This course presents the basic concepts and principles of biopharmaceutics and pharmacokinetics. The necessary mathematical expressions needed to characterize the absorption, distribution, metabolism, and excretion of drugs will be discussed with respect to routes of administration. Parameters that influence pharmacokinetic and therapeutic outcomes of the most common drug regimens will be emphasized. In addition, this course highlights some recent models i.e. compartmental models, their mathematical backbone and their relation to logical conclusions of drug time course in the body.
COURSE LEARNING OUTCOMES (CLO)
CLO: 1. To describe the mechanism, methodologies and mathematical approaches involved in drug elimination, protein binding and IV infusions.
CLO: 2. To illustrate pharmacokinetic variations in various disease states, biopharmaceutical considerations in product development and various approaches used in bioavailability and bioequivalence studies.
CLO: 3. To apply knowledge of biopharmaceutics and pharmacokinetics in in-vitro in-vivo correlation (IVIVC), product development and clinical settings
1 Determination of absolute bioavailability of the oral solution
2 Determination of absolute bioavailability of the oral tablet
3 Determination of absolute bioavailability of the oral capsule
4 Determination of relative bioavailability of the oral tablet with oral solution
5 Determination of relative bioavailability of the oral capsule with oral solution
6 Determination of bioequivalence of a generic formulation (anti-diabetic) with the reference formulation using urinary excretion data.
7 Determine the in vitro bioequivalence of an antihypertensive drug with the reference formulation
8 Det Determination of in-vivo bioequivalence of an antihypertensive drug with the reference formulation
9 Determination of creatinine clearance by different methods
10 Determination of pharmacokinetic parameters for multiple dose regimen after oral administration
11 Determination of pharmacokinetic parameters for multiple dose regimen after intravenous infusion
12 Dose adjustment regimen of renal compromised patients using ratio or proportion method and wagner method
13 Therapeutic drug monitoring and individualization of dosage regimen for a patient receiving aminoglycosides therapy
14 Determination of number of binding sites (n) and association constant (Ka) through double reciprocal plot method
15 Determination of number of binding sites (n) and the binding constant (Ka) through double
scatchard plot method
16 Understanding handling of animals (rabbit, rat, mice) and administration of a drug to them through oral, parental, subcutaneous and intraoperitonial route