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 354A - Phone 4274) & Dr. Foote (Office 336 Phone 4293)
Office Hours Are Posted on the Instructors doors.

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 (during Final week)
 Report 5%
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
65 to 69
60 to 64

Competency Demonstration. 


All students must demonstrate competency in dosing a patient using applied pharmacokinetic principles.  In most cases, competency will be demonstrated when a student passes the final examination (defined as > 70%).  If a student fails that part of the exam, he/she will be given a second assessment.  This assessment must be completed within 2 weeks of the returned failed exam.  Students must demonstrate competency on this assessment or they will receive a zero for this part of the course.  A third assessment is at the discretion of the instructor.  Initial exam scores are NOT changed by the re-assessment.   When competency is demonstrated, the original score will be entered into the grade book.  Therefore, students who fail exam(s) may still fail the course, even if they successfully demonstrate competency on the second assessment.




Examination Policy


All students are expected to arrive at the exam on time.  Upon entry into the lab or classroom, there will be no talking.  All personal belongings, including backpacks and coats, must be kept behind the prescription counter or in the front of theclassroom.  Examination papers are not to be turned over until you are told to do so by the instructor. All students must check that the examination is complete and read all of the instructions. After the first student leaves the examination room, no other student will be admitted into the exam and the tardy student will receive a grade of zero for the exam.  The instructors will answer only questions related to typos or obvious errors in the examination.  In cases of unusual circumstances and you cannot take the exam as scheduled, you are to contact the appropriate instructor no later than one hour prior to the start of the exam on that day.  Make up exams are NOT a given.  In unusual circumstances, a make-up exam may only be given at the discretion of the instructional team and is not guaranteed.


During exam returns, students should remain in an area visible to the instructors.   Students will have 3 school days to review an exam after grades are made available to identify problem areas, verify grading or contest answers to questions.
Exams may not be available for student review after this time period.


                                                                                                                                                                                                                     Technical Standards


The School of Pharmacy has a technical standards document that can be found in your student handbook.  The following is an excerpt regarding requesting accommodations.  "Reasonable accommodations are services provided to individuals with disabilities that remove or lessen the effect of the disability-related barrier.  Individuals without documented disabilities are not eligible for accommodations.    Candidates with disabilities, in accordance with Wilkes University policy, and as defined by section 504 of 1973 Vocational Rehabilitation Act and the Americans with Disabilities Act of 1993, who may seek accommodations in order to meet the technical standards are encouraged to contact University College to discuss what reasonable accommodations, if any, the School of Pharmacy could make in order for the candidate to meet the standards. A student with a disability who requests accommodations will be required to submit this request in writing and provide pertinent supporting documentation in accordance with Wilkes University policies." 

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 2017

Week Date Topics Chapters
1 August 29 &  31
LADMER, Compartment Models, Volume of Distribution, Rate Constants 
1,2, 14,15, & 16
2 September 5 & 7
Pharmacokinetics of single and multiple dose and drug clearance
21 & 22
September 12 & 14 
Recycling, Urinary Excretion & AUC plus Bioavailability
17 & 18
4 September 19 & 21
Two-Compartment Model
14 & 22
September 26
Dosage regimen design and  Dose Adjustment
First Draft of Report due to Writing center;
28 & 29
6 September 28 & October 3
  Special Cases - Peds, Elderly, Obese, Nonlinear, 24 to27
7 October 10
 Exam 1 on October 10th

8 October 17 & 19
 Cell and tisue organization and absorption mechanisms pKa, Ionization & Partition Coefficient  2  to 8
9 October 24 & 26
 Biopharmaceutics & GI Tract Protein Binding , Biotransformation & Drug Response Modifiers 9, 10, 12, & 13
October 31 & November  2

Phrmacogenomics and 2nd Exam on the 2rd
11 November 7 & 9
Introduction to Clinical Pharmacokenitics and Kidney Function
12 November 14 & 16
Aminoglycosides I  & II
13 November  21 & 28
Phenytoin I  & II  REPORT DUE TO DR. KIBBE Prior to TheThanksgiving break
Please note thanksgiving break
14 November 30 & December 2

14 Dec 7

15 Dec. 9

15 TBD
Final exam as scheduled by the University

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.