1. INTRODUCTION CLINICAL PHARMACOKINETICS
Dr. Mohd B. Makmor Bakry, Ph.D., R.Ph.
Senior Lecturer in Clinical Pharmacy
Intensive Care Preceptor
Faculty of Pharmacy
Universiti Kebangsaan Malaysia

2. DEFINITION Pharmacology Pharmacodynamics Pharmacokinetics
Drug’s mechanism of action, indications, side effects, interactions and ADME
Pharmacodynamics
Drug-receptor activity, effects of drug to the body
Pharmacokinetics
ADME, kinetic orders, rates, concentration vs time profile.
Pharmacotherapeutics
Use of pharmacologic agents to manage patient specific problems/diagnosis.

3. WHAT IS CLINICAL PHARMACOKINETICS?
Concern about ADME, how to adjust the dosage regimen to suit the patient’s ADME characteristics and concentration vs time profile following the therapeutic planning.
The service known as Therapeutic Drug Monitoring (TDM) or Clinical Pharmacokinetic Services

4. WHAT TO THINK FOR? Why patient is individualized?
What affects drug absorption?
What affects drug distribution?
What affects drug metabolism?
What affects drug excretion?

5. SPECIFIC DRUG PHARMACOKINETICS
Indication(s)
Common and important side effects
Pharmacokinetics profile
Initiating and adjustment of therapy regimen
Monitoring therapeutic effects and side effects

6. After completion of the course, student should be able to:
Rationalized the indication of the drug.
Initiate drug regimen for the individual patient.
Take useful blood sample for analysis and interpretation.
Adjust the therapy regimen to suit the patient individual needs.
Monitor the disease progression and drug side effects.

7. BACKGROUND KNOWLEDGE Physiology Pharmacology Pathology
Normal organs function eg. the gut, the liver and kidney.
Pharmacology
Indication(s) of drug, drugs characteristics eg. absorption, distribution, metabolism and elimination, drug interactions.
Pathology
Pathophysiologic conditions eg. electrolytes imbalance, acid-base abnormalities, liver or kidney impairment.
Biopharmaceutics
Dosage form characteristics and route of administration.

8. THE PHASES 1 2 3 A D E M PHARMACOKINETICS Tablet (Q*) Q*-Receptor
BIOPHARMACEUTICS
PHARMACODYNAMICS A
mucosal D
blood
Tablet (Q*)
GIT
Q*-Receptor
tissue E
kidney/liver M
liver
Elimination
Metabolite

9. PHARMACOKINETIC PROCESSES
Absorption
Bioavailability (F)
The percentage of the administered dose that reaches the systemic circulation.
Absorption Rate (Ka)
The speed of input into the systemic circulation.
Distribution
Volume of Distribution (Vd)
The apparent volume into which the drug distributes within the body.
Protein Binding
The percentage of drug binds to the plasma protein.

10. PHARMACOKINETIC PROCESSES (CONT’)
Elimination
Clearance (CL)
The volume of drug cleared per unit time.
Elimination Rate Constant (Ke)
The proportion of drug in the body eliminated per unit time.
Elimination Half-life (t½)
The time taken for the concentration to fall to half the previous value.

11. CONCENTRATION VS TIME PROFILE (Oral Administration)Cp
A+D
D+E
Ke Ka A E
Ke t

12. CONCENTRATION VS TIME PROFILE (Parenteral Administration)Cp
D+E
Ke
Ke E t

13. CONCENTRATION VS TIME PROFILE (Continuous Infusion)Cp
Input = output
Input > Output t

14. CONCENTRATION VS TIME PROFILE (AUC, Cmax, tmax)Cp
Cmax
AUC t
tmax

15. CONCENTRATION VS TIME PROFILE (Formulation, onset, duration of action)Cp
Rapid absorbing
Slow absorbing
Sustained-release
Therapeutic
Range t

16. THANK YOU