File=5533_Syllabus_2015_FInal

Advanced Pharmacokinetics and Biopharmaceutics

PHAR 5533
Fall Semester, 2015
Instructors:
Thomas P. Johnston, Ph.D., R.Ph.
Professor of Pharmaceutics
Dhiren Shah, Ph.D., R.Ph.
Adjunct Professor of Pharmaceutics
Contact Information for Instructors:
Office appointments only via e-mail notification for both instructors
Location and Time:
Room 4306 NHSB

Class time: Tues and Thurs from 1:30 p.m. to 2:45 p.m.

Course Objectives:
1.
2.
3.
4.

To provide an expanded and more in-depth study of pharmacokinetics

To be able to mathematically model a given system
To apply already existing models and their associated equations to solve for various PK
parameters.
To prepare students for an academic or corporate position in the pharmaceutical sciences
such that they are able to converse with scientists from other disciplines about PK issues
in drug development, pre-clinical testing, and regulatory sciences.

Suggested Course Textbook:

Pharmacokinetics, M. Gibaldi and D. Perrier, Second Edition, Marcel Dekker, New York, NY, ISBN
0-8247-1042-8.
Fundamentals of International Regulatory Affairs, First Edition Spiral-bound 2010 by Regulatory
Affairs professionals Society, Publisher: Regulatory Affairs professional (2010), ISBN-10:
0978700651, ISBN-13: 978-0978700652
The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance May 1,
2000 by Malcolm K. Sparrow, Publisher: Brookings Institution press and the Council for
Excellence in Government (May 1, 2000), ISBN-10: 0815780656, ISBN-13: 978-0815780656.
Fundamentals of US regulatory Affairs, Eighth Edition paperback 2013 by RAPS (Author),
ISBN-10: 0982932065, ISBN-13: 978-0982932063
Notes and class handouts will be distributed by the instructors as needed
1

Course Format:
Classroom instruction. Lecture format.
Course Prerequisites:
Students enrolled in PHAR 5533 are strongly recommended to have completed a course in
ordinary differential equations (ODE), as well as received a grade of B or better in PHAR 7303.
However, as of January of 2013, the pre-requisites for the course have been suspended, and the
above courses are merely a suggestion, but not mandatory. This is so more co-discipline
students may enroll in this course.
Description of Assessment Methods:
There is one midterm examination and one final examination. Each examination is worth 50% of
the course grade. The final examination will not be cumulative over the entire semester, but
rather, will consist of material/topics covered by Dr. Shah. A letter grade is earned according to
the following grading scale; 90% = A; 80% = B; 70% = C; any percentage of the total
course points offered that is less than 70% constitutes a failing grade. Percentages will be
rounded upwards according to normal mathematical computations to ONLY the tenths place,
using the hundredths place to do so. An example would be a course grade of 89.47%. Using
this course grade, the 7 would be used to round the 4 in the tenths place to a 5, making the
course grade a 89.5%. By normal laws governing mathematical rounding, this would then
translate to a course grade of 90% and would correspond to an A. If the rounding had resulted
in a course grade of 89.4%, then the course grade would be 89% and the course letter grade
would correspond to a B. A course grade of 89.449% would not be rounded to 90% through a
series of successive rounding starting from the 3 rd number to the right of the decimal point, i.e.,
the 9. There are no exceptions to this course policy.
Date

Topics (Topics and Dates Subject to change)

Aug. 25
Aug. 27
Sept. 1
Sept. 3
Sept. 8
Sept. 10
Sept. 15
Sept. 17
Sept. 22
Sept. 24
Sept. 29
Oct. 1
Oct. 6
Oct. 8
Oct. 13
Oct. 15
Oct. 20
Oct. 22

Definitions of PK terms
IV bolus theory and practical data analysis
Laplace Transforms to solve ODEs in PKs
Cramers Rule and its application to Laplacian techniques; 1-compt PO analysis
Flip-flop PK, lag-time after p.o.; Vapp handout for 7303
Bioavailability (abs. and relative), bioequivalence, and trapezoidal rule
Derivation of the 2-compartment model eqs with i.v. input; vol. terms and ks
Derivation of the 2-compartment model eqs with i.v. input; vol. terms and ks
Derivation of the 2-compartment model eqs with i.v. input; vol. terms and ks
IV infusion slides I use for 7303
Multiple oral dosing slides I use for 7303
Two-compartment model with infusion at a constant rate
Two-compartment model with bolus plus infusion
Midterm Examination (Dr. Johnston)
Drug Development Process
Food and Drug Administration History and Organization
International Convention on Harmonization (ICH)
FDA Review and Approval Process for New and Generic Drugs with an emphasis on
PK and Biopharmaceutics
AAPS Annual Meeting
AAPS Annual Meeting
FDA Review and Approval Process for New and Generic Drugs with an emphasis on
PK and Biopharmaceutics

Oct. 27
Oct. 29
Nov. 3

Nov. 5
Nov. 10
Nov. 12
Nov. 17
Nov. 19
Nov. 24
Nov. 26
Dec. 1
Dec. 3
Dec. 8
Dec. 10

FDAs new drug/generic drug review and approval process

FDAs new drug/generic drug review and approval process
Regulatory perspective on pharmacokinetics and biopharmaceutics
Regulatory perspective on pharmacokinetics and biopharmaceutics
Prescription drug labelling = Summary of NDA/ANDA
Thanksgiving Holiday
Thanksgiving Holiday
Prescription drug labelling = Summary of NDA/ANDA
Discussion of selected regulations, guidelines, and warning letters
Discussion of selected regulations, guidelines, and warning letters
Final Exam (Dr. Shah)

Attendance Policy:
Attendance is absolutely mandatory for students in the School of Graduate Studies and who are
enrolled for coursework leading to the Ph.D. degree. Absence will only be accepted in the case
of death of a relative or serious illness of the student. Missing more than 3 lectures for Dr.
Johnstons material will disqualify you to sit for the midterm examination. Missing more than 3
class sessions for Dr. Shah will disqualify you to take the final examination. Individual
participation in Dr. Shahs lectures will be partially counted towards the final grade.
Standard Course Policies:
Please read the course policies via the following link.
http://phamacy.umkc.edu/current-students/#course_policies