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Graduate Course Proposal Form Submission Detail - PHA6148

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Current Status: Approved by SCNS - 2015-10-01
Campus: Tampa
Submission Type: New
Course Change Information (for course changes only):
Comments: To GC - Elective for Nanopharmacy. Restate 4b as outcomes. Updated 8/28/15. GC appd. To USF sys 8/28/15. Cleared 9/7/15; To UGS for SCNS 9/21/15. Nmbr 6450 approved as 6148 Effect 10/1/15. chged to online/face-to-face delivery 5/18/16


  1. Department and Contact Information

    Tracking Number Date & Time Submitted
    2613 2011-09-07
     
    Department College Budget Account Number
    Pharmacy - Graduate Programs RX 84080
     
    Contact Person Phone Email
    Shyam Mohapatra 8139748570 smohapat@health.usf.edu

  2. Course Information

    Prefix Number Full Title
    PHA 6148 Nanoformulations and Nanopharmaceuticals

    Is the course title variable? N
    Is a permit required for registration? Y
    Are the credit hours variable? N
    Is this course repeatable? Y
    If repeatable, how many times? 1

    Credit Hours Section Type Grading Option
    3 C - Class Lecture (Primarily) R - Regular
     
    Abbreviated Title (30 characters maximum)
    Nanoformulation & Nanopharma
     
    Course Online? Percentage Online
    C - Face-to-face (0% online) 0

    Prerequisites

    N/A

    Corequisites

    N/A

    Course Description

    Focus on developing an understanding of the fundamental properties, synthesis and characterization of nanomaterials, coupled with their applications in nanomedicine.


  3. Justification

    A. Please briefly explain why it is necessary and/or desirable to add this course.

    Needed for new program/concentration/certificate

    B. What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service?

    The purpose of this course is to provide an overview of the distinctive features of nanotechnology and their application to bio-medical problems. The course will provide essential training for new graduates in the nanotechnology and medicine arena.

    C. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times?

    No

    D. What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.)

    Terminal degree and research and teaching experience translational nanotechnology and nanomedicine


  4. Other Course Information

    A. Objectives

    To design and development of new therapeutic products.

    Review case-based studies of product development for pharmaceuticals, biologics, medical devices, and combination therapies.

    To discuss steps to biomedical product development, from conceptualization to design to manufacturing to regulatory approval and commercialization. The course will also discuss both technical and business factors that contribute to the success or failure of new biomedical products. Appropriate design of preclinical and clinical trials is also included in the course. Students gain an appreciation for emerging technologies in stem cells, gene therapy, tissue regeneration, personalized medicine, and targeted therapies. Additionally, students learn about the special challenges presented by emerging biomedical technologies. By the end of the course, each student completes a project to propose a new biomedical device and identify the regulatory strategy, technical milestones, and business milestones for the new device.

    Specific objectives include:

    • the understand the fundamentals of nanoscience,

    • the principles of nanoscale engineering,

    • recognize the various types of nanoparticles and nanoprobes,

    • understand nanomedicine (both technologies and applications); and

    • discuss integration with bioinformatics and personalized medicine.

    B. Learning Outcomes

    Students who successfully complete the course will have mastered the following competences:

    • develop a proposal for new biomedical devices including product development process for pharmaceutics/pharmeceuticals, biologics, devices, and combination therapies

    • the ability to identify the regulatory strategy, technical milestones, and business milestones for the new devices implementation including the approval process and key regulatory agencies for new drugs, biologics, devices, and drug-device combinations.

    • understand the fundamental concepts behind nanomedicine.

    • Be familiar with the application of nanomedicine in developing novel diagnostics and therapeutics

    • be able to identify the most common uses of nanomedicine as they may apply to personalized medicine

    • Students will understand the roles of preclinical development, clinical

    development, and manufacturing scale-up processes in product

    development.

    • Students will have a working understanding of the ethical, social, and cultural considerations for novel biomedical product development.

    • Students will understand emerging biomedical product categories.

    • Students will learn to analyze and critique contemporary real-world

    cases of biomedical product development.

    • students will be able to generate visionary concepts and commercialization strategies for new biomedical products.

    C. Major Topics

    Pharmaceutical production and quality assurance, a perspective of nanopharmaceuticals - from the bench to the surgical patient, Design and use of nanopharmaceuticals, and Regulation of nanopharmaceuticals and devices

    D. Textbooks

    The Handbook of Nanomedicine Nanomedicine: Design and Applications of Magnetic Nanomaterials, Nanosensors and Nanosystems

    E. Course Readings, Online Resources, and Other Purchases

    Current literature in the form of articles from appropriate nanomedicine will be utilized throughout the course. The students will need to access these for review and presentation.

    F. Student Expectations/Requirements and Grading Policy

    Final grade will be : Test scores 30% Written, Directed Research 50% Participation in Active Learning 10% Completing Peer Assessment 10%

    G. Assignments, Exams and Tests

    There will be four exams the format will be short answer

    Each student will be expected to present a summary of a recent publication in the field to the class. The choice of publication must be approved by the course director.

    Each student will be expected to present, discuss, critique and assign scientific significance to the selected paper as part of the presentation.

    All students will be expected to enter in the discussion of each paper presented. This will determine the class participation grade.

    H. Attendance Policy

    Course Attendance at First Class Meeting – Policy for Graduate Students: For structured courses, 6000 and above, the College/Campus Dean will set the first-day class attendance requirement. Check with the College for specific information. This policy is not applicable to courses in the following categories: Educational Outreach, Open University (TV), FEEDS Program, Community Experiential Learning (CEL), Cooperative Education Training, and courses that do not have regularly scheduled meeting days/times (such as, directed reading/research or study, individual research, thesis, dissertation, internship, practica, etc.). Students are responsible for dropping undesired courses in these categories by the 5th day of classes to avoid fee liability and academic penalty. (See USF Regulation – Registration - 4.0101,

    http://usfweb2.usf.edu/usfgc/ogc%20web/currentreg.htm)

    Attendance Policy for the Observance of Religious Days by Students: In accordance with Sections 1006.53 and 1001.74(10)(g) Florida Statutes and Board of Governors Regulation 6C-6.0115, the University of South Florida (University/USF) has established the following policy regarding religious observances: (http://usfweb2.usf.edu/usfgc/gc_pp/acadaf/gc10-045.htm)

    In the event of an emergency, it may be necessary for USF to suspend normal operations. During this time, USF may opt to continue delivery of instruction through methods that include but are not limited to: Blackboard, Elluminate, Skype, and email messaging and/or an alternate schedule. It’s the responsibility of the student to monitor Blackboard site for each class for course specific communication, and the main USF, College, and department websites, emails, and MoBull messages for important general information.

    I. Policy on Make-up Work

    For Documented student absence (illness) students will be allowed to makeup missing exams or presentations. Students will be required to abide by USF policy on academic integrity.

    J. Program This Course Supports

    Master of Science in Pharmaceutical Nanotechnology and Master of Science in Medical Sciences; Concentration Nanomedicine


  5. Course Concurrence Information

    N/A



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