Drug Design and Discovery detailed syllabus for Biotechnology & Biochemical Engineering (BBE) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BBE 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 & Biochemical Engineering 5th Sem scheme and its subjects, do visit BBE 5th Sem 2021 regulation scheme. For Professional Elective-III scheme and its subjects refer to BBE Professional Elective-III syllabus scheme. The detailed syllabus of drug design and discovery is as follows.
Course Objectives:
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Unit I
DRUG AND THEIR INTERACTION 9
Introduction to Drugs: Drug nomenclature, Routes of drug administration and dosage forms, Principles of Pharmacokinetics and Pharmacodynamics: ADME, Bioavailability of drugs -Lipinski’s rule; How drugs work -Drug targets, drug-target interaction and dose-response Relationships.
Unit II
DRUG DESIGN PIPELINE 9
New Drug Discovery & Development: Overview of new drug discovery, development, cost and time lines. Target Identification & Validation. Lead Discovery: Rational and irrational approaches -Drug repurposing, Natural products, High-throughput screening (HTS), Combinatorial chemistry and computer aided drug design (CADD)
Unit III
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Unit IV
DRUG TOXICITY, ASSAYS AND TESTING 9
Preclinical Testing of New Drugs: Pharmacology -In vitro/in vivo Pharmacokinetics and
Pharmacodynamics testing; Toxicology-Acute, chronic, carcinogenicity and reproductive toxicity testing; Drug formulation testing. Clinical Trial Testing of New Drugs: Phase I, Phase II and Phase III testing; Good clinical practice (GCP) guidelines -Investigators brochures, Clinical trial protocols and trial design;Ethical issues in clinical trials -How are patient rights protected?
Unit V
DRUG REGULATORY AGENCIES 9
US Food & Drug Administration (US FDA) and Central Drugs Standard Control Organization (CDSCO), India. Regulatory Applications & New Drug Approval: Investigational new drug (IND) application & New drug application (NDA); Regulatory review and approval process. Regulatory Requirements for Drug Manufacturing: Current Good manufacturing practice (cGMP) and GMP manufacturing facility inspection & approval.
Course Outcomes:
The students will be able to
- Will be able to describe the process of drug discovery and development
- Will be able to discuss the challenges faced in each step of the drug discovery process
- Will be able to gaine a basic knowledge of computational methods used in drug discovery
- Will be able to organise information into a clear report
- be able to demonstrate their ability to work in teams and communicate scientific information effectively
- Will be familiar with the Construct, review and evaluate preclinical and clinical pharmaceutical studies with a general understanding of aim, choice of procedures, results, conclusions and Importance.
Text Books:
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Reference Books:
- Intellectual Property Rights In India: General Issues And Implications by Prankrishna Pal. Publisher: Deep & Deep Publications Pvt.Ltd (2008)
- Stromgaard, Kristian, Povl Krogsgaard-Larsen, and Ulf Madsen. Textbook of drug design and discovery. CRC Press, 2009.
- Katzung, Bertram G., Susan B. Masters, and Anthony J. Trevor. Basic and Clinical Pharmacology (LANGE Basic Science). McGraw-Hill Education, 2012.
- Spriet, Alain, et al. Methodology of clinical drug trials. Basel: Karger, 1994.
For detailed syllabus of all the other subjects of Biotechnology & Biochemical Engineering 5th Sem, visit BBE 5th Sem subject syllabuses for 2021 regulation.
For all Biotechnology & Biochemical Engineering results, visit Anna University BBE all semester results direct link.