BY4013 Biopharmaceuticals and Biosimilars Syllabus:
BY4013 Biopharmaceuticals and Biosimilars Syllabus – Anna University PG Syllabus Regulation 2021
COURSE OBJECTIVES:
1 To provide knowledge in core responsibilities for the development and monitoring of the drug and the preparation of medicines according to the norms.
2 To gain knowledge in physicochemical properties, pharmacology and the formulation of commonly used biopharmaceuticals.
3 To educate about the recent advancements in drug delivery systems.
4 To educate about the biosimilars medicine and its future prospects
5 To provide the applications of biopharmaceuticals in respect to clinical aspects.
UNIT I INTRODUCTION
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
Classification of dosage forms – Excipients – Formulation – Tablets, Capsules, Emulsion, Suspension, Lotion, Liniments, Ointments, Cream, Paste, Suppositories, Parenterals – Pressurized dosage forms – Packaging techniques.
UNIT III ADVANCED DRUG DELIVERY SYSTEMS
Controlled release dosage forms – Rationale – Principle and factor influencing – Design and Fabrication – Microencapsulation – Liposomes – Niosomes – Transdermal drug delivery – Ocular, Vaginal and Uterine controlled release.
UNIT IV BIOSIMILARS
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
Erythropoietin – Insulin – Somatotropin – Interleukin – Interferon – GMCSF – Blood clotting Factors – Tissue plasminogen activator – Monoclonal antibodies and engineered antibodies.
TOTAL: 45 PERIODS
OUTCOMES:
After completion of the course the students will be able to
CO1 Understand the legal steps involved in progressing a new drug to market. Grasping the current regulatory acts and safety norms of the modern pharmaceutical industries.
CO2 Acquire knowledge on novel biotechnological and pharmaceutical products, current medicines and their applications in therapeutic and diagnostic fields.
CO3 Have depth knowledge and understanding of current topical and newly emerging aspects of pharmaceutical biotechnology
CO4 Understand the biosimilars medicine and its future prospects
CO5 Understand the Pharmaceutical parameters for the current and future biotechnology related products on the market.
REFERENCES
1. Crommelin Dwan J.A., Robert D. Sindelar and Bernd Meibohm, “Pharmaceutical Biotechnology: Fundamentals and application”, Springer, 4th Edition, 2013.
2. Gary Walsh, “Pharmaceutical Biotechnology-Concepts and Application”, John Wiley and Sons Publishers, 1st Edition, 2007.
3. James Swarbrick, “Encyclopedia of Pharmaceutical Technology”, CRC Press, 4th Edition, 2013.
4. Shayne Cox Gad, “Pharmaceutical Manufacturing Handbook: Production and Processes”, Wiley, 2nd Edition, 2011.
5. Shein-Chung Chow, “Biosimilars: Design and Analysis of Follow-on Biologics”, CRC Press, 3rd Edition, 2013.