COLLEGE OF PHARMACY

3/F St. Therese Bldg.

900 San Marcelino St.
1000 Ermita, Manila
Tel. No.: (02) 521-2621
(02) 524-2011 local 390

Table of Specifications Biopharmaceutics and Pharmacokinetics

SY 2016-2017

Cognitive Domains
Weight in
Topic Objectives Remembering Understanding Applying Analyzing Evaluating Creating
Percentage
(Knowledge) (Comprehension) (Application) (Analysis) (Synthesis) (Evaluation)
I. Introduction to Define and differentiate between 17, 18, 19, 20, 5, 6, 16, 9%
Pharmacokinetics & pharmacokinetics and clinical 21, 22,
Pharmacodynamics pharmacokinetics.

Define pharmacodynamics and relate it to

pharmacokinetics.

Describe the concept of the therapeutic

concentration range.

Identify factors that cause interpatient

variability in drug disposition and drug
response.
II. Basic Calculate the volume of distribution. 14, 9, 10, 7, 8, 5%
Pharmacokinetics
Identify the components of body fluids
that make up extracellular and
intracellular fluids and know the
percentage of each compartment.

Define drug clearance and show how it is

related to organ blood flow.

Describe the difference between first- and

zero-order elimination and how each
appears graphically
III. Half-life, Calculate the elimination rate constant II.1.a, II.1.b, 35%
 COLLEGE OF PHARMACY
3/F St. Therese Bldg.
900 San Marcelino St.
1000 Ermita, Manila
Tel. No.: (02) 521-2621
(02) 524-2011 local 390
Elimination rate, & Area given a natural log of plasma drug II.1.c, II.2., II.3,
Under the Curve concentration versus time curve. II.4.d

Define half-life and calculate drugs half-

life.

Describe the relationship between half-life

and elimination rate constant.

Define drug clearance and relate it to the

area under the plasma drug concentration
curve and drug dose.

Calculate a drugs volume of distribution,

concentration at time zero, and area
under the plasma concentration versus
time curve.

IV. One and Two Discuss the different factors affecting 1, 2, 3, 4, 13, 11, 12, 23, 24, 13%
Compartment Model drugs absorption, distribution, 15, 28, 29 25,
metabolism, and excretion.
V. Drug Absorption,
Distribution, and Describe the principle of superposition
Elimination and how it applies to multiple drug dosing.

VI. Multiple Define steady state and describe how it

Dosage Regimen relates to a drugs half-life.
A. Repetitive
Intravenous Injection Calculate the estimated peak and trough
B. Determination of plasma concentration after multiple drug
Bioavailability and dosing.
Bioequivalence in a
Multiple Dose Regimen
VII. Nonlinear Describe the relationship of both drug II.4.a, II.4.b, 15%
Pharmacokinetics concentration and area under the plasma II.4.c,
A. Non Linear drug concentration versus time curve to
Pharmacokinetics to the dose for a nonlinear, zero-order
Protein Binding process.
 COLLEGE OF PHARMACY
3/F St. Therese Bldg.
900 San Marcelino St.
1000 Ermita, Manila
Tel. No.: (02) 521-2621
(02) 524-2011 local 390
B. Application of
Pharmacokinetics to Explain the various biopharmaceutic
Clinical Situations process that can result in nonlinear
(Determination of pharmacokinetics.
Dose, Route of
Administration) Use Michaelis-Menten model for
describing nonlinear pharmacokinetics
VIII. Bioavailability and to predict plasma drug concentration.
and Bioequivalence
Differentiate and discuss the importance
of conducting bioavailability and
bioequivalence studies.

Discuss the different factors affecting the

drugs bioavailability.

Apply mathematical operations to

compute for the drugs bioavailability.
IX. Pharmacokinetic Discuss the pharmacokinetic 26, 27, 30, 31, 23%
Of Special Populations considerations to special groups of 32, 33, 34, 35,
X. Drug population. 36, 37, 38, 39,
Developmen 40, 41, 42, 43,
t Describe the stages of pharmaceutical 44, 45, 46, 47,
product development. 48, 49, 50

Name the pharmacokinetic studies

undertaken during each stage of
pharmaceutical product development.

Prepared by:

APRIL MERGELLE R. LAPUZ, RPH

Approved by:

PERLITA M. CRUCIS, RPH, MSPHARM

 COLLEGE OF PHARMACY
3/F St. Therese Bldg.
900 San Marcelino St.
1000 Ermita, Manila
Tel. No.: (02) 521-2621
(02) 524-2011 local 390
Table of Specification Biopharmaceutics and Pharmacokinetics

Weight in
Type of Exam
Percentage
Topic Objectives
Multiple Fill in the Matching Problem
Identification Essay
Choice blank Type Solving
II. Introduction to Define and differentiate between 5, 6, 16, 17, 18, 9%
Pharmacokinetics & pharmacokinetics and clinical 19, 20, 21, 22,
Pharmacodynamics pharmacokinetics.

Define pharmacodynamics and relate it to

pharmacokinetics.

Describe the concept of the therapeutic

concentration range.

Identify factors that cause interpatient

variability in drug disposition and drug
response.
II. Basic Calculate the volume of distribution. 7, 8, 9, 10, 14, 5%
Pharmacokinetics
Identify the components of body fluids
that make up extracellular and
intracellular fluids and know the
percentage of each compartment.

Define drug clearance and show how it is

related to organ blood flow.

Describe the difference between first-

and zero-order elimination and how each
appears graphically
VII. Half-life, Calculate the elimination rate constant II.1.a, II.1.b, 35%
Elimination rate, & given a natural log of plasma drug II.1.c, II.2., II.3,
Area Under the Curve concentration versus time curve. II.4.d

Define half-life and calculate drugs half-

 COLLEGE OF PHARMACY
3/F St. Therese Bldg.
900 San Marcelino St.
1000 Ermita, Manila
Tel. No.: (02) 521-2621
(02) 524-2011 local 390
life.

Describe the relationship between half-

life and elimination rate constant.

Define drug clearance and relate it to the

area under the plasma drug
concentration curve and drug dose.

Calculate a drugs volume of distribution,

concentration at time zero, and area
under the plasma concentration versus
time curve.

VIII. One and Two Discuss the different factors affecting 1, 2, 3, 4, 11, 13%
Compartment Model drugs absorption, distribution, 12, 13, 15, 23,
metabolism, and excretion. 24, 25, 28, 29
IX. Drug Absorption,
Distribution, and Describe the principle of superposition
Elimination and how it applies to multiple drug
dosing.
X. Multiple
Dosage Regimen Define steady state and describe how it
C. Repetitive relates to a drugs half-life.
Intravenous Injection
D. Determination of Calculate the estimated peak and trough
Bioavailability and plasma concentration after multiple drug
Bioequivalence in a dosing.
Multiple Dose Regimen
VIII. Nonlinear Describe the relationship of both drug II.4.a, II.4.b, 15%
Pharmacokinetics concentration and area under the plasma II.4.c,
C. Non Linear drug concentration versus time curve to
Pharmacokinetics the dose for a nonlinear, zero-order
to Protein Binding process.
D. Application of
Pharmacokinetics Explain the various biopharmaceutic
to Clinical process that can result in nonlinear
Situations pharmacokinetics.
 COLLEGE OF PHARMACY
3/F St. Therese Bldg.
900 San Marcelino St.
1000 Ermita, Manila
Tel. No.: (02) 521-2621
(02) 524-2011 local 390
(Determination of
Dose, Route of Use Michaelis-Menten model for
Administration) describing nonlinear pharmacokinetics
and to predict plasma drug concentration.
IX. Bioavailability
and Bioequivalence Differentiate and discuss the importance
of conducting bioavailability and
bioequivalence studies.

Discuss the different factors affecting the

drugs bioavailability.

Apply mathematical operations to

compute for the drugs bioavailability.
XI. Pharmacokineti Discuss the pharmacokinetic 26, 27 30, 31, 32, 33, 23%
c considerations to special groups of 34, 35, 36, 37,
Of Special Populations population. 38, 39, 40, 41,
XII. Drug 42, 43, 44, 45,
Developme Describe the stages of pharmaceutical 46, 47, 48, 49,
nt product development. 50

Name the pharmacokinetic studies

undertaken during each stage of
pharmaceutical product development.

Prepared by:

APRIL MERGELLE R. LAPUZ, RPH

Approved by:

PERLITA M. CRUCIS, RPH, MSPHARM