Course Title -Biopharmaceutics and Clinical Pharmacokinetics

Course Number - PHA - 411
Credits - 3
Course Time - Lecture Tuesday and Thursday - 8:00 to 9:15 
  SLC 166

Instructors:  Dr. Kibbe (Office SLC 323 - Phone 4274) & Dr. Foote (Office 336 Phone 4293)
Office Hours Are Posted on the Instructors door.

Course Description: Biopharmaceutics and Clinical Pharmacokinetics is designed to educate pharmacy students in the principles of pharmacokinetics and Biopharmaceutics and how they assist in dosage regimen design and therapeutic efficacy evaluations. The impact of the physical and chemical nature of the drug and dosage forms will be studied as they relate to the absorption, distribution, metabolism, and elimination. The physiology of the GI tract will be related to the absorption of oral medications. The course will also examine the controlled release dosage forms and those that use novel delivery systems to administer drugs. Some principles of medicinal chemistry will also be included in the discussions of Biopharmaceutics. The clinical pharmacokinetics of individual drugs will be examined with emphasis on clinical application based on patient clinical presentations. Case study and homework will be used were appropriate.  This course is roughly divided into three parts.  The first is Biopharmaceutics, the second basic Pharmacokinetics and the third Clinical Pharmacokinetics.

Philosophy: I believe that when the instructor talks and the student transcribes, little education is going on. However, when students and instructor work together to understand the topics both benefit from the experience. Information on this WEB site is intended to supplement the information in text and literature which you should use throughout the course. Refer to the WEB site often but do not depend on a printout to represent the entire content of the course.

YOUR RESPONSIBILITIES are to read ahead, come to class with an open mind, take part in the discussion, ask questions, challenge current thinking, have fun and develop a strategy for life-long learning.

Calculators:  Students will be required to possess a basic non-programmable, non-graphing calculator.  It will be required for examinations..

  PHA 411 will serve as a foundation course for the development of the following terminal outcomes as stated in the School of Pharmacy's Student Outcomes Document

The Nesbitt School of Pharmacy Educational Outcomes  2008 include the following which are addressed in part or in whole in this class.

1.1.1  Demonstrate skills in mathematics for accurate prescription preparation, analysis of bio-physical processes and/or socioeconomic data.

1.1.2.  Utilize concepts in biochemistry, molecular biology, pharmacology (and Anatomy and Physiology), and immunology to understand the actions and uses of current and future drugs.

1.1.3.  Demonstrate knowledge of the functional groups of drugs and other aspects of medicinal chemistry important for drug disposition and drug- target interactions.

1.1.4. Demonstrate knowledge of drug mechanisms of action and toxicities.

1.1.5.  Demonstrate knowledge of physiochemical, pharmacokinetic, and pharmacodynamic principles underlying drug disposition and elimination.

1.1.9.  Describe the regulatory process for prescription and non-prescription pharmaceuticals as well as dietary and alternative medicine products.

1.2.Determine the appropriateness of drug doses, dosage forms, routes of administration, and frequencies of administration.

1.5.3.  Calculate and interpret population and individual pharmacokinetic and pharmacodynamic data.

1.5.6.    Assess the patient for possible adverse drug reactions.

1.5.7.  Identify toxic and suboptimal drug therapy.

1.7.1.    Formulate a monitoring plan for optimizing drug safety and efficacy utilizing pharmacokinetic, pharmacogenomic and pharmacodynamic principles. 

1.7.2.  Interpret clinical lab data to monitor and adjust therapy.

1.7.3  Revise the pharmaceutical care plan as necessary.

4.5  Effectively self-assess and improve personal and professional abilities on an ongoing basis.  (Continuous Professional and Personal Development)

     Definition: The student should perform tasks that demonstrate meaningful application of
essential knowledge and skills which will be evaluated using known
     Methods: Examination questions will be used to assess some of the outcomes listed above. 
In addition homework and the three part report will be used to assess some of those outcomes. 
    The written report on the disease that is part of the course will also be used to evaluate your ability to intergrate basic information from previous classes into a therapy plan for a patient with the selected disease. It also is useful in evaluating you development of the professional skills of effective self-assessment and peer assessment.

Course Objectives

At the completion of this course the student should be able to:
1) Discuss the funtions of the human body which impact the drugs liberation from the dosage form and its subsequent adsorption, distribution, metabolism, and elimination.

2) Describe the physical properties of drugs and dosage forms which can affect the drugs liberation from the dosage form and its subsequent absorption, metabolism, distribution, and elimination.
3) Describe the concepts associated with the release of drug from complex systems such as sustained release dosage forms.
4) Discuss the mechanism of drug absorption, distribution, metabolism and excretion. (LADME/ADME System).
5) Calculate the key Pharmacokinetic parameters using blood level data obtained after drug administration by various routes.
6) Evaluate bioequivalency studies for validity of results, correctness of methodology and reliability of outcomes.
7) Discuss and apply Pharmacokinetic properties of individual drugs to specific patients
8) Understand the responsibilities of a Clinical Pharmacokinetic Service
9) Recommend a therapeutic dosage schedule, monitor the patient, follow-up and make adjustments as needed.

Course Assessment

Two Hourly Exams @ 30% each 60%
Class Participation, Homework & Special Projects 5%
Final Exam (in two Parts) 255%
 Report 10%
Total 100%

Final Course Grade Scale

90+ 4.0
85 to 89 3.5
80 to 84 3.0
75 to 79 2.5
70 to 74 2.0

<70 0.0

Attendance Policy

Attendance is expected.. The class participation portion of the grade will be negatively affected by failure to attend class.

Required Text
"Handbook of Basic Pharmacokinetics", 7th Edition by W.A. Ritschel & G.L. Kearns
Recommended or Reference Text
"Basic Clinical Pharmacokinetics" 3rd Edition  by Michael E. Winter
"Pharmaceutical Calculations" Tenth Edition by Mitchell J. Stoklosa and Howard C. Ansel
"Pharmaceutical Dosage Forms and Drug Delivery Systems" 9th Edition by
Howard C. Ansel, Nicholas G. Popovich, and Loyd V. Allen Jr.
"Applied Pharmacokinetics" 3rd Edition by Evans, Schentag & Jusko

Office Hours Dr. Kibbe's and Dr. Foote's office hours will be posted outside their office.

Some Useful web sites you should look at

1)    Khan Academy has lots of science based calculations and information from K through 12 which you might have forgotten and will find useful in some or all of your courses. 

 2)   This site has lots of pharmacy calculations which will be of help in most of your clinical classes and of some use in this class.

3 )   This site is called Basic Principles of Dose Optimization.  We will refer to this site in our discussions.  About a week or two into the course you might want to go here and try some things out.

4)   This next reference does not directly apply to this course but is worth a look if you want to understand the influences on clinical drug testing. 
Dr. Lisa Bero has a one hour presentation viewable on on Bias in Drug Trials (could also search for it on you tube).  Please give it a look.  We can discuss it in class after most of you have viewed it.

Units of Instruction for PHA 411 Fall 2015

Week Date Topics Chapters
1 September 1 & 3
LADMER, Compartment Models, Volume of Distribution, Rate Constants 
1,2, 14,15, & 16
2 September 8 & 10
Pharmacokinetics of single and multiple dose and drug clearance
21 & 22
September 15 & 17
Recycling, Urinary Excretion & AUC plus Bioavailability
17 & 18
4 September 22 & 24
Two-Compartment Model
14 & 22
September 29 & October 1
Dosage regimen design and  Dose Adjustment
First Draft of Report due to Writing center;
28 & 29
6 October 6 & 8
  Special Cases - Peds, Elderly, Obese, Nonlinear, 24 to27
7 October 13 & 15
Review of problem sets; Exam 1 on October 15th Fall Break on 15th

8 October 20 & 22
 Cell and tisue organization and absorption mechanisms pKa, Ionization & Partition Coefficient  2  to 8
9 October 27 & 29
 Biopharmaceutics & GI Tract 9 & 10
November  3 & 5

Protein Binding , Biotransformation & Drug Response Modifiers
12 & 13
11 November 10 & 12
Phrmacogenomics and 2nd Exam on the 12th
12 November 17 & 19
Introduction to Clinical Pharmacokenitics and Kidney Function

13 November  24
Aminoglycosides I  REPORT DUE TO DR. KIBBE November 24 Thanksgiving break

14 Dec 1
Aminoglycosides II

14 Dec 3

15 Dec. 8

15 Dec 10
Homework review

Link to simulation : It is often best to see pharmacokinetics in action.  The simulation at this web site will help you understand the impact of changes in parameters

 We will be calling on you to use this simulation with practice problems.  Go to it now to see what it is all about. 

Writing Assignment As part of your participation grade you are being asked to produce a report. The report is a course long project with the final report due prior to the Thanksgiving break. Drafts will also be reviewed, but they will not be graded.  The third section is intended as an aid for the pharmacist who is about to discuss the drug with the patient or care giver.

Homework The assigned homework are designed to familiarize the student with the rigors of Pharmacokinetics calculations and Clinical Pharmacokinetics. Homework assignments are to be handed in as indicated. Credit will be lost from the class participation grade for work not submitted.