项目学分:

 

 

 

 

第一年主要课程

  1. 1.Global Regulatory and Development Strategies of Drugs & Medical Devices

药品及医疗器械的全球监管与发展策略
This course provides graduate students with an overview on legal and regulatory aspects relevant to drug and medical device development. This includes intellectual properties protection, global legal and regulatory requirements, protection of human subjects, ethics in clinical research, and essential elements of management of global projects. Case studies will be included to underline how regulatory strategies impact product marketing and life cycle management. Throughout the course, students will integrate knowledge using specific industry examples with the goal to identify critical decision points in the development that impact success of a new drug/medical device on the market.
Credit Hours: 3.00

  1. 2.Discovery of Drugs and Therapeutic Biologicals

药品及生物制药的研发
This course is an introduction to the discovery and early development (ie, prior to pre-clinical) of small molecule therapeutics and biopharmaceuticals such as proteins, peptides, vaccines, cell and gene therapies, and nucleotide based products. Introductions to the major classes and categories of drugs and biological will be provided including some principles of pharmacology such as drug targets/receptorsand drug-receptor interactions. Methods and principles of drug/biologics discovery will be addressed from serendipitous observation to current approaches such as HTS, computational, combinatorial chemistry, and bioinformatics. Comparison of manufacturing methodology of drugs and biologics will be provided along with special clinical and regulatory considerations for biologic products. Additionally, emphasis will be given to major therapeutic areas (oncology, CNS, cardiovascular, Infectious Diseases/AIDS) in terms of approaches currently in use and in development along with addressing the unmet needs in each area.
CreditHours: 3.00

  1. 3.Pre-Clinical /Non-Clinical Studies for IND Approval

新药临床试验IND申报的临床前研究
The course is designed to teach students regulatory framework for the pre-clinical evaluation of the safety and efficacy of a molecular entity/lead compound identified in the drug discovery/early development phases for submission of the IND application. Major emphasis will be placed on the principles of pharmacokinetics/toxicokinetics and ADME processes (Absorption, Distribution, Metabolism and Excretion) so that safe (and efficacious) dosing regimens can be recommended for the early clinical development phases. Differences between conventional (small molecules) vs. macromolecules and biologicals will be underscored.
CreditHours: 3.00

  1. 4.Development and Manufacturing of Drug Products & Devices

 药品及医疗器械的研制
This course is designed to provide an understanding of the studies conducted in support of the development of drug product (formulation/dosage form) and medical devices necessary to seek regulatory approval. An emphasis will be placed on pre-formulation/formulation studies for optimizing lead compounds during early stages of drug development, current good manufacturing practices (cGMP) and FDA/ICH guidelines for formulation components, processes and equipment, stability testing programs and overall quality assurance. Special aspects of formulation of biologicals and medical devices will also be discussed.
CreditHours: 3.00

第二年主要课程

  1. 1.Scientific Communications and Technical Writing

科学交流与科技写作
Credit Hours: 2.00

  1. 2.Phase I/II Clinical Trials Design and Research

一期、二期临床试验设计与研究
This course will provide an understanding of the early clinical drug development activities for new chemical entities that have received IND approval. Concepts of early clinical pharmacology studies, typically conducted in a Phase I setting, such as single and multiple dose pharmacokinetics, dose escalation studies to determine the safety and tolerability of drugs, mass balance and drug metabolism studies, and bioavailability studies, will be taught. Emphasis will then be placed on Phase II clinical trials as key proof-of-concept studies, and on the dose-ranging requirements for Phase II. Trial designs, including cross-over and parallel group, will be discussed. The importance of Phase I/II trials for making dose selections for Phase III studies will be explored, as will the use of Phase II trials as a go/no-go decision point. The importance of exposure-response (PK/PD) information in guiding the go/no-go decision will also be discussed. The use of biomarkers and pharmacogenomic information in decision making will be addressed.
Credit Hours: 3.00

  1. 3.Phase III /IV Clinical Trials Design and Research

三期、四期临床试验设计与研究
The role of Phase III trials in drug development and approval.Randomized controlled trial designs and factorial designs, selection ofdose levels, management of multi-center and multi-national trials,population pharmacokinetics, choice of endpoints, surrogate endpoints,and management of milestones and metrics will be discussed.
Credit Hours: 3

  1. 4.Statistical Principles in Clinical Research

临床研究的统计学原理
The course is designed to teach the statistical principles involved in designing clinical research studies to support new drug development programs. Statistical analysis techniques commonly used will be discussed as well as the newer approaches being considered. Statistical topics addressed in regulatory guidelines will be discussed. Emphasis will be placed on the use of statistical software such as JMP. Hands on exercises using the latest version of JMP will be conducted in various classes.
Credit Level: G. Credit Hours: 3.00

  1. 5.Pharmaceutical Economics & Management

医药经济与管理学
This course will focus on management of the biotechnology,pharmaceutical and contract research industries, including funding thedrug development process, competition, business, competition,business models, intellectual property and funding of biotechnology.
Credit Hours: 3.00

  1. 6.Drug Development Project I

药物研发实验设计-1
A problem-based/hypothesis driven research project or acomprehensive evaluation of a contemporary issue in drug/devicedevelopment that demonstrates competency in multidisciplinary didacticcoursework and scientific, regulatory and business aspects of newproduct development.
Credit Hours: 3.00

  1. 7.Drug Development Project II

药物研发实验设计-2
A problem-based/hypothesis-driven research project or acomprehensive evaluation of a contemporary issue in drug/devicedevelopment that demonstrates competency in multidisciplinary didacticcoursework and scientific, regulatory and business aspects of newproduct development.
Credit Hours: 3.00

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