8 Sem Pharmacy Syllabus PDF

Scheme of Evaluation Bachelor of Pharmacy (B. Pharm.) Semester VIII Effective from the Session 2020-2021...

Scheme of Evaluation Bachelor of Pharmacy (B. Pharm.) Semester VIII Effective from the Session 2020-2021 Internal Assessment End Semester Exams Course No. of Hours/ Total Credit Points Code Name of the Course Continuous Sessional Exams Marks wk Total Marks Duration Mode Marks Duration BP801T Biostatistics and Research 3 4 10 15 1 Hr 25 75 3 Hrs 100 Methodology BP802T Social and Preventive Pharmacy 3 4 10 15 1 Hr 25 75 3 Hrs 100 BP803ET Pharma Marketing Management* BP804ET Pharmaceutical Regulatory Science* BP805ET Pharmacovigilance* 10 + 10 15 + 15 = 1+1= 25 + 25 = 75 + 75 3+3=6 100 4+4= BP806ET Quality Control and 3+3= 6 = 20 30 2 Hrs 50 = 150 Hrs +100 8 Standardization of Herbal* =200 BP807ET Computer Aided Drug Design* BP808ET Cell and Molecular Biology* BP809ET Cosmetic Science* BP810ET Experimental Pharmacology* BP811ET Advanced Instrumentation Techniques* BP812ET Dietary Supplements and Nutraceuticals* BP813ET Pharmaceutical Product Development* BP814PW Project Work (On Elective) 12 - - - - 150 4 Hrs 150 6 BP815P Report on Industrial Tour** - - - - - 100 - 100 2 Total 24 40 60 4 Hrs 100 550 16 Hrs 650 24 *(ET: Elective subject) Every candidate has to opt for two of the elective subjects, and has to carry out project on any one of them. **The Industrial Tour may be performed at the end of the 7th semester. SEMESTER VIII  BP801T. BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory) 45 Hours Scope: To understand the applications of Biostatics in Pharmacy. This subject deals with descriptive statistics, Graphics, Correlation, Regression, logistic regression Probability theory, Sampling technique, Parametric tests, Non-Parametric tests, ANOVA, Introduction to Design of Experiments, Phases of Clinical trials and Observational and Experimental studies, SPSS, R and MINITAB statistical software’s, analysing the statistical data using Excel. Objectives: Upon completion of the course the student shall be able to: Know the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of Experiment). Know the various statistical techniques to solve statistical problems. Appreciate statistical techniques in solving the problems. Course content: Unit-I 10 Hours Introduction: Statistics, Biostatistics, Frequency distribution. Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical problems. Correlation: Definition, Karl Pearson’s coefficient of correlation, multiple correlation- Pharmaceuticals examples. Unit-II 10 Hours Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x = a + by, Multiple regression, standard error of regression– Pharmaceutical examples. Probability: Definition of probability, Binomial distribution, Normal distribution, Poisson’s distribution, properties– problems. Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis, sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard error of mean (SEM) - Pharmaceutical examples. Parametric test: t-test (Sample, Pooled or Unpaired and Paired), ANOVA, (One way and Two way), Least Significance difference.  Unit-III 10 Hours Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal- Wallis test, Friedman Test. Introduction to Research: Need for research, Need for design of Experiments, Experiential Design Technique, Plagiarism. Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph Designing the methodology: Sample size determination and Power of a study, Report writing and presentation of data, Protocol, Cohorts studies, Observational studies, Experimental studies, Designing clinical trial, various phases. Unit-IV 8 Hours Blocking and confounding system for Two-level factorials. Regression modeling: Hypothesis testing in Simple and Multiple regression models Introduction to Practical components of Industrial and Clinical Trials Problems: Statistical Analysis Using Excel, SPSS, MINITAB®, Design of experiment, R- Online Statistical Software’s to Industrial and Clinical trial approach. Unit-V 7 Hours Design and Analysis of experiments: Factorial Design: Definition, 22, 23design. Advantages of factorial design. Response Surface methodology: Central composite design, Historical design, Optimization Techniques. Recommended Books (Latest edition): Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton, publisher Marcel Dekker Inc. New York. Fundamental of Statistics – Himalaya Publishing House- S.C. Guptha. Design and Analysis of Experiments –PHI Learning Private Limited, R. Pannerselvam. Design and Analysis of Experiments– Wiley Students Edition, Douglas and C. Montgomery.  BP802T. SOCIAL AND PREVENTIVE PHARMACY (Theory) 45 Hours Scope: The purpose of this course is to introduce to students a number of health issues and their challenges. This course also introduced a number of national health programmes. The roles of the pharmacist in these contexts are also discussed. Objectives: After the successful completion of this course, the student shall be able to: Acquire high consciousness/realization of current issues related to health and pharmaceutical problems within the country and worldwide. Have a critical way of thinking based on current healthcare development. Evaluate alternative ways of solving problems related to health and pharmaceutical issues. Course content: Unit-I 10 Hours Concept of health and disease: Definition, concepts and evaluation of public health. Understanding the concept of prevention and control of disease, social causes of diseases and social problems of the sick. Social and health education: Food in relation to nutrition and health, Balanced diet, Nutritional deficiencies, Vitamin deficiencies, Malnutrition and its prevention. Sociology and health: Socio cultural factors related to health and disease, Impact of urbanization on health and disease, Poverty and health. Hygiene and health: personal hygiene and health care; avoidable habits. Unit-II 10 Hours Preventive medicine: General principles of prevention and control of diseases such as cholera, SARS, Ebola virus, influenza, acute respiratory infections, malaria, chicken guinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer, drug addiction-drug substance abuse. Unit-III 10 Hours National health programs, its objectives, functioning and outcome of the following: HIV AND AIDS control programme, TB, Integrated disease surveillance program (IDSP), National leprosy control programme, National mental health program, National programme for prevention and control of deafness, Universal immunization programme, National programme for control of blindness, Pulse polio programme.  Unit-IV 08 Hours National health intervention programme for mother and child, National family welfare programme, National tobacco control programme, National Malaria Prevention Program, National programme for the health care for the elderly, Social health programme; role of WHO in Indian national program. Unit-V 07 Hours Community services in rural, urban and school health: Functions of PHC, Improvement in rural sanitation, national urban health mission, Health promotion and education in school. Recommended Books (Latest edition): Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd Edition, 2010, ISBN: 9789380704104, JAYPEE Publications. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Roy Rabindra Nath, Saha Indranil, 4th Edition, 2013, ISBN: 9789350901878, JAYPEE Publications. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6th Edition, 2014, ISBN: 9789351522331, JAYPEE Publications. Essentials of Community Medicine—A Practical Approach, Hiremath Lalita D, Hiremath Dhananjaya A, 2nd Edition, 2012, ISBN: 9789350250440, JAYPEE Publications. Park Textbook of Preventive and Social Medicine, K Park, 21st Edition, 2011, ISBN- 14: 9788190128285, Banarasidas Bhanot Publishers. Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad. Sociology for Pharmacist by Kevin Taylor, Sarah Nettleton and Geoffery Harding. Recommended Journals: Research in Social and Administrative Pharmacy, Elsevier, Ireland.  BP803ET. PHARMA MARKETING MANAGEMENT (Theory) 45 Hours Scope: The pharmaceutical industry not only needs highly qualified researchers, chemists and, technical people, but also requires skilled managers who can take the industry forward by managing and taking the complex decisions which are imperative for the growth of the industry. The Knowledge and Know-how of marketing management groom the people for taking a challenging role in Sales and Product management. Objective: The course aims to provide an understanding of marketing concepts and techniques and their applications in the pharmaceutical industry. Course content: Unit-I 10 Hours Marketing: Definition, general concepts and scope of marketing, distinction between marketing & selling. Marketing environment. Industry and competitive analysis. Analysing consumer buying behaviour and industrial buying behaviour. Pharmaceutical market: Quantitative and qualitative aspects; size and composition of the market; demographic descriptions and socio-psychological characteristics of the consumer; market segmentation & targeting. Consumer profile; Motivation and prescribing habits of the physician; patient's choice of physician and retail pharmacist. Analysing the Market; Role of market research. Unit-II 10 Hours Product decision: Classification, product line and product mix decisions, product life cycle, product portfolio analysis; product positioning; New product decisions; Product branding, packaging and labeling decisions, Product management in pharmaceutical industry. Unit-III 10 Hours Promotion: Methods, determinants of promotional mix, promotional budget; An overview of personal selling, advertising, direct mail, journals, sampling, retailing, medical exhibition, public relations, online promotional techniques for OTC Products.  Unit-IV 08 Hours Pharmaceutical marketing channels: Designing channel, channel members, selecting the appropriate channel, conflict in channels, physical distribution management: Strategic importance, tasks in physical distribution management. Professional sales representative (PSR): Duties of PSR, purpose of detailing, selection and training, supervising, norms for customer calls, motivating, evaluating, compensation and future prospects of the PSR. Unit-V 07 Hours Pricing: Meaning, importance, objectives, determinants of price; pricing methods and strategies, issues in price management in pharmaceutical industry. An overview of DPCO (Drug Price Control Order) and NPPA (National Pharmaceutical Pricing Authority). Emerging concepts in marketing: Vertical & Horizontal Marketing; Rural Marketing; Consumerism; Industrial Marketing; Global Marketing. Recommended Books: (Latest Editions) Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India, New Delhi. Walker, Boyd and Larreche: Marketing Strategy- Planning and Implementation, Tata MC GrawHill, New Delhi. Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill. Arun Kumar and N Meenakshi: Marketing Management, Vikas Publishing, India. Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition). Ramaswamy, U.S & Nanakamari, S: Marketing Management: Global Perspective, Indian Context, Macmillan India, New Delhi. Shanker, Ravi: Service Marketing, Excel Books, New Delhi. Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel Publications. Pharmaceutical marketing in India by Subba Rao Chaganti.  BP804ET. PHARMACEUTICAL REGULATORY SCIENCE (Theory) 45Hours Scope: This course is designed to impart the fundamental knowledge on the regulatory requirements for approval of new drugs, and drug products in regulated markets of India & other countries like US, EU, Japan, Australia, UK etc. It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products. Objectives: Upon completion of the subject student shall be able to: Know about the process of drug discovery and development. Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals. Know the regulatory approval process and their registration in Indian and international markets. Course content: Unit-I 10 Hours New Drug Discovery and development Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development. Unit-II 10 Hours Regulatory Approval Process Approval processes and timelines involved in Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an approved NDA / ANDA. Regulatory authorities and agencies Overview of regulatory authorities of India, United States, European Union, Australia, Japan, Canada (Organization structure and types of applications). Unit-III 10 Hours Registration of Indian drug product in overseas market Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD)research. Unit-IV 08 Hours Clinical trials  Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee - formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials. Unit-V 07 Hours Regulatory Concepts Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book. Recommended books (Latest edition): Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences, Vol. 185. Informa Health care Publishers. New Drug Approval Process: Accelerating Global Registrations by Richard A Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol. 190. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by Douglas J. Pisano, David Mantus. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143 Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Rozovsky and Rodney K. Adams Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P. Ognibene Drugs: From Discovery to Approval, Second Edition by Rick Ng. Intellectual Property Rights in Pharmaceutical Industry Theory and practice by Bayya Subba Rao and Appaji.  BP805ET. PHARMACOVIGILANCE (Theory) 45 hours Scope: This paper will provide an opportunity for the student to learn about development of pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme in an organization, various methods that can be used to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases and adverse drug reactions. Objectives: At completion of this paper it is expected that students will be able to (know, do, and appreciate): Why drug safety monitoring is important? History and development of pharmacovigilance. National and international scenario of pharmacovigilance. Dictionaries, coding and terminologies used in pharmacovigilance. Detection of new adverse drug reactions and their assessment. International standards for classification of diseases and drugs. Adverse drug reaction reporting systems and communication in pharmacovigilance. Methods to generate safety data during pre-clinical, clinical and post approval phases of drugs’ life cycle. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning. CIOMS requirements for ADR reporting. Writing case narratives of adverse events and their quality. Course Content Unit-I 10 Hours Introduction to Pharmacovigilance History and development of Pharmacovigilance Importance of safety monitoring of Medicine WHO international drug monitoring programme Pharmacovigilance Program of India (PvPI). Introduction to adverse drug reactions Definitions and classification of ADRs Detection and reporting Methods in Causality assessment Severity and seriousness assessment Predictability and preventability assessment, Management of adverse drug reactions. Basic terminologies used in pharmacovigilance Terminologies of adverse medication related events, Regulatory terminologies. Unit-II 10 hours Drug and disease classification Anatomical, therapeutic and chemical classification of drugs International classification of diseases Daily defined doses International Non-proprietary names for drugs. Drug dictionaries and coding in pharmacovigilance WHO adverse reaction terminologies MedDRA and Standardised MedDRA queries WHO drug dictionary EudraVigilance medicinal product dictionary. Information resources in pharmacovigilance Basic drug information resources Specialised resources for ADRs. Establishing pharmacovigilance programme Establishing in a hospital Establishment & operation of drug safety department in industry, Contract Research Organisations (CROs) Establishing a national programme. Unit-III 10 Hours Vaccine safety surveillance Vaccine Pharmacovigilance Vaccination failure, Adverse events following immunization. Pharmacovigilance methods Passive surveillance – Spontaneous reports and case series Stimulated reporting Active surveillance– Sentinel sites, drug event monitoring and registries Comparative observational studies– Cross sectional study, case control study and cohort study. Targeted clinical investigations. Communication in pharmacovigilance Effective communication in Pharmacovigilance Communication in Drug Safety Crisis management Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media. Unit-IV 8 Hours Safety data generation: Pre clinical phase, Clinical phase, Post approval phase (PMS) ICH Guidelines for Pharmacovigilance: Organization and objectives of ICH, Expedited reporting, Individual case safety reports, Periodic safety update reports, Post approval expedited reporting, Pharmacovigilance planning, Good clinical practice in pharmacovigilance studies Unit-V 7 Hours Pharmacogenomics of adverse drug reactions: Genetics related ADR with example focusing PK parameters.  Drug safety evaluation in special population: Paediatrics, Pregnancy and lactation, Geriatrics CIOMS: CIOMS Working Groups CIOMS Form. CDSCO (India) and Pharmacovigilance: D & C Act and Schedule Y, Differences in Indian and global pharmacovigilance requirements. Recommended Books (Latest edition): Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers. Quintessence of Pharmacovigilance: Tapan Kumar Chatterjee, PharmaMed Press. Practical Drug Safety from A to Z by Barton Cobert, Pierre Biron, Jones and Bartlett Publishers. Mann's Pharmacovigilance: Elizabeth B. Andrews, Nicholas, Wiley Publishers. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers. An Introduction to Pharmacovigilance: Patrick Waller, Wiley Publishers. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert, Jones & Bartlett Publishers. Textbook of Pharmaco-epidemiology edited by Brian L. Strom, Stephen E Kimmel, Sean Hennessy, Wiley Publishers. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills: G. Parthasarathi, Karin Nyfort Hansen, Milap C. Nahata. National Formulary of India. Text Book of Medicine by Yashpal Munjal. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn 3=7297 http://www.ich.org/ http://www.cioms.ch/ http://cdsco.nic.in/ http://www.who.int/vaccine_safety/en/ http://www.ipc.gov.in/PvPI/pv_home.html  BP806ET. QUALITY CONTROL AND STANDARDIZATION OF HERBALS (Theory) 45 Hours Scope: In this subject the student learns about the various methods and guidelines for evaluation and standardization of herbs and herbal drugs. The subject also provides an opportunity for the student to learn cGMP, GAP and GLP in traditional system of medicines. Objectives: Upon completion of the subject student shall be able to: Know WHO guidelines for quality control of herbal drugs. Know Quality assurance in herbal drug industry. Know the regulatory approval process and their registration in Indian and international markets. Appreciate EU and ICH guidelines for quality control of herbal drugs. Course Content Unit-I 10 hours Basic tests for drugs– Pharmaceutical substances, Medicinal plants materials and dosage forms. WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude drugs intended for use. Unit-II 10 hours Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in traditional system of medicine. WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines WHO Guidelines on GACP for Medicinal Plants. Unit-III 10 hours EU and ICH guidelines for quality control of herbal drugs. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines. Unit-IV 08 hours  Stability testing of herbal medicines. Application of various chromatographic techniques in standardization of herbal products. Preparation of documents for new drug application and export registration GMP requirements and Drugs & Cosmetics Act provisions. Unit-V 07 Hours Regulatory requirements for herbal medicines. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems Comparison of various Herbal Pharmacopoeias. Role of chemical and biological markers in standardization of herbal products. Recommended Books: (Latest Editions) Pharmacognosy by Trease and Evans. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002. Pharmacognosy by Kokate, Purohit and Gokhale. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I, Carrier Pub., 2006. Aggarwal, S.S., Herbal Drug Technology. Universities Press, 2002. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal Products. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO Regional office for the Western Pacific, Manila, 1998. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd Ed. World Health Organization, Geneva, 1981. WHO. Quality Control Methods for Medicinal Plant Materials. World Health Organization, Geneva, 1999. WHO. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health Organization, Geneva, 2005. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. World Health Organization, Geneva, 2004.  BP807ET. COMPUTER AIDED DRUG DESIGN (Theory) 45 Hours Scope: This subject is designed to provide detailed knowledge of rational drug design process and various techniques used in rational drug design process. Objectives: Upon completion of the course, the student shall be able to understand: Design and discovery of lead molecules. The role of drug design in drug discovery process. The concept of QSAR and docking. Various strategies to develop new drug like molecules. The design of new drug molecules using molecular modeling software. Course Content: UNIT-I 10 Hours Introduction to Drug Discovery and Development: Stages of drug discovery and development. Lead discovery and Analogue Based Drug Design: Rational approaches to lead discovery based on traditional medicine, Random screening, Non-random screening, serendipitous drug discovery, lead discovery based on drug metabolism, lead discovery based on clinical observation. Analogue Based Drug Design: Bioisosterism, Classification, Bioisosteric replacement. Any three case studies. UNIT-II 10 Hours Quantitative Structure Activity Relationship (QSAR) SAR versus QSAR, History and development of QSAR, Types of physicochemical parameters, experimental and theoretical approaches for the determination of physicochemical parameters such as Partition coefficient, Hammet’s substituent constant and Taft’s steric constant. Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like COMFA and COMSIA. UNIT-III 10 Hours Molecular Modeling and virtual screening techniques: Virtual Screening techniques: Drug likeness screening, Concept of pharmacophore mapping and pharmacophore based Screening,  Molecular docking: Rigid docking, flexible docking, manual docking, Docking based screening. De novo drug design. UNIT-IV 08 Hours Informatics & Methods in drug design: Introduction to Bioinformatics, chemoinformatics. ADME databases, chemical, biochemical and pharmaceutical databases. UNIT-V 07 Hours Molecular Modeling: Introduction to molecular mechanics and quantum mechanics. Energy Minimization methods and Conformational Analysis, global conformational minima determination. Recommended Books (Latest Editions) Robert GCK, ed., “Drug Action at the Molecular Level” University Prak Press Baltimore. Martin YC. “Quantitative Drug Design” Dekker, New York. Delgado JN, Remers WA eds “Wilson & Gisvold’s Text Book of Organic Medicinal & Pharmaceutical Chemistry” Lippincott, New York. Foye WO “Principles of Medicinal chemistry ‘Lea & Febiger. Koro lkovas A, Burckhalter JH. “Essentials of Medicinal Chemistry” Wiley Interscience. Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry” John Wiley & Sons, New York. Current Concepts in Drug Design by T. Durai and Ananda Kumar. Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University Press. Smith HJ, Williams H, eds, “Introduction to the principles of Drug Design” Wright Boston. Silverman R.B. “The Organic Chemistry of Drug Design and Drug Action” Academic Press, New York.  BP808ET. CELL AND MOLECULAR BIOLOGY (Theory) 45 Hours Scope: Cell biology is a branch of biology that studies cells – their physiological properties, their structure, the organelles they contain, interactions with their environment, their life cycle, division, death and cell function. This is done both on a microscopic and molecular level. Cell biology research encompasses both the great diversity of single- celled organisms like bacteria and protozoa, as well as the many specialized cells in multi-cellular organisms such as humans, plants, and sponges. Objectives: Upon completion of the subject student shall be able to: Summarize cell and molecular biology history. Summarize cellular functioning and composition. Describe the chemical foundations of cell biology. Summarize the DNA properties of cell biology. Describe protein structure and function. Describe cellular membrane structure and function. Describe basic molecular genetic mechanisms. Summarize the Cell Cycle. Course content: Unit-I 10 Hours Cell and Molecular Biology: Definitions theory and basics and Applications. Cell and Molecular Biology: History and Summation. Properties of cells and cell membrane. Prokaryotic versus Eukaryotic. Cellular Reproduction. Chemical Foundations – an Introduction and Reactions (Types). Unit-II 10 Hours DNA and the Flow of Molecular Information. DNA Functioning. DNA and RNA. Types of RNA. Transcription and Translation. Unit-III 10 Hours  Proteins: Defined and Amino Acids. Protein Structure. Regularities in Protein Pathways. Cellular Processes. Positive Control and significance of Protein Synthesis. Unit-IV 08 Hours Science of Genetics. Transgenics and genomic analysis. Cell cycle analysis. Mitosis and meiosis. Cellular Activities and checkpoints. Unit-V 07 Hours Cell Signals: Introduction. Receptors for Cell Signals. Signaling Pathways: Overview. Misregulation of Signaling Pathways. Protein-Kinases: Functioning. Recommended Books (latest edition): W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications, Oxford London. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors, Delhi. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of Recombinant DNA: ASM Press Washington D.C. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill Ed. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology. Rose: Industrial Microbiology. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution. Peppler: Microbial Technology. Edward: Fundamentals of Microbiology. N.K. Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi Bergey’s manual of systematic bacteriology, Williams and Wilkins- A Waverly company RA Goldshy et. al.: Kuby Immunology.  BP809ET. COSMETIC SCIENCE (Theory) 45 Hours Unit-I 10 Hours Classification of cosmetic and cosmeceutical products. Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs. Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients, preservatives. Classification and application Skin: Basic structure and function of skin. Hair: Basic structure of hair. Hair growth cycle. Oral Cavity: Common problem associated with teeth and gums. Unit-II 10 Hours Principles of formulation and building blocks of skin care products: Face wash, Moisturizing cream, Cold Cream, Vanishing cream and their advantages and disadvantages. Application of these products in formulation of cosmeceuticals. Antiperspirants & deodorants- Actives & mechanism of action. Principles of formulation and building blocks of Hair care products: Conditioning shampoo, Hair conditioner, anti-dandruff shampoo. Hair oils. Chemistry and formulation of para phenylenediamine based hair dye. Principles of formulation and building blocks of oral care products: Toothpaste for bleeding gums, sensitive teeth. Teeth whitening, Mouthwash. Unit-III 10 Hours Sun protection, Classification of Sunscreens and SPF. Role of herbs in cosmetics: Skin Care: Aloe and turmeric. Hair care: Henna and amla. Oral care: Neem and clove. Analytical cosmetics: BIS specification and analytical methods for shampoo, skin- cream and toothpaste. Unit-IV 08 Hours Principles of Cosmetic Evaluation: Principles of sebumeter, corneometer. Measurement of TEWL, Skin Colour, Hair tensile strength, Hair combing properties. Soaps and syndet bars. Evolution and skin benefits.  Unit-V 07 Hours Oily and dry skin, causes leading to dry skin, skin moisturisation. Basic understanding of the terms Comedogenic, dermatitis. Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causes Cosmetic problems associated with skin: blemishes, wrinkles, acne, prickly heat and body odour. Antiperspirants and Deodorants- Actives and mechanism of action. Recommended Books (latest edition): Harry’s Cosmetology, Wilkinson, Moore, Seventh Edition, George Godwin. Poucher’s Perfumes, Cosmetic & Soaps by Poucher W.A., Butler, H., Springer India Pvt. Ltd, New Delhi. Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th Edition, Vandana Publications Pvt. Ltd., Delhi. Text book of cosmetology by Sanju Nanda & Roop K. Khar, Tata Publishers. Cosmeceuticals by Madhusudan Rao. Cosmetics: Science and technology by Balsam M.S., Sagarin, E., Wiley Interscience, New York. Handbook of Cosmetic science and Technology by Pave M., Basel, A.O., Maibach H.I., Informa Healthcare, New York. Cosemeceuticals by Rao Y.N., Shayeda, PharmaMed Press, Hyderabad.  BP810ET. PHARMACOLOGICAL SCREENING METHODS (Theory) 45 Hours Scope: This subject is designed to impart the basic knowledge of preclinical studies in experimental animals including design, conduct and interpretations of results. Objectives: Upon completion of the course the student shall be able to: Appreciate the applications of various commonly used laboratory animals. Appreciate and demonstrate the various screening methods used in preclinical research. Appreciate and demonstrate the importance of biostatistics and research methodology. Design and execute a research hypothesis independently. Course content: Unit-I 10 Hours Laboratory Animals: Study of CPCSEA and OECD guidelines for maintenance, breeding and conduct of experiments on laboratory animals, Common lab animals: Description and applications of different species and strains of animals. Popular transgenic and mutant animals. Techniques for collection of blood and common routes of drug administration in laboratory animals, Techniques of blood collection and euthanasia. Unit-II 10 Hours Preclinical screening models Introduction: Dose selection, calculation and conversions, preparation of drug solution/suspensions, grouping of animals and importance of sham negative and positive control groups. Rationale for selection of animal species and sex for the study. Study of screening animal models for: Diuretics, nootropics, anti-Parkinson’s, anti-asthmatics, Preclinical screening models: for CNS activity- analgesic, antipyretic, anti- inflammatory, general anaesthetics, sedative and hypnotics, antipsychotic, antidepressant, antiepileptic, antiparkinsonism, Alzheimer’s disease. Unit-III 10 Hours  Preclinical screening models: for ANS activity, sympathomimetics, sympatholytics, parasympathomimetics, parasympatholytics, skeletal muscle relaxants, drugs acting on eye, local anaesthetics. Unit-IV 08 Hours Preclinical screening models: for CVS activity – anti-hypertensives, diuretics, antiarrhythmic, anti-dyslipidemic, anti-aggregatory, coagulants, and anticoagulants. Preclinical screening models for other important drugs like antiulcer, anti-diabetic, anticancer and anti-asthmatics. Unit-V 07 Hours Research methodology and Bio-statistics: Selection of research topic, review of literature, research hypothesis and study design. Pre-clinical data analysis and interpretation using Students ‘t’ test and One-way ANOVA. Graphical representation of data. Recommended Books (latest edition): Fundamentals of experimental Pharmacology by M.N. Ghosh. Hand book of Experimental Pharmacology by S.K. Kulkarni. CPCSEA guidelines for laboratory animal facility. Drug discovery and Evaluation by Vogel H.G. Drug Screening Methods by Suresh Kumar Gupta and S.K. Gupta. Introduction to biostatistics and research methods by PSS Sundar Rao and J Richard.  BP811ET. ADVANCED INSTRUMENTATION TECHNIQUES (Theory) 45 Hours Scope: This subject deals with the application of instrumental methods in qualitative and quantitative analysis of drugs. This subject is designed to impart advanced knowledge on the principles and instrumentation of spectroscopic and chromatographic hyphenated techniques. This also emphasizes on theoretical and practical knowledge on modern analytical instruments that are used for drug testing. Objectives: Upon completion of the course the student shall be able to: Understand the advanced instruments used and its applications in drug analysis. Understand the chromatographic separation and analysis of drugs. Understand the calibration of various analytical instruments. Know analysis of drugs using various analytical instruments. Course Content: Unit-I 10 Hours Nuclear Magnetic Resonance spectroscopy Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical shift, coupling constant, Spin - spin coupling, relaxation, instrumentation and applications. Mass Spectrometry- Principles, Fragmentation, Ionization techniques- Electron impact, chemical ionization, MALDI, FAB, Analysers -Time of flight and Quadrupole, instrumentation, applications. Unit-II 10 Hours Thermal Methods of Analysis: Principles, instrumentation and applications of Thermogravimetric Analysis (TGA), Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC). X-Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X-ray Crystallography, rotating crystal technique, single crystal diffraction, powder diffraction, structural elucidation and applications. Unit-III 10 Hours Calibration and validation- as per ICH and USFDA guidelines.  Calibration of following Instruments: Electronic balance, UV-Visible spectrophoto- meter, IR spectrophotometer, Fluorimeter, Flame Photometer, HPLC and GC. Unit-IV 08 Hours Radio immune assay: Importance, various components, Principle, different methods, Limitation and Applications of Radio immuno assay. Extraction techniques: General principle and procedure involved in the solid phase extraction and liquid-liquid extraction. Unit-V 07 Hours Hyphenated techniques- LC-MS/MS, GC-MS/MS, HPTLC-MS. Recommended Books (Latest Editions) Instrumental Methods of Chemical Analysis by B.K Sharma. Organic spectroscopy by Y.R Sharma. Text book of Pharmaceutical Analysis by Kenneth A. Connors. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake. Organic Chemistry by I.L. Finar. Organic spectroscopy by William Kemp. Quantitative Analysis of Drugs by D. C. Garrett. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi. Spectrophotometric identification of Organic Compounds by Silverstein.  BP812ET. DIETARY SUPPLEMENTS AND NUTRACEUTICALS (Theory) 45 Hours Scope: This subject covers foundational topic that are important for understanding the need and requirements of dietary supplements among different groups in the population. Objective: This module aims to provide an understanding of the concepts behind the theoretical applications of dietary supplements. By the end of the course, students should be able to: Understand the need of supplements by the different group of people to maintain healthy life. Understand the outcome of deficiencies in dietary supplements. Appreciate the components in dietary supplements and the application. Appreciate the regulatory and commercial aspects of dietary supplements including health claims. Course Content: Unit-I 10 Hours Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classification of Nutraceuticals, Health problems and diseases that can be prevented or cured by Nutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis, hypertension etc. Public health nutrition, maternal and child nutrition. Nutrition and ageing, nutrition education in community. Source, Name of marker compounds and their chemical nature, Medicinal uses and health benefits of following used as nutraceuticals/functional foods: Spirulina, Soybean, Ginseng, Garlic, Broccoli, Gingko, Flaxseeds. Unit-II 10 Hours Phytochemicals as nutraceuticals: Occurrence and characteristic features (chemical nature medicinal benefits) of following: Carotenoids: α and β-Carotene, Lycopene, Xanthophylls, leutin. Sulfides: Diallyl sulfides, Allyl trisulfide. Polyphenolics: Reservetrol. Flavonoids: Rutin, Naringin, Quercitin, Anthocyanidins, catechins, Flavones. Prebiotics/Probiotics: Fructo-oligosaccharides, Lacto bacillum. Phyto estrogens: Isoflavones, daidzein, Geebustin, lignans. Tocopherols.  Proteins, vitamins, minerals, cereal, vegetables and beverages as functional foods: oats, wheat bran, rice bran, sea foods, coffee, tea and the like. Unit-III 10 Hours Introduction to free radicals: Free radicals, reactive oxygen species, production of free radicals in cells, damaging reactions of free radicals on lipids, proteins, Carbohydrates, nucleic acids. Dietary fibres and complex carbohydrates as functional food ingredients. Unit-IV 08 Hours Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion injury, Cancer, Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage, muscle damage. Free radicals involvement in other disorders. Free radicals theory of ageing. Antioxidants: Endogenous antioxidants– enzymatic and non-enzymatic antioxidant defence, Superoxide dismutase, catalase, Glutathione peroxidase, Glutathione, Vitamin C, Vitamin E, α-Lipoic acid, melatonin. Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy Anisole. Functional foods for chronic disease prevention. Unit-V 07 Hours Effect of processing, storage and interactions of various environmental factors on the potential of nutraceuticals. Regulatory Aspects: FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food Safety. Adulteration of foods. Pharmacopeial Specifications for dietary supplements and nutraceuticals. Recommended Books (Latest editions) Dietetics by Sri Lakshmi. Role of dietary fibres and nutraceuticals in preventing diseases by K.T. Agusti and P. Faizal: BS Publication. Advanced Nutritional Therapies by Cooper. K.A., (1996). The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988). Prescription for Nutritional Healing by James F. Balch and Phyllis A. Balch 2nd Ed., Avery Publishing Group, NY (1997). G. Gibson and C. Williams Editors 2000 Functional foods Woodhead Publ. Co. London. Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York. Labuza, T.P. 2000, Functional Foods and Dietary Supplements: Safety, Good Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional Foods M.K. Sachmidl and T.P. Labuza eds. Aspen Press.  Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition). Shils, M.E., Olson, J.A., Shike, M. 1994 Modern Nutrition in Health and Disease. Eighth edition. Lea and Febiger. BP813ET. PHARMACEUTICAL PRODUCT DEVELOPMENT (Theory) 45 Hours Unit-I 10 Hours Introduction to pharmaceutical product development, objectives, and regulations related to preformulation, formulation development, stability assessment, manufacturing and quality control testing of different types of dosage forms. Unit-II 10 Hours An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories: Solvents and solubilizers. Cyclodextrins and their applications. Non - ionic surfactants and their applications. Polyethylene glycols and sorbitols. Suspending and emulsifying agents. Semi solid excipients. Unit-III 10 Hours An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories: Tablet and capsule excipients. Directly compressible vehicles. Coat materials. Excipients in parenteral and aerosols products. Excipients for formulation of NDDS. Selection and application of excipients for pharmaceutical formulations, with specific industrial applications. Unit-IV 08 Hours Optimization techniques in pharmaceutical product development. A study of various optimization techniques for pharmaceutical product development with specific examples. Optimization by factorial designs and their applications. A study of QbD and its application in pharmaceutical product development.  Unit-V 07 Hours Selection and quality control testing of packaging materials for pharmaceutical product development- regulatory considerations. Recommended Books (Latest editions) Pharmaceutical Statistics Practical and Clinical Applications by Stanford Bolton, Charles Bon; Marcel Dekker Inc. Encyclopaedia of Pharmaceutical Technology, edited by James Swarbrick, Third Edition, Informa Healthcare publishers. Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman and Leon Lachman; Marcel Dekker, Inc. The Theory and Practice of Industrial Pharmacy, Fourth Edition, edited by Roop K Khar, S P Vyas, Farhan J Ahmad, Gaurav K Jain; CBS Publishers and Distributors Pvt. Ltd. 2013. Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by Patrick J. Sinko, BI Publications Pvt. Ltd. Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and R. K. Khar, CBS Publishers and Distributors Pvt. Ltd, First Edition 2012. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lloyd V. Allen Jr., Nicholas B. Popovich, Howard C. Ansel, 9th Ed. 40 Aulton’s Pharmaceutics – The Design and Manufacture of Medicines, Michael E. Aulton,3rd Ed. Remington – The Science and Practice of Pharmacy, 20th Ed. Pharmaceutical Dosage Forms – Tablets Vol 1 to 3, A. Liebermann, Leon Lachman and Joseph B. Schwartz. Pharmaceutical Dosage Forms – Disperse Systems Vol 1 to 3, H.A. Liberman, Martin, M.R and Gilbert S. Banker. Role of Dietary Fibres and Nutraceuticals in Preventive Diseases by KT Augusti et. Al. Pharmaceutical Dosage Forms – Parenteral Medication Vol 1 & 2, Kenneth E. Avis and H.A. Liebermann. Advanced Review Articles related to the topics.  BP814PW PROJECT WORK (On Elective) All the students shall undertake a project under the supervision of a teacher and submit a report. The area of the project shall directly relate any one of the elective subjects opted by the student in semester VIII. The project shall be carried out in group not exceeding 5 in number. The project report shall be submitted in triplicate (typed & bound copy not less than 25 pages).  BP815P. REPORT ON INDUSTRIAL TOUR Visit of students to an industrial establishment or an approved research laboratory. The industrial/ research laboratory visit shall include: in case of industry- visit to different sections and subsections of the industry, an idea about the functioning of the industry, product range of the industry and various approvals of the industry; in case of research laboratory- visit to different departments of the laboratory, an idea about the interdisciplinary coordination, contribution of the laboratory to the society and various approvals of the laboratory. A proper report of the same shall be submitted by the students, which shall be subsequently evaluated to assess the impact of the visit. May be performed at the end of the 7th semester.