Description
The course is concerned with the exploration and examination of the physicochemical properties of drugs in the physiological environment and their impact on product performance in vitro and in vivo. It explores the principles of biopharmaceutics and strategies for enhancing drug delivery and bioavailability in addition to specialized knowledge essential to understand the concept of bioequivalence. Also, it introduces the students to basic pharmacokinetic parameters and mathematical aspects. General principles of pharmacokinetic models are presented as they pertain to the process of absorption, distribution and elimination of drugs in humans and the significance of these processes in drug therapy. Topics also emphasize linear and nonlinear metabolic clearance kinetics, drug-drug interaction mechanisms and kinetics, in vitro-in vivo predictions, pharmacogenetics and other sources of inter-individual variability. The course also covers the theoretical considerations of reaction kinetics in terms of reaction orders, influence of temperature, catalysis and others in order to estimate drug product shelf life and determine its storage conditions.
Program
PharmD Clinical
Objectives
- a. Knowledge and Understanding
By the end of the course the student should be able to:
a1. Define different pharmacokinetic parameters including: clearance, apparent volume of distribution, elimination rate constant, and elimination half-life.
a2. Recognize the various pharmacokinetic parameters that can be obtained following single and multiple intravenous and oral drug administration doses.
a3. Define and differentiate between pharmacokinetics of non-potent drugs and narrow therapeutic index drugs.
a4. Define different steps involved in drug dissolution in gut lumen, absorption, distribution and elimination.
b. Intellectual Skills
By the end of the course the student should be able to:
b1. Calculate the elimination half-life, elimination rate constant, absorption rate constant, apparent volume of distribution, and total body clearance from the plasma concentrations-time curve following administration of drug using different routes of administration.
b2. Determine the diffusion rate, dissolution rate and effect of acidity or alkalinity on drug ionization and solubility.
b3. Estimate the oral bioavailability of drugs from plasma concentration-time profile of drugs.
b4. Applying problem solving skills and critical thinking to reach proper pharmaceutical decisions as dose initiation, maintenance and modification.
b5. Analyze different factors affecting drug absorption, distribution, metabolism and excretion from GIT.
c. Professional and Practical skills
By the end of this course the student should be able to:
c1. Interpret plasma concentration- time profiles following administration of drugs via different administration routes.
c2. Gain the mathematical skills for necessary calculations of different pharmacokinetic parameters.
c3. Interpret effect of formulation additives on in-vitro drug release profile and in-vivo performance of the drug product.
d. General and Transferable skills
By the end of this course the student should be able to:
d1. Gain problem solving skills related to pharmacokinetic parameters estimation.
d2. Extend information gained to understand pharmacokinetic aspects of different drug administration routes.
d3. Work individually to present the required tasks with effective time management skills.
d4. Develop effective communication skills.
