2. General Biowaiver Criteria 7.3. Biowaiver Criteria-1 7.4. Biowaiver Criteria-2 7.5. Biowaiver Criteria-3 7.6. General Biowaiver Criteria for Other Dosage Forms 7.7. General Biowaiver Criteria for Orodispersable Tablets 7.8. General Biowaiver Criteria for Oral Solutions 7.9. General Biowaiver Criteria for Parenteral Solutions 7.10. General Biowaiver Criteria for Emultions 8 CONCLUSION8.1.Conclusion
