Course Form (revised 7-2008) I. Summary of Proposed Changes Dept / Program BMED Course Title Advanced Pharmaceutics Short Title (max. 26 characters incl. spaces) Summarize the change(s) proposed Course # 632 Change title of course to “Advanced Pharmacokinetics”, change the course description, change the credits to 4 (from variable 1-3 cr), offered every fall semester (from intermittently). II. Endorsement/Approvals Complete the form and obtain signatures before submitting to Faculty Senate Office Please type / print name Signature Requestor: Erica Woodahl Phone/ email : x4129 erica.woodahl@umontana.edu Program Chair/Director: Rich Bridges Other affected programs: Dean: Date Dave Forbes III: To Add a New Course Syllabus and assessment information is required (paste syllabus into section V or attach). Course should have internal coherence and clear focus. Exact entry to appear in the next catalog (Specify course abbreviation, level, number, title, credits, repeatability (if applicable), frequency of offering, prerequisites, and a brief description.) Justification: How does the course fit with the existing curriculum? Why is it needed? Are there curricular adjustments to accommodate teaching this course? Complete for UG courses. (UG courses should be assigned a 400 number). Describe graduate increment (Reference guidelines: http://www.umt.edu/facultysenate/Grad/UG.htm) Fees may be requested only for courses meeting specific conditions determined by the Board of Regents. Please indicate whether this course will be considered for a fee. If YES, what is the proposed amount of the fee? Justification: IV. To Delete or Change an Existing Course – check X all that apply Deletion Title Course Number Change From: Level U, UG, G To: Description Change X Change in Credits X Recent developments and emerging concepts in theoretical and experimental pharmacokinetics, pharmacogenomics, and drug disposition. Critical analysis of the current literature. From: 1-3 cr To: 4 cr Repeatability Cross Listing (primary program initiates form) YES From: To: NO Prerequisites None 1. Current course information at it appears in catalog (http://www.umt.edu/catalog) G 632 Advanced Pharmaceutics 1-3 cr. (R-6) Offered intermittently. Advanced studies of dosage formulations, biopharmaceutics, and pharmacokinetics. 3. If cross-listed course: secondary program & course number 4. Graduate increment if level of course is changed to UG. Reference guidelines at: http://www.umt.edu/facultysenate/Grad/UG.htm (syllabus required in section V) 5. Other programs affected by the change 6. Justification for proposed change Is there a fee associated with the course? 2. Full and exact entry (as proposed) No G 632 Advanced Pharmacokinetics 4 cr. Offered Fall. Recent developments and emerging concepts in theoretical and experimental pharmacokinetics, pharmacogenomics, and drug disposition. Critical analysis of the current literature. Have you reviewed the graduate increment guidelines? Please check (X) space provided. BMED632 has not been taught for many years. I am a new faculty and am restarting this class. I am substantially updating the class and integrating a lecture component with a discussion component, which will focus on experimental methods and current literature analyses. The current title (Advanced Pharmaceutics) is not reflective of what my revamped course will cover. Pharmaceutics is a broad topic encompassing dosage formulations, physiochemical properties of a drug, biopharmaceutics, and drug delivery (as well as pharmacokinetics). These other topics besides pharmacokinetics will not be covered in this course and therefore the current title is misleading. Pharmaceutics is also an antiquated term and does not reflect the innovation and current research focus that Pharmacokinetics encompasses. The change to a title of “Advanced Pharmacokinetics” is therefore necessary for this redesigned and updated course. Advanced Pharmacokinetics will cover all aspects of drug disposition, which includes absorption, distribution, metabolism, and elimination of a drug, as well as incorporating new and innovative areas of research in drug transporters and pharmacogenomics. I am also requesting a change of credit number. Previously the class was offered intermittently for 1-3 credits, based on graduate student interest and enrollment. My updated class will be structured with consistent class times every week: 3 credit hours will be in class lecture format and the 4th credit will be a separate discussion section meeting time focusing on research and current literature. The class will meet in the fall semester to coincide with the class BMED 432, which will comprise the lecture component. The change in title for BMED 632 will also match a change in the course name for BMED 432 that I will be proposing in the fall 2009 - from “Biopharmaceutics and Pharmacokinetics” to “Clinical Pharmacokinetics”. V. Syllabus/Assessment Information Required for new courses and course change from U to UG. Paste syllabus in field below or attach and send digital copy with form. VI Department Summary (Required if several forms are submitted) In a separate document list course number, title, and proposed change for all proposals. VII Copies and Electronic Submission. After approval, submit original, one copy, summary of proposals and electronic file to the Faculty Senate Office, UH 221, camie.foos@mso.umt.edu. Advanced Pharmacokinetics BMED 695 Section 01 Fall 2009 Erica Woodahl, Ph.D. – Course Coordinator Office: SB 477B Phone: x4129 email: erica.woodahl@umontana.edu Lecturers: Erica Woodahl, Ph.D. Howard Beall, Ph.D. John Gerdes, Ph.D. Mark Pershouse, Ph.D. phone: x5112 phone: x4084 phone: x4084 email: howard.beall@umontana.edu email: john.gerdes@umontana.edu email: mark.pershouse@umontana.edu Course Time and Location: Tuesdays and Thursdays 1:40-3:00p, SB 169 – in conjunction with BMED 432 Wednesdays 2-4p Office Hours: Arranged by each faculty member Course Description: Pharmacokinetics describes the time course of a drug in the body and is the critical piece in determining drug design and dosing regimens. This course provides the basic principles of pharmacokinetics including the processes of ADME (Absorption, Distribution, Metabolism, and Elimination) and their application to the clinical setting, including single-dose intravenous and oral kinetics, multiple dosing, nonlinear pharmacokinetics, metabolite kinetics, pharmacogenetics, role of disease in drug clearance and dose requirements, and kinetics of drug-drug interactions. In addition, this course will provide a more in advanced discussion of the application of pharmacokinetics in research and drug development. Required Textbooks: Tozer and Rowland. Introduction to Pharmacokinetics and Pharmacodynamics. Shargel, Wu-Pong, and Yu, Applied Biopharmaceutics and Pharmacokinetics. (5th edition) Exams: Exam #1 Exam #2 Exam #3 Final Written Exam Final Oral Exam 20% 20% 20% 20% 20% Lectures 9/1 – 9/22 Lectures 9/29 – 10/15 Lectures 10/20 – 11/17 ~60% new; ~40% cumulative Cumulative Exams will cover materials from lectures, and assigned readings. Exams will use multiple choice, calculations, and short answer formats. Calculations of pharmacokinetic parameters and dosage regimens will be required. A calculator is required. Examinations will be administered in class during the allotted time. Students are expected to take all exams at the scheduled time. If you are unable to take an exam due to sudden illness or family emergency, notify Erica Woodahl as soon as possible to schedule a make-up exam. If you have a question regarding the grading of your exam, an appointment must be scheduled within 10 days following the return of your exam. After that time, adjustments to your grade will not be made. Grading Scale: The plus/minus grading system will be used: A- = 90%, B- = 80%, C- = 70%, D- = 65% Expectations for Academic Honesty at UM: All students must practice academic honesty. Academic misconduct is subject to an academic penalty by the course instructor and/or a disciplinary sanction by the University. All students need to be familiar with the Student Conduct Code: http://www.umt.edu/SA/VPSA/index.cfm/page/1321 Expectations for Student Behavior: Students are expected to arrive on time for class and workshops. Respectful and courteous behavior to your classmates, teaching assistants, and instructor will be expected at al times. PLEASE turn off all cell phones and other electronic devices that may distract you and others prior to entering class. LECTURE SCHEDULE DATE TOPICS READINGS INSTRUCTOR WEEK 1 T (9/1) Introduction to Pharmacokinetics and IV Kinetics Chapters 1 and 2 EW WEEK 2 Th (9/3) T (9/8) Chapter 5 Chapter 5 EW EW WEEK 3 Th (9/10) T (9/15) Chapter 5 Chapter 5 EW/JG EW WEEK 4 Th (9/17) T (9/22) Clearance Concepts Chapter 5 Chapter 5 EW EW WEEK 5 Th (9/24) T (9/29) EXAM #1 Drug Absorption and Bioavailability Chapters 4 and 6 EW/JG WEEK 6 Th (10/1) T (10/6) Oral Kinetics Dosing Regimens I Chapter 6 Chapters 8, 9, and 10 EW EW WEEK 7 Th (10/8) T (10/13) Dosing Regimens II Dosing Regimens III Chapters 8, 9, and Chapters 8, 9, and 10 10 EW EW Th (10/15) T (10/20) Dosing Regimens IV WEEK 8 Chapters 8, 9, and Chapters 3 and 7 10 EW JG WEEK 9 Th (10/22) T (10/27) Chapter 4 EW WEEK 10 Th (10/29) T (11/3) Chapter 4 Chapter 11 and 12 EW EW Th (11/5) T (11/10) Chapter 11 and 12 EW WEEK 11 EW EW WEEK 12 Th (11/12) T (11/17) Chapter 11 and 12 Chapter 11 and 12 Chapter 11 and 12 EW WEEK 13 Th (11/19) T (11/24) EXAM #3 Pharmacokinetic Imaging WEEK 14 Th (11/26) T (12/1) Thanksgiving – NO CLASS WEEK 15 Th (12/3) T (12/8) FINAL Elimination Half-Life Volume of Distribution; Plasma and Tissue 2 compartment models Binding Renal Clearance and Urinary Kinetics Clearance Concepts Pharmacokinetic-Pharmacodynamic Relationships EXAM #2 Drug Transporters Drug Transporters Pharmacogenomics Pharmacogenomics Physiologic Factors on Pharmacokinetics Physiologic Factors on Pharmacokinetics Physiologic Factors on Pharmacokinetics JG EW Nonlinear Pharmacokinetics Metabolite Kinetics Drug Interactions Th (12/10) Drug Interactions Th (12/17) FINAL EXAM 1:10-3:10p SB 169 Chapter 11 and 12 EW EW Chapter 11 and 12 EW DISCUSSION SCHEDULE DATE WEEK 1 Wed (9/2) TOPICS INSTRUCTOR Introduction: the ADME Concept and Mathematical Principles EW Readings: Shargel, Ch. 1 and 2 WEEK 2 Wed (9/9) Physiology Processes in Pharmacokinetics EW/MP Readings: Handout from A&P text WEEK 3 Wed (9/16) Intravenous Dosing: Disposition based on plasma data EW Readings: Shargel, Ch. 3 WEEK 4 Wed (9/23) Intravenous Dosing: Compartmental models EW/JG Readings: Shargel, Ch. 4 WEEK 5 Wed (9/30) Extravascular Dosing and Bioavailability EW Readings: Shargel, Ch. 7, 11 (pp 332-338), 13, and 15 (453-465) WEEK 6 Wed (10/7) Clearance Concepts EW Readings: Shargel, Ch. 6 and 11 (pp 338-348) WEEK 7 Wed (10/14) Clearance Concepts EW Readings: Shargel, Ch. 6 and 11 (pp 338-348) WEEK 8 Wed (10/21) pH/pKa Relationships in Drug Absorption and Distribution HB Readings: Tozer, Appendix B; and Shargel, Ch. 13 WEEK 9 Wed (10/28) Plasma Protein Binding and Distribution EW Readings: Shargel, Ch. 10 WEEK 10 Wed (11/4) Drug-Metabolizing Enzymes EW/JG Readings: Shargel, Ch. 11 (pp 303-332) WEEK 11 Wed (11/11) Drug Transporters EW Readings: Shargel, Ch. 11 and 13 WEEK 12 Wed (11/18) Pharmacogenomics Readings: Shargel, Ch. 12 WEEK 13 Wed (11/25) Thanksgiving – No Class EW WEEK 14 Wed (12/2) Enzyme Kinetics and Nonlinear Kinetics EW Readings: Shargel, Ch. 9 WEEK 15 Wed (12/9) Drug Interactions Readings: Shargel, Ch. 11 (pp 308-312) and 20 (pp 642-650) FINAL TBA ORAL EXAM EW