Annexure ‘CD – 01’

FORMAT FOR COURSE CURRICULUM

L T P/S SW/FW No. of TOTAL

PSDA CREDIT
Course Title: Fundamentals & Applications of Pharmaceutical Biotechnology Credit Units: 04 UNITS
3 - - 2 04 04
Course Level:PG
Course Code: BIOT 337 Course Objectives: The objective of this course is to understand and apply the basic concepts of Pharmaceutical
Biotechnology for Commercial Units. The students will understand various classes of biotech products, regulations governing production and marketing of
biotech & pharmaceutical products. The student will gain insight into the working of biotechnology & pharmaceutical industries.

Pre-requisites: Human physiology, Cell biology and Molecular Biology, C hemistry

Course Contents/Syllabus:
Weightage (%)

Module I Introduction to Pharmaceutical Biotechnology 25

Process of drug discovery and development: methods and timelines involved; Introduction to biopharmaceuticals-
comparison with small molecule drugs; generics; biosimilars; overview of biopharmaceutical industry
Module II Pharmacodynamics & Pharmacokinetics 25
Principles of pharmacodynamics, Drug receptor interaction, Potency and therapeutic index , Pharmacodynamic
models and biomarkers , General principles of pharmacokinetics , Route and timing of administration, Plasma
concentration and its relationship to drug actions, Principles of bioavailability/bioequivalence , Adverse drug
reactions

Module III Biological and novel therapies 25

Vaccines: Definition and Development of Vaccine, Classification of vaccines, DNA Vaccine, Monoclonal
Antibodies based pharmaceuticals, Interferons, interleukins and growth factors as biologics, gene therapy and
immunotherapeutic drugs, Bioreductive drugs, Cancer vaccines.

Module IV Quality Standards 25

Good Manufacturing Practice (GMP’s), Good Lab Practices, Regulatory Issues and Drug Product Approval for
Biopharmaceuticals

Student Learning Outcomes:

After completing this course, the student will be able to:

 Describe the mechanism of drugs development and drug discovery

 Acquired knowledge rega rding basic pharmacology

 Comprehensive knowledge regarding the development and use of Bioceutics

 Identify and appraise the guide lines and ethical concerns regarding the use of drugs

Pedagogy for Course Delivery:

(a) Lecture Plan/Session Plan :
Lectures: 39
PSDA activities: 15
Assessments: 06

List of Professional Skill Development Activities (PSDA):

i. Interaction with expert from Industry/Research

ii. Group Discussion
iii. Group Presentation
iv. Career talk by domain expert

Assessment/ Examination Scheme:

Theory L/T (%) Lab/Practical/Studio (%)

100 0

Theory Assessment (L&T):

Continuous Assessment/Internal Assessment End Term Examination
(30 %) (70%)
Components (Drop down) Class test PSDA activity Presentation Attendance
 participation

Linkage of PSDA with - Yes Yes -

Internal Assessment
Component, if any
Weightage (%) 10 10 5 5 70

Lab/ Practical/ Studio Assessment: NA

Text & References

Biopharmaceuticals and industrial prospective. Gray Walsh & B. Murphy, Kluwer publishers
(1999).
Biopharmaceuticals. Gray Walsh, Wiley John & Sons, Inc. (2003).
The practice of Medicinal chemistry. Camille G. Wermuth, Academic P ress, (2003).