Biopharmaceuticals and Biosimilars detailed syllabus for Biotechnology (BioTech) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BioTech students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Biotechnology 5th Sem scheme and its subjects, do visit BioTech 5th Sem 2021 regulation scheme. For Professional Elective-III scheme and its subjects refer to BioTech Professional Elective-III syllabus scheme. The detailed syllabus of biopharmaceuticals and biosimilars is as follows.
Course Objectives:
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Unit I
INTRODUCTION 9
Drug sources – Discovery and Development phases – Drugs and Cosmetics Act and regulatory aspects – Role of patents in the drug industry – Biopharmaceutical classification system – Drug Target – Drug metabolism – Pharmacokinetics – Pharmacodynamics – Bioavailability -Bioequivalence – Toxicity studies – Pharmacogenomics.
Unit II
DOSAGE FORMS 9
Classification of dosage forms – Excipients – Formulation – Tablets, Capsules, Emulsion, Suspension, Lotion, Liniments, Ointments, Cream, Paste, Suppositories, Parenterals – Pressurized dosage forms – Packaging techniques.
Unit III
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Unit IV
BIOSIMILARS 9
Biosimilar medicine – Importance – INN nomenclature system – Key trends in biosimilar product development – Production of biosimilar products – Difficulties with biosimilar drugs – Non clinical and clinical study – Regulation and approval process – Future prospects.
Unit V
CASE STUDIES ON BIOPHARMACEUTICALS 9
Erythropoietin – Insulin – Somatotropin – Interleukin – Interferon – GMCSF – Blood clotting
Factors – Tissue plasminogen activator – Monoclonal antibodies and engineered antibodies.
Course Outcomes:
Upon completion of the course, students will be able to
- Comprehend the factors influencing the bioavailability and bioequivalence of drugs.
- Grasp the current regulatory acts and safety norms of the modern pharmaceutical industries.
- Recognize the formulation concepts and evaluate different dosage forms to meet out the compendial requirements.
- Acquired knowledge on novel drug delivery systems and their applications in therapeutic fields.
- Understand the design and analysis of biosimilar drugs.
- Demonstrate knowledge and understanding of current topical and newly emerging aspects of biopharmaceuticals.
Text Books:
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Reference Books:
- James Swarbrick, “Encyclopedia of Pharmaceutical Technology”, CRC Press, 4th Edition, 2013.
- Shayne Cox Gad, “Pharmaceutical Manufacturing Handbook: Production and Processes”, Wiley, 2nd Edition, 2011.
For detailed syllabus of all the other subjects of Biotechnology 5th Sem, visit BioTech 5th Sem subject syllabuses for 2021 regulation.
For all Biotechnology results, visit Anna University BioTech all semester results direct link.