PHM3172 - International Islamic University Malaysia

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Dec 3, 2012 (4 years and 11 months ago)

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Last updated
6
/08/
2009

by Taher

1


INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA

COURSE OUTLINE



Kulliyyah

Pharmacy

Department

Pharmaceutical Technology

Programme

B. Pharm.

Course Title

Biopharmaceuticals


Course Code

PHM

31
7
2

Status

Elective

Level

3000 (Year 3)

Credit Hours


2

Co
ntact Hours

L =
2
2
h
, T = 4h.

Industrial v
isit
= 6h
Total =
28 CH

Pre
-
requisites

(if any)

PHM2
17
2 Pharmaceutical Technology

Co
-
requisites

(if any)

Nil

Instructional

Strategies

Lecture

Assignment
s/reports

Tutorial

Visits


Course
Assessment









LO

Methods

%


Assignment
s/reports

10


Mid
-
Semester Exam

40

1,2,3


MCQs 10 Questions

10



Duration: 20 min


1,2,3


Short Essays
3
out of
4
questions

15

1,2,3


Long Essays
2

out of
3

questions

15



Duration: 1 hr

30 mins


Last updated
6
/08/
2009

by Taher

2














End
-
Semester Exam

50

1
-
6


Short Essays 4 out of 6 questions

20

1
-
6


Long Essays
3

out of 4 questions

30



Duration: 2 hrs

30 mins









Instructor(s)

Dr. Muhammad Taher

Dr. Wan Azizi

Wan Sulaiman

Dr. Solachuddin A.J. Ichwan


Sem
ester
Offered

1

Course Synopsis

This course provid
es

a
n advanced
understanding
in
biotechnology
-
based
pharmaceuticals

or biopharmaceuticals.

This course is a continuation of
Pharmaceutical Biotechnology that giving basic understanding on
b
iopharmaceutical
s.


Course
Objectives

This course is designed to provide understanding on the biopharmaceutical
technologies and processes in drug development and the biotechnology
perspective on drug development. The course will also provide understanding
on the recent

progress
in the field of bio
pharmaceuticals
, the utilization of
this
various

biopharmaceutical

products in clinical application.



Learning
Outcomes

At the end of the course, students will be able to:

1.

Describe t
he concepts of
biopharmaceutical
drug
devel
opment and
approval.

2.

Explain the biotechnology perspective on pharmaceutical
progress suc
h

as stem cell, molecular farming and gene therapy.

3.

Explain the aspects of biotechnology in
drug delivery
,
pharmacokinetic

and pharmacody
n
a
m
ic.

4.

Discuss the
role of ge
nomics and proteomics
.

5.

Discuss the different types of biopharmaceutical products such as
interferon
, interle
u
kin
s
,
hematopoietic

growth factors, blood products

and hormones.

6.

D
iscuss

the
bioethical
perspectives

in
biopharmaceuticals

field
.










Last updated
6
/08/
2009

by Taher

3

Content

Outlines

Weeks


Topics

Task / Reading

1



1


2

Introduction to biopharmaceuticals


Drug development process

Walsh (2003)

Chapter 2

2.

1



2

Immunogenicity of therapeutic
proteins


Production and downstream
processing of biopharmaceuticals I




Gad

(20
0
7
)


Cromelin & Sindelar (2002)

Chapter 3

3.

1



2

Production and downstream
processing of biopharmaceuticals
I
I


Pharmacokinetics and
pharmacodynamic of
biopharmaceutical products

I


Cromelin & Sindelar (2002)

Chapter 3


Kayser & Muller (2004)

Chapter 8

Cromelin & Sindelar (2002)

Chapter 5

4

1




2

Pharmacokinetics and
pharmacodynamic of
biopharmaceutical products

II

Tutorial 1

Kayser
&
Muller (2004)

Chapter 8

Cromelin & Sindelar (2002)

Chapter 5

5


Industrial Visit


6


1


2





Stem cell research

I


Stem cell research II


Sell (2004)

7

1





2

Molecular farming

Production of therapeutic protein in
transgenic plant.



Tutorial
2


Kayser
&
Muller (2004)

Chapter 3


Last updated
6
/08/
2009

by Taher

4

8

1






2


Gene and Cell Therapy

Overview of gene and cell therapeutics.

Delivery and e
xpression of genes
encode functional proteins.




Antisense
t
herapy


Ho & Gibaldi (2003)

Chapter 15

Walsh (2003)

Chapter 11

Groves(2006)

Chapter 13


Glick & Pasternak (2003)

Chapter 10


9

1



2

Interferon family

Cytokines and interferon


Interleukins and
tumor necrosis
factor

Walsh
(
2004
)

Chapter

4


Walsh
(
2004
)

Chapter 5

10

1






2

Haematopoietic growth factor

Erythropoietin, granulocyte and
macrophage colony stimulating factor

(G and M
-
CSF)


Blood products and
therapeutic

enzymes

Haemostasis

and c
lotti
ng factors

Walsh
(
2004
)

Chapter 6

Cromelin & Sindelar (2002)

Chapter 8



Walsh
(
2004
)

Chapter 9


1
1

1





2

Hormones

Insulin, glucagons and human growth
hormone
: production, formulation and
engineering


Tutorial 3

Walsh
(
2004
)

Chapter

8

12

1




2



Advan
ced
drug delivery

I:

Rationale
and basic principles. Physiology and
mechanistic approaches.
taher


Advanced drug delivery

II
:
Approaches using devices.

Molecular
approaches



Ho & Gibaldi (2003)

Chapter 13


Last updated
6
/08/
2009

by Taher

5

1
3

1











2

Integration of
pharmacokinetic
and
pharmacogenetic principles
in
drug
t
herapy

Perspective on pharmacogenetics

Pharmacogenetics: Drug metabolism
and transport. Pharmacogenetiecs:
Therapeutic response. Individualized
gene
-
based medicine. Current and
potential application of
pharmacogeneti
cs


Tutorial 4


Ho & Gibaldi (2003)

Chapter 14


14

1








2

The Role of Genomics and
Proteomics

Genomics: the first link between
sequences and drug targets. Proteomic:
From sequences to functions.

Integrating proteomic and genomic
tools to accelerate dr
ug development.


Biotechnology and Bioethics

Ho & Gibaldi (2003)

Chapter 16







Bryant, Baggot la Velle & Searle
(2005)

Chapter 5

References

Required



Ho, R.J.Y., & Gibaldi, M. (2003).
Biotechnology and Biopharmaceuticals
.


New Jersey: Jo
hn Wiley and Sons.



Walsh, G. (
200
7
).
Biopharmaceuticals: Biochemistry and Biotechnology

(
3
nd

ed.).
Chichester: John Wiley and Sons.





Recommended


Bryant, J., Baggot la Velle, L., & Searle, J. (2005).
Introduction to Bioethics
.
Chichester

: John Wiley

and Sons.


Glick, B. R., & Pasternak, J. J. (2003
).
Molecular Biotechnology: Principles and

Application of Recombinant DNA

(2
nd

ed.). Washington D.C.: ASM Press.

Last updated
6
/08/
2009

by Taher

6

Gad, S.C. (ed) (2007).
Handbook of Pharmaceutical Technology
. New Jersey:
Wiley Interscience
.

Groves, M.J. (2006).
Pharmaceutical Biotechnology

(2
nd

ed.).

Boca Raton: Taylor and Francis.


Muller, R.H., & Kayser, O. (2004).
Pharmaceutical Biotechnology
.


Weinheim: Wiley
-
VCH.



Sell, S. (2004).
Stem Cells
. New Jersey: Humana Press.


Sindelar, R.D., & Crommelin, D.J.A. (2002).
Pharmaceutical Biotechnology
.
Taylor & Francis.


Thieman, W.J., & Palladino, M.A. (2004).
Introduction to Biotechnology
.

San Francisco: Benjamin Cummings.




Proposed
Start Date
(Semester)

Year 200
9
/20
10

Seme
ster
1

Batch of
Students to
be Affected

Year 200
7
/200
8
. (All Batches)






Prepared by:



Checked by:




Approved by:


__________________


__________________


_____
______________

(Dr. Muhammad Taher)



(


)

(Prof.
Dr.
Tariq Abdul Razak
)




Last updated
6
/08/
2009

by Taher

7

Course Assessment Matrix: PHM 3192






Course Learning Outcomes


Programme Outcomes


Outcome 1

Outcome 2

Outcome 3

Outcome 4

Outcome 5

Outcome 6

Outcome 7

Outcome 8

Outcome 9

Outcome 10

Describe t
he concepts of drug development and approval.

1

1





2

2



Explain the biotechnology perspective on pharmaceutical progress such as stem
cell, molecular farming and gene therapy.


3





2




Explain the aspects of biotechnology in

drug delivery, pharmacokinetic and
pharmacodynamic.


2



1


3

1



Discuss the role of genomics and proteomics
.


3

1


2


1

2



Discuss the different types of biopharmaceutical products such as interferon,
interleukins, hematopoietic growth factors, blood

products and hormones.


3





1

1



Discuss the bioethical
perspectives in biopharmaceuticals field.


2



1


3

















































*1=objective addresses outcome slightly, 2=moderately, 3=substantive

Last updated
6
/08/
2009

by Taher

8

The educational outc
omes of the programme conducted by the Kulliyyah of Pharmacy


At the end of the programme, students should have the ability to:


1.

describe professional ethics for pharmacists and discuss scientific issues from the Islamic perspective.

2.

integrate knowledge i
n all aspects of drugs beginning with their origin (synthetic or natural products), medicinal chemistry,
pharmacology, compounding or manufacturing and their usage.

3.

perform the roles of pharmacists in hospital and community settings equipped with knowledge

related to pharmacy
administration and management, ability to analyze and solve problems related to pharmacy administration and management.

4.

analyse the common signs and symptoms, laboratory findings and drugs in the management of common disorders and
mali
gnancies involving all body systems.

5.

integrate the concepts of pharmaceutical care, pharmacotherapeutics and clinical pharmacokinetics in the identification and
resolution of drug related problem.

6.

apply effective communication skills in the delivery of pha
rmaceutical care, perform patient counselling and monitoring.

7.

perform the roles of pharmacists in compounding or manufacturing of various dosage forms on both, a small scale and a large
scale, that comply with the principles of GMP, quality control and qua
lity assurance.

8.

apply the principles and rationale of drug delivery systems, develop and design drug delivery systems.

9.

develop practical skills of research in pharmaceutical sciences.

10.

to relate anatomical structure to physiological function and the effects

of drugs on these functions.