B.Pharm 7th Semester New Syllabus 2026-27

Biostatistics Research Methodology

(Theory – BP701T

UNIT-1: Basic concepts of biostatistics

• Definition, meaning and type of variables
  Data – Meaning and methods of data collection, data preprocessing and cleaning
  Population and sample, Importance of sampling, Sampling methods Probability and non-probability sampling
  o Probability sampling – Random, systematic, stratified, cluster sampling
  o Non-probability sampling – Convenience sampling, purposive sampling, snowball sampling
• Types of statistics –
  Descriptive statistics and inferential statistics
  Descriptive statistics – Meaning and types of descriptive statistics
• Frequency distribution, measures of central tendency
• Measures of dispersion – Range, variance and standard deviation.
  Concept of degrees of freedom, quartiles, skewness and kurtosis
  Diagrammatic representation of frequency distribution

• Probability and probability distributions- Classical probability and statistical probability
  Probability of union, intersection and complement of events, conditional probability, marginal probability
• Probability distributions- Meaning of a probability distribution
  Discrete probability distribution- Meaning and examples of discrete probability distribution, meaning of PMF
• Continuous probability distribution – Meaning and examples of normally distributed data, meaning of PDF
• Normal distribution – Meaning and characteristics of a normal distribution, parameters of a normal distribution, equation for PDF of a normal distribution. Pharmaceutical examples of data which can be modelled with Poisson Normal distribution.
• Standard normal distribution, Z transformation, reading the table of Z values
  Problems based on standard normal distribution, binomial and Poisson distributions
• Sampling distributions – Meaning of sampling distributions
• t distribution – the t statistic, equation for calculating t statistic, meaning of t distribution, meaning of degrees of freedom and their relevance to t distribution, reading and interpreting table of t values, applications of t distribution
• F distribution – the F statistic, equation for calculating F statistic, meaning of F distribution, reading and interpreting table of F values
• Chi square distribution – the Chi square statistic, meaning of chi square distribution, reading and interpreting the table of chi square values, applications of chi square distribution.

• Correlation analysis – Introduction to the concept of correlation between two variables, positive and negative correlation, no correlation, examples of positive, negative and no correlation
  Measurement of correlation –
• Pearson’s Correlation Co-efficient – Definition and formula, assumptions, range of Pearson’s correlation co-efficient, interpretation of sign and magnitude
• Spearman’s Rank Correlation Co- efficient – Concept and when to use, procedure for calculation Spearman’s Rank Correlation Coefficient.
• Real life applications in pharmaceutical and health sciences
• Problems on calculation of these two types of correlation co-efficient, use of scatter plot
  Multiple correlation – Concept and applications.
• Regression analysis – Concept of regression, dependent and independent variables in regression analysis, simple linear regression, simple linear regression equation (method of least squares), calculation of slope and intercept, co-efficient of determination, interpretation of output of regression analysis, applications of regression analysis. Relationship between regression co-efficient and correlation co-efficient
• Problems on simple linear regression analysis for predicting values of dependent variables (pharmaceutical examples) Multiple linear regression-Concept and applications, meaning of overfitting and underfitting.

• Statistical estimation – Point estimates and interval estimates of population parameters from sample statistics
• Concept of confidence intervals. Confidence intervals for means using t values. Problems on generating confidence intervals
• Hypothesis testing – Concept, steps involved, type I and type II error, sample size and power of
  the test, p values, applications of hypothesis testing Parametric tests – t- tests (single sample t test, two independent samples t test, paired t test) ANOVA (one way and two way).
• Assumptions, procedure and applications (case studies using t tests and ANOVA)
  Hypothesis testing in regression analysis and correlation
• Non-parametric tests – Mann Whitney U test, Wilcoxon Sign Rank test, Kruskal Wallis test,
  Friedman test, Chi square tests.
• Assumptions, procedure and applications (problems on non-parametric tests)

• Research – Meaning, importance and types.
• Types of research designs
• Research methodology – Based on the research question, selection of research design, defining the population and sample, selecting the sample size and sampling method, method of data collection and data analysis.
• Decision tree approach for selection of statistical tests on the basis of research question and type of data
• Descriptive research design – Examples of application Observational research design – Examples of application Experimental research design –Examples of application
• Scientific report writing, plagiarism, referencing styles, selection of research journals, abstracting services and databases
• Screening and Optimization – Concept and experimental designs used for screening and optimization including Plackett Burman design, factorial designs, D optimal design, sequential simplex design, central composite design and response surface methodology, blocking and confounding in experimental designs.

(Theory – BP702T)

UNIT-1:

• Cosmetics and cosmeceuticals, Classification of Cosmetics (Cosmetics and Cosmeceuticals for Skin Care, Hair Care, Oral Care, foot care, body cavities, Decorative Cosmetics, Cleansing cosmetics, Perfumes and Fragrances.)
• Types of various dosage forms for Cosmetics, Common excipients for cosmetic.

• Common skin problems (Dry Skin, Oily skin, Pimples and acne, Pigmentation, Prickly heat and Sun burn) and general composition, method for preparation, packing and evaluation of the skin
• Cosmetics and cosmeceuticals. Herbal cosmetics for skin.
• Types of soaps, syndet bars, general composition, method for preparation, packing and evaluation of soaps.
• Introduction to Perfumes and toiletries.

• Common Hair problems, Hair Cosmetics and cosmeceuticals: Types of shampoos, general composition, method for preparation, packing and evaluation of shampoos.
• Introduction to hair oils, hair serums, conditioners, hair colors, Depilatory and shaving products. Herbal hair care products.

• Various problems of oral cavity, Oral Cosmetics, and cosmeceuticals: general composition, method for preparation, packing and evaluation of mouth wash and toothpaste. Herbal oral care cosmetics.
• Types of Cosmetics for nails, eyes, body odor, lip care and cleansing.
• Intimate hygiene products for males and females.

• Role of Regulatory authorities for Cosmetics and cosmeceuticals (CDSCO and FDA). Cosmetics regulations 2020 and role of BIS.
• Role of certifying bodies like ECCERT and COSMOS in herbal cosmetics. Labeling requirement of cosmetics and Packaging of cosmetics.
• Testing as per BIS specification and analytical methods (including sensory test, sensitivity test).

(Theory – BP703T)

UNIT-1: AI in Pharmacokinetics & Dose Optimization

• Review of pharmacokinetic parameters (Cmax, Tmax, AUC, clearance)
• Modeling concentration-time relationships: Linear regression in
  PK data modeling, multiple regression for dose adjustment based on patient variables (age, weight, renal function)
• Interpretation of regression coefficients in clinical context
• Error metrics (RMSE, R²) in PK modeling
• Limitations of linear modeling in nonlinear pharmacokinetics

• Overview of pharmacovigilance systems
• Structure and data formats from real systems (e.g. FAERS, Eudra Vigilance)
• Conceptual overview of frequency analysis and signal detection
• Logistic regression for ADR risk prediction
• Confusion matrix and clinical performance metrics
• Sensitivity, specificity, precision, recall
• Bias and confounding in observational datasets

• Concept of precision medicine
• Patient covariates and therapeutic response
• Logistic regression for disease risk prediction
• Classification of responders vs non-responders
• Evaluation metrics in healthcare prediction
• Ethical implications of predictive modeling

• Structure of Electronic Health Records (EHR)
• AI in Clinical Decision Support Systems (CDSS)
• Regression models for outcome prediction
• Classification models for risk scoring
• Real-world data analytics
• Limitations of AI in clinical environments
• Accountability and interpretability

• Students will undertake a guided supervised learning project (individually or in groups) applying regression or classification models to pharmaceutical or clinical datasets.
• The project should include the following steps:
• Identification and definition of a relevant pharmaceutical or clinical problem
• Selection of an appropriate publicly available dataset
• Identification of predictor variables and outcome variables
• Data preprocessing and preparation for analysis
• Application of suitable supervised learning methods (e.g., linear regression or logistic regression)
• Evaluation of model performance using appropriate metrics
• Interpretation of results in the context of pharmaceutical or clinical relevance
• Discussion of limitations, potential biases, and ethical considerations
• Presentation of findings to faculty mentors or peers.
• Suggested project topics (not limited to):
• Dissolution rate prediction, tablet hardness prediction, stability degradation modelling, quality control batch failure prediction, assay variability modelling, impurity prediction, moisture impact on formulation stability, coating thickness prediction, solubility enhancement modelling, tablet defect classification, adverse drug reaction (ADR) prediction, therapeutic response prediction using patient datasets, hospital readmission risk prediction, dose requirement prediction using pharmacokinetic data, diabetes risk prediction from health markers, antibiotic treatment success prediction, ICU stay duration prediction, medication adherence analysis, and disease severity classification.

(Theory – BP704T)

UNIT-1:

• Nuclear Magnetic Resonance Spectroscopy: Principles of ¹H-NMR and ¹³C-NMR, various solvents used, chemical shift, factors affecting chemical shift, coupling constant, spin–spin coupling, relaxation, instrumentation of FT-NMR and its applications.
• Mass Spectrometry: Principles, fragmentation and its rules, ionization techniques – Electron impact, chemical ionization, MALDI, FAB, API, analyzers – Time of flight and quadrupole, ion trap, detectors and applications.

• 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.
• Thermal Analysis: Introduction, instrumentation, factors affecting measurements, applications of TGA, DSC (types) and DTA.

• UPLC and Nano LC: Principle, advantages over LC and applications.
• Principle and applications of hyphenated techniques: GC-MS, LCMS/MS, ICP-MS.
• Supercritical chromatography and flash chromatography: principles and applications.

• Green Analytical Chemistry: Types of green solvents, various computational tools used to assess
  the greenness and its applications in sample preparation and analytical method development.
• Bio-analytical Methods: Introduction to bioanalytical method development, extraction of drugs and metabolites from biological fluids – SPE, LLE, PPE, BCS classification, PK-PD interaction, microsomal assays, MTT assay, BA & BE study protocol, biosimilars.
• Radio Immune Assays and ELISA: Importance, various components, principle, different methods, limitations and applications of radio immunoassay and ELISA.

• Microscopy-Based Analytical Techniques: Principle, instrumentation, and applications of optical microscopy, scanning electron microscopy and transmission electron microscopy.

(Minimum 12 experiments must be performed)

1. Interpretation of Proton NMR spectra of known compound (any two)
2. Interpretation of Carbon NMR spectra of known compound (any two)
3. Interpretation of mass spectrum of known compound (any two)
4. Interpretation of X-Ray diffraction spectrum (any one)
5. Interpretation of DSC Thermogram (any one)
6. Preparation and Evaluation of Green Analytical Solvents
7. Analytical method development by using Green chemistry
8. Quantification of pharmaceuticals in biological fluids using Solid Phase Extraction (SPE)
9. Quantification of pharmaceuticals in biological matrix by PPE
10. Quantification of pharmaceuticals in biological matrix by LLE
11. Demonstration of Cell Viability evaluation using MTT Assay
12. Demonstration on residual solvent analysis using GC
13. Assay of drug using HPLC (any two)
14. Analysis of drug from biological fluid using HPLC/ UV spectroscopy.

(Theory – BP705T)

UNIT-1: Fundamentals of Pharmacovigilance

• a) Concept, history, and importance of pharmacovigilance
• b) Basic drug classification systems (introductory overview only):
• c) ATC classification, ICD
• ATC system
• ICD
  d) Drug-related problems and medication safety
  e) Drug safety considerations in special populations:
• Paediatrics
• Geriatrics
• Pregnancy and lactation

• a) Objectives and functions of pharmacovigilance
• b) Methods of pharmacovigilance data collection:
• Spontaneous reporting
• Cohort and case-control studies
  c) Global pharmacovigilance systems:
• WHO International Drug Monitoring Programme
• Role of CIOMS and major regulatory agencies (e.g., USFDA, EMA)
  d) Pharmacovigilance Programme of India (PvPI)
  e) Establishment and role of ADR Monitoring Centres

• a) Classification and types of ADRs
• b) Mechanisms and risk factors for ADRs
• c) Methods of ADR monitoring, detection, and reporting
• d) Assessment of causality, severity, predictability, and preventability of ADRs
• e) Management of ADRs
• f) Online reporting mechanisms and databases (WHO-ART, VigiBase, Vigiflow, Oracle Argus, OpenVigil software).
• g) MEDRA

• a) Definition, scope, and significance of immunovigilance, cosmetovigilance, nutraceutical-vigilance, materiovigilance, herbovigilance, ecopharmacovigilance, and hemovigilance
• b) Vaccination failure and vaccine pharmacovigilance (vaccinovigilance)
• c) Overview of adverse events following immunization (AEFIs)
• d) Immunization safety monitoring systems in India

• a) Risk evaluation and management strategies in pharmacovigilance and immunovigilance
• b) Communication in drug safety crisis management
• c) Communication with regulatory agencies, business partners, and healthcare facilities
• d) Analysis of real-world case studies and lessons learnt
• e) Emerging trends and challenges in pharmacovigilance and immunovigilance
• f) Overview of safety data generation
• g) Objectives of ICH guidelines
• h) Expedited and aggregate reporting
• i) Individual Case Safety Reports (ICSRs)
• j) Periodic Safety Update Reports (PSURs)
• k) Post-approval expedited reporting
• l) Good Clinical Practices (GCPs) regulation 2019
• m) Application of pharmacogenomics and pharmacometrics in pharmacovigilance.

(Theory – BP706T)

UNIT-1: Introduction to Pharmacy Practice

• Definition, scope and evolution of:
• Hospital and clinical pharmacy
• Pharmacist’s role from dispenser to healthcare provider
• WHO and FIP guidelines on pharmacy practice
• Pharmacy practice regulations in India
• Role of pharmacy in public health and policymaking
• Promoting rational use of medicines
• Concepts of Good Pharmacy Practice
• Pharmacy practice settings: inpatient, outpatient
• Concept of healthcare delivery system and interprofessional collaboration
• Primary (PHC), Secondary (CHC), Tertiary (District Hospitals, Medical Colleges) – role of pharmacists at various levels of care.

• Hospital and its Organization
• Classification of hospitals, organizational structure of a hospital, healthcare staff involved in hospital services and their functions
• Hospital Pharmacy and its Organization
• Definition, organization structure, location, layout, and staff requirements, responsibilities and functions of hospital pharmacists
• Pharmacy and Therapeutic Committee
• Organization, functions, and policies, drug inclusion into formulary, inpatient and outpatient prescriptions, automatic stop order, emergency drug list preparation
• Hospital Formulary
• Definition of hospital formulary, contents of hospital formulary, differentiation between hospital formulary and drug list, preparation and revision of hospital formulary
• Drug Distribution System in a Hospital
• Drug procurement and inventory control, dispensing of drugs to inpatients, types of drug distribution systems, charging policy and labeling, dispensing of drugs to ambulatory patients, dispensing of
• controlled drugs, outpatient medication dispensing, NABH standards for medication management in hospital settings
• Community Pharmacy
• Organization and structure of retail and wholesale drug stores, types and design of a drug store, legal requirements for establishment and maintenance of a drug store, dispensing of proprietary products,
• maintenance of records of retail and wholesale drug stores, prescription handling, labelling, and patient counselling, introduction, definition, sale, and OTC medication list, vaccination services

• Introduction to clinical pharmacy and its concept
• Drug therapy monitoring
  o Medication chart review
  o Clinical review
  o Pharmacist intervention
  o Ward round participation
  o Medication history
  o Pharmaceutical care
• Drug information services
• Drug/Medication related problems
• Drug and poison information services
• Therapeutic drug monitoring (TDM)

• Medication Adherence and Non-Adherence
• Definition
• Factors influencing non-adherence
• Pharmacist’s role in medication adherence
• Monitoring of patient medication adherence
• Tools used to assess medication adherence
• Strategies to overcome non-adherence
• Patient Counselling Techniques and Communication Skills
• Definition of patient counselling
• Steps involved in patient counselling
• Communication skills – communication with prescribers and patients
• Types of educational materials used in patient counselling
• Barriers to effective counselling – types and strategies to overcome barriers
• Health Screening Services
• Definition and importance
• Methods for screening:
• Blood pressure, Blood sugar, Body Mass Index, Lung function test
• Role of pharmacist in health screening services
• Telemedicine

• Prescribing Guidelines
• Pediatrics, geriatrics, pregnant and lactating women
• ISMP guidelines for high risk medicines
• Essential Drug Concept
• WHO definition
• Core principles and key features
• Procedure involved in adding a drug into the essential drug list
• Rational Use of Medications
• Antibiotics
• Antibiotic stewardship program
  Injections
  OTC drugs
  Consequences of irrational drug use.
• Dose calculations in chemotherapy, renal and hepatic failure patients.

(Theory – BP707T)

UNIT-1: Fundamentals of Regulatory Affairs

• Introduction to Drug Regulatory Affairs, Overview of regulatory authorities in India and major international markets (US FDA, EMA, PMDA), Role and responsibilities of Regulatory Affairs Professionals,
• Organizational structure of regulatory bodies.
• Basic regulatory terminologies: Guidance, Guidelines, Regulations, Laws, Acts.
• Regulatory reference resources: Orange Book, Purple Book, Federal Register, Code of Federal Regulations (CFR).

• Drug discovery and development process, Drug development teams and their functions.
• Non-clinical drug development: Pharmacology, Drug metabolism, Toxicology.
• Regulatory documentation: Investigational New Drug (IND) application, Investigator’s Brochure (IB), Clinical research protocols, Biostatistics in pharmaceutical product development, Bioequivalence (BE) studies, Data presentation for regulatory submissions.

• Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities: Organization and responsibilities, Regulatory requirements for import, manufacture, and sale of pharmaceuticals in India, Certificate of Pharmaceutical Product (COPP), Regulatory approval procedure for new drugs in India, Clinical trial regulatory requirements in India, phytopharmaceutical regulations, Good Clinical Practice (GCP) guidelines and Schedule Y, Innovator and generic drugs, Generic drug product development
• Phytopharmaceutical regulation by AYUSH and CDSCO.

• Types of regulatory applications: Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA)
• Drug Master Files (DMF), Common Technical Document (CTD), electronic CTD (eCTD), ASEAN CTD (ACTD),
• Registration procedure for Indian drug products in overseas markets, Post-approval changes to NDA and ANDA.

• Clinical research phases (I-IV), Clinical trial documents, Institutional Review Board (IRB) and Independent Ethics Committee (IEC): Formation and functions
• Informed consent process and documentation, Good Clinical Practice (GCP) obligations of investigators, sponsors, and monitors, Management and monitoring of clinical trials, Pharmacovigilance: Safety monitoring during clinical trials and post- marketing

BP710RP Research Project

ELECTIVE SUBJECTS

BP708T AEC (ACTIVITY ENHANCING COURSE) THEORY

Current Good Manufacturing Practices (cGMP)

(Theory – BP708T AEC1)

UNIT-1: Standard Operating Procedures (SOP), Systems for Training & Development in Pharmaceuticals

• Introduction to SOPs, SOP on SOP, Contents of a standard SOP, Writing a good SOP, Distribution and control of SOPs.
• Introduction to Training and development, Training needs identification, Training and evaluation.

• List of major guidelines referred in pharmaceuticals
• Effectively reading and understanding the guidelines

• Introduction to Quality Management Systems (QMS), Manufacturing Assurance, Analytical Assurance, Developments
  Quality Assurance, Engineering Assurance.
• Concepts of corrective and preventive actions (CAPA), Deviations and Incidents handling.
• Handling of non-conforming materials

• Introduction to complaints, Types of complaints
• Understanding Manufacturing defects and Quality issues
• Handling and investigation of customer complaints

• Introduction to audits and Types of audits.
• Preparation for a successful audit, Audit teams and internal audits.
• Handling of FDA inspections: FDA observations, Compliance and replying to an audit report.

Pharmaceutical Automation

(Theory – BP708T AEC2)

UNIT-1: Introduction to Automation in Pharmaceuticals

• Definition and scope of automation in pharmaceutical industry
• Importance and benefits: accuracy, efficiency, cost-effectiveness, compliance
• Types of automation: fixed, programmable, flexible
• Application areas: production, packaging, quality control, warehousing
• Challenges and limitations of automation

• Principles of automated tablet compression, capsule filling, liquid filling, and coating machines
• PLC-based machinery in granulation and drying
• Robotics in sterile product manufacturing (isolators, RABS)
• Continuous manufacturing vs. batch processing
• Automation in aseptic processing and lyophilization

• Sensors and transducers: temperature, pressure, flow, pH, conductivity
• Introduction to SCADA (Supervisory Control and Data
  Acquisition) systems
• Distributed Control Systems (DCS) in pharma
• Process Analytical Technology (PAT) – definition and applications
• Basics of automation programming (ladder diagrams, logic gates – overview only)

• Automation in analytical laboratories: HPLC, UV, FTIR, dissolution testers
• Laboratory Information Management System (LIMS)
• Integration of instruments with software and data loggers
• Automated sampling and testing methods
• Role of AI/ML in predictive quality assurance

• Regulatory expectations: USFDA, WHO, EMA on automation & electronic systems
• 21 CFR Part 11 – electronic records and signatures
• Data integrity and ALCOA
• Emerging trends: IoT, Industry 4.0, cloud-based manufacturing, AI in pharma
• Case studies: automated systems in top pharma companies

Modern Techniques in Cellular Biology

(Theory – BP708T AEC3)

UNIT-1: CRISPR & Genome Editing

• CRISPR-Cas9 mechanics, guide-RNA design and DNA repair outcomes, contrasts knock-outs, knock-ins and base-editing, and shows how dCas fusions enable gene activation or repression. Students compare delivery routes—plasmid, ribonucleoprotein, viral and lipid-nanoparticle—then evaluate off-target detection strategies before a mini-lab in which they design a gRNA and screen predicted off-targets.

• Learners review flow-cytometer fluidics, optics and fluorochrome chemistry, interpret forward/side scatter plots for cell size and granularity, and build multi-colour antibody panels with compensation. They perform
• cell-cycle, apoptosis and immunophenotyping assays, study FACS sorting logic and viability checks, and finish with a hands-on run of a four-colour immunophenotyping panel.

• This unit covers phase-contrast, DIC and fluorescence time-lapse microscopy, stressing environmental control through on-stage incubators and microfluidic perfusion. Students deploy fluorescent reporters such as
• GFP fusions and calcium biosensors to track motility, division and signalling, learn to minimise phototoxicity and manage large image datasets, then conduct a 12-hour GFP-cell time-lapse demo.

• Participants examine single-cell isolation by droplets, microwells or FACS, walk through barcoding, library preparation and sequencing, and run a basic bioinformatics pipeline for quality control, normalisation, clustering and UMAP/t-SNE visualisation. They identify cell types, trajectories and rare populations, glimpse CITE-seq and spatial transcriptomics, and explore a public scRNA-seq dataset in R/Python during a workshop.

• Confocal and two-photon fundamentals, followed by super-resolution strategies—STED, SIM and PALM/STORM—plus functional techniques such as FRET, FRAP and FLIM for probing protein interactions and dynamics. Learners plan multiplexed staining with spectral imaging, discuss clinical applications including FISH and diagnostic immunofluorescence, and acquire and process a confocal z-stack in a practical sessions.

Medical Devices

(Theory – BP708T AEC4)

UNIT-1: Introduction to Medical Devices: History and Overview of Medical Device Industry and evolving market Trends

• (India + WW)
• GOI’s initiatives and National Medical Device Policy.
• Regulatory frameworks (CDSCO; State FDA; USFDA; EU-CE, etc.)
• Medical device design and development process
• Definition and Classification of Medical Devices (India; US; EU)

• Medical Device Design principles and methodologies, safety analysis
• Properties and selection of materials & biomaterials for devices
• Tissue engineering and regenerative medicine
• Biocompatibility Testing and Standards (ISO 10993)

• Good Manufacturing Practices (GMP) & Infrastructure requirements
• Quality assurance and quality control in Medical Devices
• Supply chain management (warehousing distribution)
• Risk Management (ISO 14971)

• Medical device regulations and standards (IMDR 2017)
• Understanding Regional Differences in Regulatory Pathways
• Regulatory submissions and approvals (India)
• Post-market surveillance and vigilance (India)
• Global Regulatory Requirements (USFDA, CE Mark, etc.)
• Case Studies of Global Regulatory Challenges

• Principles of biomedical sensors and transducers
• Medical imaging techniques (X-ray, CT, MRI, ultrasound)
• Telemedicine and remote monitoring
• Integration of Electronics and Software in Medical Devices
• Wearable Devices and Remote Monitoring
• Ethical issues in device development and use

Transformation of Food Waste into Medicinal Products

(Theory – BP708T AEC5)

UNIT-1: Introduction to Food Waste

• Food waste: Definition, Types, Sources, Causes, Problems, Impacts Advantages, Challenges, Solutions and Future directions Indian and International regulations for food waste management

• Principles of Food waste Management
• Technologies and Processes: Thermo-chemical Processes, Biological Processes, Green extraction, Pyrolytic and
• Enzymatic techniques

• Production of Biohydrogen, Biogas, Organic acids, Vermicompost, and Biopolymers

• Antimicrobial, Antioxidants, Anti-inflammatory agents, Antibiotics, Prebiotics, Nutritional Supplements,
• Cosmetics and Biopolymers
• 3D printed medicines: Customized dosages and Scaffolds

• Machine learning, Internet of Things (IoT) and Blockchain

Biosimilars, Vaccines & Macromolecules

(Theory – BP708T AEC6)

UNIT-1: Introduction to Biosimilars, Vaccines and Macromolecules

• Classes: Monoclonal antibodies (mAbs), cytokines, insulin, growth factors; primary/secondary/tertiary structures.
• Biosimilars: Definition, rationale, types (e.g., erythropoietin, filgrastim).
• Vaccines: Generations (live, subunit, viral vector, mRNA); adjuvants and delivery systems.
• Industry landscape: Blockbuster biologics (Humira, Keytruda), Indian biosimilar market.

• Physicochemical: SDS-PAGE, SEC-HPLC, peptide mapping, mass spectrometry.
• Glycosylation analysis: N-linked glycans (HILIC, lectin arrays).
• Functional assays: Cell-based potency, binding ELISA, ADCC.
• Comparability for biosimilars: Fingerprinting (ICH Q5E).

• Upstream: Cell line development (CHO, HEK), bioreactors, media optimization.
• Downstream: Harvesting, chromatography (affinity, ion-exchange), viral clearance.
• Fill-finish: Lyophilization, aseptic processing, cold chain.
• Process analytical technology (PAT) in biologics.

• Release testing: Host cell proteins (HCP), DNA, sterility, endotoxin (LAL).
• Stability: ICH Q5C for biologics; subvisible particles, aggregation.
• Immunogenicity assessment: ADA assays, neutralizing antibodies.
• Vaccine QC: Potency, identity, safety (animal models).

• Global: USFDA 351(k) biosimilar pathway, EMA guidelines, WHO prequalification.
• India: CDSCO Biosimilar Guidelines 2021, DCGI vaccine approvals.
• Documentation: BLA/CMC modules, PK/PD comparability studies.
• Case studies: COVID-19 mRNA vaccines (Pfizer), Indian trastuzumab biosimilars.

• Definition and scope of precision medicine
• Evolution from “one-size-fits-all” to personalized approaches
• Key components: genomics, epigenetics, environmental factors, lifestyle
• Role of pharmacists in precision medicine
• Interdisciplinary nature (clinicians, bioinformaticians, pharmacologists)

• Basic human genetics relevant to pharmacy
• Genotype-phenotype relationships
• Genetic polymorphisms: CYP450 enzymes (CYP2D6, CYP2C9, etc.)
• FDA drug labelling and pharmacogenomic biomarkers
• Tools/databases: AlphaGenome, PharmGKB, CPIC, SNPedia

• Types of biomarkers: predictive, prognostic, diagnostic
• Role of biomarkers in targeted therapy
• Companion diagnostics: regulatory approval and clinical application
• Case study: Trastuzumab and HER2 testing in breast cancer
• Lab-on-chip and biosensor technologies
• Targeted nano-delivery in oncology
• Antibody-drug conjugates (ADCs)
• Smart delivery systems (stimuli-responsive biosensors)

UNIT-4: Technology, AI, and Big Data in Precision Medicine

• Role of AI, machine learning, and data analytics in precision medicine
• Electronic Health Records (EHRs), clinical decision support systems
• Integration of genomic data with patient profiles
• Examples of AI-driven drug discovery
• Data security and interoperability

• Regulatory guidelines (US FDA, EMA, CDSCO) for genomic-based therapies
• Clinical trial design for precision drugs
• Cost-effectiveness and access in low-resource settings
• Ethical issues: genetic testing, informed consent, data ownership
• Future of pharmacy practice in the precision medicine era