MPS5104
Drug formulation, clinical trials and registration
基本信息
| 学分 | 6 credit points |
|---|---|
| 开课学期 | First semester |
| 校区 | Malaysia |
| 考核构成 | Clinical Trials Report — 20% Online quizzes — 40% Medicine Registration Report — 20% Formulation Report — 20% |
开课安排1 条
| 教学期 | 授课方式 | 状态 |
|---|---|---|
| First semester | Teaching activities are on-campus (ON-CAMPUS) | 开课 |
以上为该校区在官方资料中登记的全部开课安排，不是汇总。同一门课可能在多个 教学期开课，也可能不同教学期的授课方式不同。
课程简介
This unit will take you through the process of developing a drug candidate into a registered pharmaceutical product and beyond. Once a lead candidate has been identified, the drug development pathway encompasses drug formulation; clinical trial regulation and design; intellectual property and marketing considerations. You will be introduced to the regulatory and commercial requirements of drug registration and analyse real-life drug development cases.
Upon completing this unit, you will have gained an appreciation of the interdependent components of the drug development and registration process.
以上为 Monash Handbook 的官方原文，版权属 Monash University，此处按本站要求转载并标注出处： 官方页面 ↗
学习成果7 条
官方原文（Learning outcomes），版权属 Monash University。
- ULO1 Compare and contrast properties and characteristics of selected essential pharmaceutical forms
- ULO2 Suggest and evaluate formulation approaches for drugs based on their physicochemical properties, physiological factors and medical considerations
- ULO3 Rationally choose and defend a pharmaceutical form to create a medicine
- ULO4 Explain the scientific and regulatory stages involved in taking a drug candidate to a registered pharmaceutical product
- ULO5 Differentiate between the phases of a clinical trial, and use exemplars to describe outcomes that indicate success or failure through each phase
- ULO6 Define the factors that underpin commercial success of a medicine, including the importance of intellectual property and marketing considerations, and surveillance of consumer outcomes
- ULO7 Use effective teamwork and collaborative skills to write effective formulation, clinical trials and medicine registration reports that follow conventions in the discipline
教学方式与预期工作量
教学方式
Peer assisted learning
Case-based teaching
Enquiry-based learning
Simulation or virtual practice
Active learning
预期工作量
• Twelve 2-hour online modules
• Nine 2-hour workshops
• Three 1.5-hour in-class assessments
• 60 hours of team-based collaborative work
• 37 hours independent study
官方原文，版权属 Monash University。
先修 / 同修要求
官方资料未列出该课程的先修要求。
先修链路
官方资料未列出该课程的先修要求，因此没有链路可画。
属于这些学位1 个
这门课出现在下列学位的官方结构里。反过来说：如果你读的是这些学位之一，它大概率是要修的 （必修还是选修取决于它在 Part 里的位置，点进去看结构）。
数据来源
- 数据来源
- 官方网页
handbook.monash.edu ↗ - 抓取时间
- 2026-09-13
- 可信度
- 程序抓取，未人工核实
查看官方完整描述 ↗ — 事实性字段（代码、学分、教学期、授课方式、考核权重、先修/同修/互斥关系）与 课程简介、学习成果、教学方式、预期工作量均取自官方 Handbook； 正文版权属 Monash University，此处转载并逐处标注出处。
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