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BP801T. BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)
Unit-I
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 correlationPharmaceuticals examples.
Unit-II
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
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
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
Design and Analysis of experiments:
Factorial Design: Definition, 22,23
design. Advantages of factorial design.
Response Surface methodology: Central composite design, Historical design, Optimization
Techniques.
BP802T. SOCIAL AND PREVENTIVE PHARMACY (Theory)
Unit-I
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
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
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
BP803ET. PHARMA MARKETING MANAGEMENT (Theory)
Unit-I
Marketing:
Definition, general concepts and scope of marketing, distinction between marketing & selling.
Marketing environment. Industry and competitive analysis. Analyzing 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
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
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
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
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.
BP804ET. PHARMACEUTICAL REGULATORY SCIENCE (Theory)
Unit-I
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
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
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
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
Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal
Register, Code of Federal Regulatory, Purple book
BP805ET. PHARMACOVIGILANCE (Theory)
Unit-I
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
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 Standardized MedDRA queries, WHO
drug dictionary, EudraVigilance medicinal product dictionary.
Information resources in pharmacovigilance
Basic drug information resources, Specialized resources for ADRs.
Establishing pharmacovigilance programme
Establishing in a hospital, Establishment & operation of drug safety department in industry,
Contract Research Organizations (CROs), Establishing a national program.
Unit-III
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
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
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.
BP806ET. QUALITY CONTROL AND STANDARDIZATION OF HERBALS
(Theory)
Unit-I
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
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
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines.
Unit-IV
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
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.
BP807ET. COMPUTER AIDED DRUG DESIGN (Theory)
UNIT-I
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
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
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
Informatics & Methods in drug design:
Introduction to Bioinformatics, chemoinformatics. ADME databases, chemical, biochemical and
pharmaceutical databases.
UNIT-V
Molecular Modeling: Introduction to molecular mechanics and quantum mechanics. Energy
Minimization methods and Conformational Analysis, global conformational minima
determination.
BP808ET. CELL AND MOLECULAR BIOLOGY (Theory)
Unit-I
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
DNA and the Flow of Molecular Information. DNA Functioning.
DNA and RNA. Types of RNA. Transcription and Translation.
Unit-III
Proteins: Defined and Amino Acids. Protein Structure.
Regularities in Protein Pathways.
Cellular Processes.
Positive Control and significance of Protein Synthesis.
Unit-IV
Science of Genetics.
Transgenics and genomic analysis. Cell cycle analysis.
Mitosis and Meiosis.
Cellular Activities and checkpoints.
Unit-V
Cell Signals: Introduction. Receptors for Cell Signals.
Signaling Pathways: Overview.
Misregulation of Signaling Pathways.
Protein-Kinases: Functioning.
BP809ET. COSMETIC SCIENCE (Theory)
Unit-I
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
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
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
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
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
BP810ET. PHARMACOLOGICAL SCREENING METHODS (Theory)
Unit-I
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
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
Preclinical screening models: for ANS activity, sympathomimetics, sympatholytics,
parasympathomimetics, parasympatholytics, skeletal muscle relaxants, drugs acting on eye, local
anaesthetics.
Unit-IV
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
Research methodology and Bio-statistics:
Selection of research topic, review of literature, research hypothesis and study design. Preclinical data analysis and interpretation using Students ‘t’ test and One-way ANOVA. Graphical
representation of data.
BP811ET. ADVANCED INSTRUMENTATION TECHNIQUES (Theory)
Unit-I
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, Analyzers -Time of flight and Quadrupole, instrumentation,
applications.
Unit-II
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
Calibration and validation- as per ICH and USFDA guidelines.
Calibration of following Instruments: Electronic balance, UV-Visible spectrophotometer, IR
spectrophotometer, Fluorimeter, Flame Photometer, HPLC and GC.
Unit-IV
Radio immune assay: Importance, various components, Principle, different methods, Limitation
and Applications of Radio immunoassay.
Extraction techniques: General principle and procedure involved in the solid phase extraction
and liquid-liquid extraction.
Unit-V
Hyphenated techniques– LC-MS/MS, GC-MS/MS, HPTLC-MS.
BP812ET. DIETARY SUPPLEMENTS AND NUTRACEUTICALS (Theory)
Unit-I
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
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
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
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, αLipoic acid, melatonin.
Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy
Anisole.
Functional foods for chronic disease prevention.
Unit-V
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.
BP813ET. PHARMACEUTICAL PRODUCT DEVELOPMENT (Theory)
Unit-I
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
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
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
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
Selection and quality control testing of packaging materials for pharmaceutical product
development- regulatory considerations.