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Course Code: 
PHAR 412
Course Period: 
Spring
Course Type: 
Core
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
English
Course Objectives: 
The aim of this course is to provide students with a sound knowledge of basic pharmacokinetic concepts, and their application to drug development and optimization of dosage regimen.
Course Content: 

a) Theory: Kinetics drug absorption, distribution and elimination, compartmental models describing the kinetics of drugs, pharmacological response kinetics, nonlinear pharmacokinetics, application of pharmacokinetic principles.

b)Laboratory applications/Practical: ---

Course Methodology: 
1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5:Simulation, 6: Video, 7: Applications, 8:Case Study
Course Evaluation Methods: 
A:Written exam, B: multiple chose , C:Filing the blank D:False and troth, E: Oral Exam F: Portfolio, G: Contrabution of course activities H:Homework

Vertical Tabs

Course Learning Outcomes

Learning Outcomes

Programme Learning Outcomes*

Teaching Methods**

Assessment Methods***

1) Students’ ability to explain the basic concepts of pharmacokinetics

1, 2

1, 2, 3, 4

A, B, H

2) Students’ ability to explains pharmacokinetic parameters of drugs

1, 2

1, 2, 3, 4

A, B, H

3) Students’ ability to apply pharmacokinetic concepts to optimization of dosage regimen in specific clinical situations.

1, 2, 7, 8, 14

1, 2, 3, 4

A, B, H

4) Students’ ability to apply pharmacokinetic concepts to drug discovery and preclinical development.

1, 2, 7, 8, 14

1, 2, 3, 4

A, B, H

5) Students’ ability to apply pharmacokinetic concepts to the development of drug product.

1, 2, 7, 8, 14

1, 2, 3, 4

A, B, H

 
 

Course Flow

Week

Theorical Topics                                     

Lab content

Study Materials

1

Basic Concepts for Pharmacokinetics (PKs): Definition of ADME processes, drug transport across biological membranes, time course of drug & metabolites in and outside the body, measurement  and significance of drug concentration in various biological fluids.

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---

2

Basic Concepts for Pharmacokinetics: Concept of compartment in PKs, definition of linear and nonlinear PKs and pharmacokinetic models, mathematical fundamentals for PKs, orders of rate processes (Zero-order, 1st order).

---

---

3

Drug Absorption: Difference between absorption and bioavailability, absorption from  various routes of drug administration and typical plasma profile, factors that affecting absorption, first- and zero-order rates of drug absorption, calculation of absolute and relative bioavailability.

---

---

4

Drug Distribution and Protein Binding: Physiologic factors of drug distribution, drug reservoirs (accumulation), rate of drug distribution, extent of distribution (volume of distribution).

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---

5

Drug Distribution and Protein Binding: Characteristics of drug-plasma protein binding, methods of determining protein binding, kinetics of protein binding (calculation of binding constant and number of binding sites on protein molecule), effect of protein binding on distribution and elimination, clinical significance of drug protein binding.

---

---

6

Drug Elimination: Functions of drug metabolism, sites of metabolism, types of metabolic reactions, factors affecting drug metabolism, mechanism of metabolism induced toxicity, drug excretion by various routes.

---

---

7

Drug Elimination: Determination of relative amount of metabolism and excretion, expressions for elimination rate (clearance), calculation of elimination, excretion and metabolic rate constants, organ clearance model, creatinine clearance, hepatic extraction ratio and classification of drugs on the basis of it, characteristics of high hepatic extraction ratio drugs, determination of renal and hepatic clearance.

---

---

8

Pharmacokinetic Models: Determination of whether body behaves as one- or multi-compartment, IV bolus-one compartment pharmacokinetic model, determination of duration of drug action and volume of distribution, IV bolus-2 and 3- compartment models.

---

---

9

Pharmacokinetic Models: Main reasons for applying drug as IV infusion, steady-state plasma concentration, IV infusion- one compartment model.

---

---

10

Pharmacokinetic Models: One compartment model for oral administration with 1st and zero-order absorption, calculation of time required to reach peak plasma concentration.

---

---

11

Pharmacokinetic Models: One compartment model for multiple IV bolus dosage administration, one compartment model for multiple IV infusion, one compartment model for multiple oral dosage administration.

---

---

12

Nonlinear Pharmacokinetics: Saturable enzymatic elimination processes, equations for drugs eliminated by nonlinear pharmacokinetics, chronopharmacokinetics and time-dependent pharmacokinetics.

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---

13

Relationship between Pharmacokinetics and Pharmacodynamics:

Relation of dose, rate of absorption, distribution and elimination to pharmacologic response, pharmacokinetic drug tolerance, pharmacodynamic models (maximum effect model, sigmoid model) and hysteresis of pharmacodynamic response.

---

---

14

Application of Pharmacokinetic Principles in Clinical Situations: Determination of dose, dosage interval and route of administration, individualization of dosage regimen and therapeutic drug monitoring.

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---

15

Application of Pharmacokinetic Principles in Clinical Situations: Dosing for infant, children, elderly and obese patients, pharmacokinetic drug interaction, dosage adjustment in renal and hepatic diseases.

---

---

 
 

Recommended Sources

Textbook

1. Leon Shargel, Susanna Wu-Pong, Andrew B.C. Yu. Applied Biopharmaceutics and Pharmacokinetics, Sixth Edition, McGraw-Hill Education, 2012.

2. Joseph T. DiPrio, William J. Spruill, William E. Wade, Robert A. Blouin, Jane M. Pruemer. Concepts in Clinical Pharmacokinetics, Fifth Edition, American Society of Health-System Pharmacists Inc., 2010.

3. Malcolm Rowland, Thomas N. Tozer. Clinical Pharmacokinetics: Concepts and Applications, Third Edition, Lippincott Williams & Wilkins, Philadelphia, 1995.

Additional Resources

 

 
 

Material Sharing

Documents

Power point presentarions

Assignments

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Exams

---

 
 

Assessment

IN-TERM STUDIES

NUMBER

PERCENTAGE

Midterm  Exam

1

80

Quizzes

5

10

Lab./assignment

1

10

Total

 

100

CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE

 

60

CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE

 

40

Total

 

100

 

 

COURSE CATEGORY

Compulsary

 
 

Course’s Contribution to Program

No

Program Learning Outcomes

Contribution*

1

2

3

4

5

1

Acquire skills needed to practice the profession of pharmacy in either a Turkish or an English language setting.

   

X

   

2

Being equipped to access current theoretical and applied knowledge, keeping abreast of new developments, and possessing the critical faculties enabling an accurate and reliable interpretation and assessment of this information.

   

X

   

3

Having the capacity to apply the skills acquired in the field of pharmaceutical science. Possessing the ability to harness his/her acquired knowledge in order to function as a highly accessible health counsellor, providing a ready source of clinically relevant, health-related information to the general public.

X

       

4

Keeping abreast of and being equipped to apply the fundamental pharmaceutical and health science principles which guide future developments in modern technology, and being able to share these experiences and skills with colleagues through participatation in professional development education seminars.

X

       

5

Knowing how to assess risks arising from the use of drugs and other chemicals and those risks potentially encounterd during laboratory practice.

X

       

6

Acquiring the skills and knowledge needed to interpret findings obtained through quantative and qualitative measurements, and thus reach valid, scientific conclusions based on this data. 

X

       

7

Being able to compound pharmaceutical products while being knowledgable about their clinical application, interactions, side effects and risks  and apply in proper manner.

       

X

8

Being competent to conduct and manage research and development projects, and share experimental outcomes.

       

X

9

Be competent to accurately and intelligibly communicate clincally relevant information to patients concerning prescription items and other pharmaceutical products.  

X

       

10

Being able to function in a multidisciplinary environment. Possessing the skill to collaborate and establish lines of communication with other professionals, while developing their own professional competency through participation in relevant continuing education activities.

X

       

11

Being able to play a role in projects which fulfills the profession’s societal responsibilities. Participating in professional activities and undertaking duties in a manner which reflects an awareness of and sensitivity to environmental issues.

X

       

12

Being capable of opening a community pharmacy, practicing in a hospital pharmacy setting, and offering service in any field related to drugs, cosmetics, medical  and/or plant-derived products. Able to play an active role in his/her own personal professional development, as well as that of colleagues and pharmaceutical students.

X

       

13

Able to play a role in issues related to public health as a member of the health care team while being cognizant of and able to fulfill legal and professional requirements and maintain ethical standards. 

X

       

14

Is knowledgable of and equipped to manage the planning, development, compounding and quality control analysis of naturally occuring and synthetic medicines, while also being aware of the processes related to these products’ absorption, distribution, metabolism and excretion from the body.

       

X

 
 

ECTS

Activities

Quantity

Duration
(Hour)

Total
Workload
(Hour)

Course Duration (Including the exam week)

16

2

32

Hours for off-the-classroom study (Pre-study, practice)

16

2

32

Midterm Examination

1

1

1

Lab. Applications

---

   

Hours for off-the-Lab. study (Pre-study, practice)

---

   

Lab. Midterm Examination

---

   

Lab. Final

---

   

Homework/Assignment

2

5

10

Final  Examination

1

2

2

Total Work Load

 

 

77

Total Work Load / 25 (h)

 

 

3.08

ECTS Credit of the Course

 

 

3