B.Pharm 6th Semester New Syllabus 2026-27

Advanced Pharmacognosy

(Theory – BP601T)

UNIT-1: Reverse Pharmacology and Integrative Approaches

• Reverse pharmacology and integrative approaches from the AYUSH perspective.
• Ethnopharmacological approach to bioprospecting. Traditional medicine databases: AYUSH Research Portal, ICMR Standards on Indian Medicinal Plants, TKDL, NAPRALERT, Super Natural, etc. Molecular docking and ADMET screening of bioactives. Concept of adjuvant therapy with herbals in metabolic and non-communicable diseases.

• Introduction to metabolomics and its tools: applications of NMR and HRMS in metabolomics, Metabolomics profiling and dereplication studies, Role of metabolomics in quality control, scientific, validation of traditional claims and pharmacological evaluation, Network pharmacology and systems biology approaches to herbal medicine, Significance of spectral libraries and chemoinformatics databases in drug discovery

• Role of artificial intelligence (AI), Machine learning and big data in Drug discovery from natural Products. Molecular docking, Virtual Screening and Pharmacophore modelling, Use of Genomic and transcriptomic tools in medicinal plant research, High-throughput screening (HTS) and bioautography.

• Bioactivity Guided Fractionation, characterization /Structure Elucidation, Optimization of lead compounds for better efficacy, safety, and stability through SAR and QSAR modelling for semi-synthetic compounds of Salicin, Artemisinin, Piperine, Papaverine and Andrographolides.
• Preclinical, Clinical Evaluation and New Drug approvals: Testing for toxicity as per OECD guidelines, pharmacokinetics, and bioavailability of herbal products, extracts and lead compounds, assessment of safety and
• efficacy, clinical trials with or without placebo for clinical endpoints based on assessment of quality of life reporting adverse events if any, filing IND application, NDA submission, Regulatory review and post marketing surveillance.

• Key Terminologies and Concepts: Definitions and distinctions: Patent, Intellectual Property Rights (IPR) Farmers’ Rights and Breeders’ Rights, Bioprospecting and Biopiracy Patenting Aspects of Natural Products and
• Traditional Knowledge: Legal frameworks and challenges in patenting natural substances, Traditional Knowledge Digital Library (TKDL) and its role in protecting indigenous knowledge.
• Role of National Biodiversity Authority in patenting natural products and NAGOYA protocol.
• Case Studies: Turmeric– U.S. patent on wound healing and its revocation, Neem– Biopiracy issue and patent cancellation.

Biopharmaceutics and Pharmacokinetics

(Theory – BP602T)

UNIT-1: Introduction to Biopharmaceutics and pharmacokinetics

• Introduction to various Pharmacokinetic parameters (using Plasma drug Concentration vs Time curve) and Pharmacodynamic parameters and drug delivery index.
• Absorption; Mechanisms of drug absorption through GIT, Physicochemical, Biological and Dosage form related factors influencing drug absorption though GIT, methods of Assessment of GIT absorption, Distribution Tissue permeability of drugs, binding of drugs, apparent volume of drug distribution, plasma and tissue protein binding of drugs, factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein binding of drugs.

• Drug metabolism and basic understanding of metabolic pathways renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, non renal routes of drug excretion of drugs
• Bioavailability and Bioequivalence: Definition and Objectives of bioavailability, absolute and relative bioavailability, Introduction to BCS and biopharmaceutical drug disposition classification system, methods of measurement of bioavailability (Plasma data, Urinary excretion data), Protocol for assessment of bioavailability and bioequivalence studies. invitro drug dissolution methods (test apparatus I-VII), biorelevant dissolution mediums, in-vitro in-vivo correlations: Concept and Applications, Biowaivers, Methods of enhancement of bioavailability.

• Compartment Models: Definition, Basis of classification, Properties of compartment, Advantages and disadvantages of compartment modelling. Kinetic considerations of One compartment open model. (a). Intravenous Injection (Bolus/rapid) (b). Intravenous infusion and (c) Extra-vascular administration. (with emphasis on Curve Fitting, Wagner–Nelson, Loo Riegelman)
• Introduction to non – compartment model: Principles, estimation of PK parameters (AUC, AUMC, MRT, MAT statistical moment theory).

• Multiple dosage regimen: dosing interval, drug accumulation, loading dose, maintenance dose, PK Parameters Kinetic consideration of two compartment open model (a) Intravenous Injection (Bolus/rapid) and (b) Extra vascular administrations (oral administration).
• Kinetics of multiple dosing, steady state drug levels, calculation of loading and maintenance doses and their clinical significance. Multiple dosage regimen.
• Introduction to pharmacokinetic consideration of Modified release drug products.

• Introduction, Reasons for Non-linearity, Michaelis-menton method of estimating parameters, Explanation with example of drugs.
• Application of PK software: Introduction of various in -silico methods for calculating various PK parameters.

(Practical – BP608P)

1. To calculate MRT from the given data.
2. To assess the effect of protein binding of a drug
3. To report relative bioavailability of given drug product using urinary excretion data
4. To report relative bioavailability of given drug product using plasma data
5. Establish IVIVC from the given in vitro and in vivo data.
6. To calculate pharmacokinetic parameters of a drug using given plasma level data.
7. To report bioequivalence of drug products using given urinary excretion data administered
8. To calculate absorption rate constant, elimination rate constant and elimination half-life of given excretion data by sigma minus method.
9. To calculate absorption rate constant, elimination rate constant and elimination half-life of the given drug data administered by IV bolus injection represented by one compartment model.
10. To calculate the absorption rate constant by using curve fitting method.
11. To calculate various pharmacokinetic parameters using in silico methods.
    *PCI recommended software’s shall be used for performing experiments.

Intellectual Property Rights

(Theory – BP603T)

UNIT-1: Introduction to Intellectual Property

• Definition and scope of Intellectual Property (IP), Importance and types of IP: Patents, Trademarks, Copyrights and Trade Secrets, Overview of the origin and progression of intellectual property rights in India and internationally, Role of IP in the pharmaceutical industry

• Definition and objectives of patents, Criteria for patentability such as Novelty/innovations, Non-obviousness, Utility, Types of patents and nonpatentable inventions in India, Procedure for filing a patent in India, Rights of a patent holder and term of patent protection

• Overview of Indian Patent Act, 1970 (latest amendments and key provisions under the act), TRIPS Agreement and its implications on the Indian pharmaceutical sector, Compulsory licensing, patent opposition, and revocation, Indian pharmaceutical patents: Case studies.

• Trademarks, Copyrights, Industrial designs: Definition, importance, registration process, Basics and protection in scientific work, Importance and legal framework, Trade secrets and geographical indications in pharma industry

• Valuation and strategies for commercialization of intellectual property; processes of technology transfer, licensing agreements, and collaborative ventures; issues related to IP infringement and available legal remedies; management practices of IPR in the pharmaceutical industry supported by relevant case studies.

AI applications in Pharmaceutical Sciences

(Theory – BP604T)

UNIT-1: AI in Natural Products & Pharmacognostic Data Modeling Overview of ML applications in natural products

• Representation of crude drug data (morphological, microscopic, phytochemical, chromatographic features)
• Structuring herbal datasets for predictive modeling
• Classification models for authentication of crude drugs (authentic vs adulterated)
• Regression models for prediction of secondary metabolite yield
• Application of AI in phytochemical screening and prioritization
• Herb-drug interaction prediction using database-driven approaches
• Limitations of predictive modeling in natural products.

• Overview of the role of AI applications in pharmaceutical chemistry with focus on drug discovery concepts:
• Conversion of molecular structures into numerical descriptors (MW, logP, HBD/HBA, TPSA)
• Structured chemical datasets and QSAR modeling
• Regression and classification models for predicting biological activity (IC₅₀, solubility, ADMET properties), toxicities.
• Virtual screening and lead optimization concepts
• Limitations of ML models and importance of chemical reasoning

• Overview of AI models across formulation development stages, with emphasis on the applications and limitations:
• Overview of dosage form development and formulation variables
• Machine learning in formulation optimization and excipient selection
• Regression modeling for solubility and bioavailability enhancement
• Time-concentration modeling for drug release interpretation
• Stability study design and modeling degradation trends
• Shelf-life estimation using regression-based approaches
• Practical limitations of extrapolation in formulation science

• Overview of introduces multivariate analysis in pharmaceutical analytical techniques with focus on the different models and their applications:
• Digital data acquisition in pharmaceutical production
• Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
• Correlation analysis for identifying process variability
• Logistic regression models for batch pass/fail prediction
• Feature importance in process monitoring, predictive maintenance concepts.
  Ethical and regulatory considerations in automated decisionmaking, and limitations of predictive models in manufacturing environments.

• Overview of multivariate analysis in pharmaceutical analytical techniques with focus on the different models and their applications:
• Introduction to chemometrics and multivariate analytical data
• Spectroscopic data modeling (UV/IR interpretation)
• Regression analysis in quantitative pharmaceutical analysis
• Chromatographic peak modeling and interpretation
• Classification models for genuine vs counterfeit detection
• Handling noise and variability in analytical datasets
• Limitations of AI models in analytical decision-making

Pharmaceutical Analysis

(Theory – BP605T)

UNIT-1: Electrochemical Methods of analysis

• Potentiometry: Electrode potential, electrochemical cell, construction and working of reference and indicator electrodes including membrane electrodes, measurement of potential and pH, potentiometric titrations, methods of detecting end point and Karl Fischer titration.
• Conductometry: Introduction, conductivity cell, conductometric titrations and applications.
• Polarography: Introduction, residual current, migration current, diffusion current and limiting current, DME,
  polarographic wave, Ilkovic’s equation (Statement Only), and applications.

• Fundamentals of Spectroscopy: Properties of electromagnetic radiation, electromagnetic spectrum.
• UV Visible spectroscopy: Beer and Lambert’s law, Derivation and deviations. Electronic transitions, chromophores,
  auxochromes, spectral shifts, solvent effect on absorption spectra, Instrumentation – Sources of radiation, wavelength selectors, sample cells, detectors (Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode). Applications – single and multi component analysis of pharmaceuticals.
• IR spectroscopy: Introduction, fundamental modes of vibrations in poly atomic molecules, factors affecting vibrations, Instrumentation of dispersive Infrared spectrophotometer (including sample handling Techniques) and FTIR.
• Pharmaceutical applications.

• Theory, luminescence, factors affecting fluorescence, quenching. Instrumentation and pharmaceutical applications.
• Flame Photometry and Atomic Absorption Spectrometry: Theory, nebulisation, flame and flame temperature, interferences, instrumentation and pharmaceutical applications.
• Nepheloturbidometry: Principle, instrumentation and applications.

• Principle, various stationary and mobile phases, diverse development and detection techniques and applications of column, paper and thin layer chromatography.
• Ion-exchange chromatography: Introduction, principles, types of ions exchange resins, factors affecting ion exchange, methodology and applications.
• Gel filtration and affinity chromatography: Principles and applications.
• Electrophoresis: Introduction, factors affecting electrophoretic mobility, Techniques of paper, gel, capillary electrophoresis, applications.

• Gas chromatography: Introduction, theory, instrumentation, derivatization, temperature programming, advantages, disadvantages and applications
• High performance liquid chromatography: Introduction, theory, instrumentation, advantages and applications.
• HPTLC: Principle, instrumentation and applications.

(Practical – BP609P)

(Minimum 12 experiments must be performed)

1. Determination of the endpoint of a acid base titration by potentiometric method.
2. Determination of end point of acid base titrations by conductometry.
3. Determination of absorption maxima and effect of solvents on absorption maxima of organic compounds
4. Assay of APIs by colorimetry.
5. Assay of single component by UV- Spectrophotometer.
6. Simultaneous estimation of multicomponent formulations by UV spectrophotometer.
7. Identification of various functional groups in official compounds by FTIR as per IP.
8. Assay of quinine sulphate by fluorimetry
9. Determination of quenching effect by fluorimetry
10. Assay of sodium chloride by flame photometry
11. Assay of potassium chloride by flame photometry
12. Determination of chlorides and sulphates by nephelo turbidometry
13. Separation of amino acids by paper chromatography
14. Separation of mixture of components by thin layer chromatography
15. Demonstration experiment on GC
16. Determination of official compounds by HPLC (anyone)
17. Demonstration experiment on HPTLC.

Pharmaceutical Jurisprudence

(Theory – BP606T)

UNIT-1: Drugs and Cosmetics Act, 1940 and its rules 1945

• Objectives, Definitions, Legal definitions of schedules to the Act and Rules, CDSCO guidelines for Import & export of Pharmaceuticals
• Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.

• Detailed study of Schedule G, H, H1, M, N, P, T, U, V, X, Y, Sch F, Part XII B.
• Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties
• Labeling & packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties.
• Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling authorities, Drugs Inspectors

• Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations including ER20, State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties
• Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations, Offences and Penalties.
• Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives, Definitions, Authorities and Officers, Constitution and Functions of narcotic &Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production of poppy straw, manufacture, sale and export of opium, Offences and Penalties

• Study of Salient Features of Drugs and Magic Remedies Act and its rules: Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties
• Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional Animal Ethics Committee, CCSEA guidelines for Breeding and Stocking of Animals, Performance of Experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties
• National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)- 2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled formulations, National List of Essential Medicines (NLEM).

• Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee
• Code of Pharmaceutical ethics: Definition, Pharmacist in relation to his job, trade, medical profession and his profession,
• Medical Termination of Pregnancy Act
• Brief Introduction to Right to Information Act
• Introduction New Drugs and Clinical Trials Rules, 2019 and amendments.
• Cosmetic rules 2020
• Regulatory guidelines on similar biologics.
• Overview of Medical Device Regulations, Guidelines on Probiotics, Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

INTERNSHIP (MANDATORY) – BP612I

ELECTIVE SUBJECTS

ACITIVITY ENHANCING COURSE (AEC) THEORY

* Only 1 Theory course shall be selected from below subjects

Green Chemistry

(Theory – BP607T AEC1)

UNIT-1: Introduction to Green Chemistry in Pharmacy

• Definition and scope of green chemistry in pharmaceutical sciences
• Principles of Green Chemistry with pharmaceutical examples

• Comparison of traditional vs. green chemical approaches in drug synthesis
• Environmental impact of pharmaceutical manufacturing
• Overview of pharmaceutical pollutants and their life cycle
• Metrics: Atom economy, E-factor, Process Mass Intensity (PMI)

• Green Solvents and use of green solvents (e.g. water, supercritical fluids, ionic liquids) in drug synthesis
• Solvent-free reactions in pharmaceutical synthesis
• Green Catalysis and Reaction Enhancement in pharmaceutical green chemistry – Overview of catalysis in pharmaceutical green chemistry, Photochemical Transformations, Phase Transfer Catalysis

• Microwave assisted reactions: Merit and demerits of its use
• Mechanism, superheating effects of microwave
• Effects of solvents in microwave assisted synthesis
• Microwave technology in process optimization
• Applications in various organic reactions and heterocycles synthesis

• Green chemistry in pharmaceutical manufacturing processes
• Ultrasound assisted reactions: Types of sonochemical reactions, synthetic applications
• Continuous flow reactors: Working principle, advantages and synthetic applications
• Waste minimization and pollution control in formulation industries
• Role of green chemistry in Good Manufacturing Practices (GMP)

Materiovigilance and Hemovigilance

(Theory – BP607T AEC2)

UNIT-1: Introduction to Vigilance Systems

• Overview of Materiovigilance, Hemovigilance and other vigilance system in Healthcare
• Importance of post-marketing surveillance in patient safety
• Scope and objectives of materiovigilance and hemovigilance programs
• Basic concepts of adverse event reporting and safety monitoring
• Historical evolution and global relevance of Materiovigilance, Hemovigilance practices

• Introduction to Materiovigilance Programme of India (MvPI)
• Roles of NCC-MvPI and technical collaborators (e.g., Sree Chitra Tirunal Institute)
• Classification of medical devices (Class A to D) based on risk
• Identification and documentation of Medical Device Adverse Events (MDAEs)
• Medical device reporting forms, process flow, and responsibilities
• Causality assessment of Medical Device Adverse Events

• Overview of Hemovigilance Programme of India (HvPI)
• Organizational structure: NIB, NBTC, hospital-based hemovigilance
• Adverse Transfusion Reactions (ATRs): Types and clinical manifestations
• Use of TRRF (Transfusion Reaction Reporting Form) and HaemoVigil software
• Responsibilities of blood banks, transfusion officers, and healthcare providers
• Case examples along with Causality assessment of Hemolytic reactions, TRALI, TACO, allergic responses.

• International frameworks: US FDA (MAUDE), EU MDR, SHOT (UK), French Hemovigilance
• Comparison of Indian and global materiovigilance/hemovigilance practices
• Signal detection and evaluation of adverse events
• Root cause analysis (RCA) and implementation of corrective & preventive actions (CAPA)
• Risk communication and role of healthcare teams in mitigation

• Demonstration: Reporting of MDAEs and ATRs using mock forms
• Practical exercises in form-filling and event documentation
• Integration of vigilance into hospital quality systems (e.g., NABH, ISO)
• Strategies to enhance adverse event reporting culture
• Ethical considerations and communication with patients/families
• Role of pharmacists, nurses, clinicians, biomedical engineers in vigilance programs

Scientific Writing

(Theory – BP607T AEC3)

UNIT-1: Introduction to Scientific Writing

• Overview of the course
• Principles of scientific writing
• Overview of scientific research
• Introduction to Microsoft tools and its application

• Structure and format of literature reviews
• Conducting a literature review
• Analyzing literature and developing themes
• Writing a compelling introduction
• Developing a clear methodology
• Results and analysis

• Understanding data presentation
• Developing tables and figures
• Using effective graphic design

• Understanding citation styles
• Citation and plagiarism
• Referencing in scientific writing

• Ethical principles in scientific writing
• Misconduct and fraud in scientific writing
• Peer review and publication ethics
• Providing Constructive feedback
• Responding to feedback

Drug Store and Business Management

(Theory – BP607T AEC4)

UNIT-1: Introduction to Trade and Industry

• Objectives and scope of business
• Classification of business activities – industry, commerce, trade
• Forms of business organization: sole proprietorship, partnership, cooperatives, corporations
• Features and merits/demerits of each form Pharmacy business and its legal considerations

• Selection of site, space, and layout of a drug store
• Types of drug stores – hospital pharmacy, community pharmacy, chain pharmacy
• Procurement of drugs and inventory control
• Storage conditions and stock maintenance (cold storage, poisonous drugs, etc.)
• Records and registers to be maintained

• Introduction to inventory control: need and methods
• Economic Order Quantity (EOQ), Reorder Level (ROL), Lead time
• FIFO and LIFO methods
• Sales promotion techniques: advertising, displays, discounts
• Customer relationship management (CRM) in pharmacy

• Basics of accounting: journal, ledger, trial balance
• Introduction to financial statements: profit and loss account, balance sheet
• Pricing policies: markup, markdown, break-even analysis
• Bank transactions: types of accounts, cheques, drafts
• Taxation basics: GST, income tax (as applicable to pharmacies)

• Definition and scope of pharmaceutical marketing
• Elements of marketing mix (4Ps) for pharmacy
• Drug distribution channels: wholesale and retail
• Entrepreneurship development in pharmacy
• Regulatory aspects of retail drug licensing (Drug and Cosmetics Act overview)

Career Building in Cultivation of Medicinal Plants

(Theory – BP607T AEC5)

UNIT-1: Introduction and Industry Overview

• Definition, importance, and cultural background (Ayurveda & ethnobotany)
• Global and Indian demand, healthcare and pharma role
• Key stakeholders: farmers, traders, processors, exporters
• Value chain, supply-demand, government/private initiatives (NMPB, AYUSH, NABARD)

• Botanical characteristics and uses of major plants: Ashwagandha, Tulsi, Aloe vera, Shatavari, Brahmi, etc.
• Regional suitability and agro-climatic zones
• Factors affecting Cultivation: Soil, propagation, irrigation, pest control, organic inputs
• Harvesting, post-harvest management and storage

• Organic certification and sustainable farming practices
• Biodiversity conservation and agroforestry integration
• Processing, drying, packaging, branding
• Market linkages: pharma, cooperatives, online platforms, export guidelines

• Government schemes and legal frameworks (NMPB, AYUSH, forest laws, GACP)
• Entrepreneurship: starting herbal farms, franchises, consulting, contract farming
• Digital tools: farm management software, GIS, mobile apps, ecommerce marketing

• Virtual/shortened farm/nursery visit or guest lecture (can be online)
• Group/individual project: business plan or herbal enterprise pitch presentation

Active Pharmaceutical Ingredients and Excipient Sciences

(Theory – BP607T AEC6)

UNIT-1: Introduction to APIs and Excipients

• Definitions, classifications, and sources (synthetic, natural, biotech APIs; functional excipients).
• Physicochemical properties: Solubility, polymorphism, hygroscopicity, particle characteristics.
• Roles in formulations: Bioavailability enhancement, stability, manufacturability.
• Industry overview: Global market trends, common examples (e.g., paracetamol API, HPMC excipient).

• Excipient selection criteria: Functionality-related characteristics (FRC).
• Compatibility studies: Binary mixtures via DSC, FTIR, XRD.
• Analytical methodologies: HPLC/GC for purity, Karl Fischer titration, laser diffraction for PSD.
• QbD approach: Risk assessment for API-excipient interactions.

• API processes: Synthesis routes, crystallization, drying, milling; labto-pilot scale-up.
• Excipient handling: Sieving, blending, lubrication protocols.
• GMP essentials: Equipment qualification, process validation.
• Unit operations: Wet/dry granulation, direct compression.

• QC tests: Assay, dissolution, content uniformity (IP/USP methods).
• Stability studies: ICH Q1A zones, accelerated/forced degradation.
• Impurity profiling: Genotoxic impurities (ICH M7), residual solvents.
• In-process controls: Blend uniformity, weight variation.

• ICH Q7 guidelines for APIs
• USP-NF excipient monographs and Schedule M requirements
• Drug Master File (DMF) for APIs
• Certificate of Suitability (COS) for excipients
• Process and cleaning validation protocols
• Regulatory inspections (USFDA 483, EMA expectations)
• Emerging trends: green chemistry and bio-based excipients

SKILL ENHANCEMENT COURSE (SEC) PRACTICAL

Computer-Aided Drug Design

(Practical – BP610P SEC1)

General Instruction on Computational Tools
Open-source computational tools are preferred for teaching and learning purposes.
However, institutions may select appropriate software platforms or online resources based on availability, institutional policy, and technical feasibility. The choice of software should enable students to perform the required computational tasks effectively.
The specific software used may vary, but the learning outcomes and computational procedures described below must be achieved using suitable tools.

1. Target Identification and Preparation

• Retrieve protein sequence or structural information from publicly available biological databases.
• Prepare the target protein by removing unwanted molecules, correcting structural issues, and adding necessary atoms or charges using appropriate molecular visualization or preparation tools.
• Identify potential binding or active sites using computational methods that analyze structural pockets and cavities.

1. Ligand Design and Optimization

• Design or sketch candidate molecules using suitable molecular drawing tools.
• Convert structures into three-dimensional form and optimize their geometry using computational chemistry methods.
• Generate multiple conformations of the molecule and perform energy minimization to obtain stable structures.

1. Molecular Docking

• Perform docking simulations using computational docking platforms to predict the interaction between ligands and the target protein.
• Examine binding orientations and molecular interactions using visualization tools.
• Rank compounds based on predicted binding affinity and interaction quality.

1. Pharmacophore Modeling

• Identify essential molecular features responsible for biological activity such as hydrogen bond donors/acceptors, hydrophobic regions, and aromatic centers.
• Construct pharmacophore models representing these key features.
• Use these models to screen compound libraries for molecules that match the required feature pattern.

1. QSAR Modeling

• Calculate molecular descriptors that represent structural and physicochemical properties of compounds.
• Develop predictive statistical or machine learning models that relate these descriptors to biological activity.
• Validate models using appropriate validation techniques such as cross-validation and external datasets.

1. ADMET Prediction

• Evaluate pharmacokinetic and toxicity properties computationally, including:
  o Absorption
  o Distribution
  o Metabolism
  o Excretion
  o Toxicity
• Use predictive computational models and online resources to assess druglikeness and safety profiles.

1. Molecular Dynamics Simulations

• Conduct simulations to study the dynamic behavior of the protein–ligand complex over time.
• Analyze parameters such as structural stability, atomic fluctuations, hydrogen bonding, and interaction persistence.
• Visualize simulation trajectories to understand conformational changes and binding stability.

Analytical Method Development and Validation

(Practical – BP610P SEC2)

(Perform any 12 Experiments)

1. Development of a UV-Visible spectrophotometric method for the assay of paracetamol API. Construction of calibration curve for a model API using UV-Visible spectrophotometry.
2. Determination of solid dosage form by using dissolution method.
3. Analytical method development and validation of Atenolol/metformin by using HPLC.
4. Investigation of different columns for HPLC separation of a Multi-component Drug Mixture.
5. Optimization of mobile Phase composition for HPLC analysis of a selected drug.
6. Optimization of Flow rate and temperature in HPLC for paracetamol/ caffeine.
7. Selection of wavelength for spectrophotometric analysis by HPLC of Marketed drugs.
8. Determination of λmax and calibration curve for qualitative analysis of paracetamol.
9. Determination of effect of pH on Retention time in RP-HPLC.
10. Validation of HPLC method : Determination of LOD and LOQ for paracetamol by HPLC
11. Preliminary Investigation of forced Degradation studies on Ibuprofen by HPLC.
12. Method development for related substances of a drug substance using HPLC.
13. Determination of residual solvent analysis for ethanol/acetone in API by using Gas Chromatography.
14. Development of titrimetric method for the assay of marketed drugs(Ascorbic acid/sodium bicarbonate).

Principles of Preclinical Studies

(Practical – BP610P SEC3)

(Perform any 12 Experiments)

1. Handling, restraining, and sex differentiation of laboratory animals (demo/video)
2. Calculation of dose for animals based on body surface area
3. Routes of administration: oral, intraperitoneal, subcutaneous (simulation)
4. Observation of behavioral effects using actophotometer/rotarod (if available)
5. Determination of acute toxicity (LD50 concept) – case-based calculation
6. Planning a 28-day sub-acute toxicity study protocol
7. Pharmacokinetic study: Cmax, Tmax, AUC calculation (sample dataset)
8. Observation of histopathological slides from toxicity studies
9. Demonstration of sampling methods – blood, urine (case or video)
10. Writing an animal study protocol using CPCSEA format
11. Identification of organs for toxicity evaluation – liver, kidney, brain
12. Visit to CPCSEA-approved animal house/laboratory
13. Observation of animal behavior – grooming, nesting (case-based)
14. Simulated ethics committee approval process (IAEC)
15. Group activity: Design of a preclinical study for a hypothetical drug
    *PCI recommended software’s shall be used for performing experiments.

VALUE ADDED COURSE (VAC) PRACTICAL

Professional Skills

(Practical – BP611P VAC1)

(Perform any 12 Experiments)

1. Self-introduction exercise – verbal and written presentation
2. Resume/CV writing – using current industry formats
3. Mock job interview – panel-based or peer-reviewed
4. Group discussion (GD) – on current healthcare or industry topics
5. Public speaking practice – impromptu and prepared speeches
6. Email etiquette and writing professional emails
7. Time management matrix creation (Eisenhower box)
8. Body language analysis – observe and present feedback
9. Conflict resolution role play – team-based activity
10. Creating a LinkedIn profile and optimizing it professionally
11. Debate session – critical thinking and communication
12. Listening skills test – audio-based task with Q&A
13. Workplace scenario simulation – ethics, teamwork, communication
14. Presentation skills – create and deliver PowerPoint presentations
15. Goal-setting and career mapping – using SMART goals

Process Analytical Technology (PAT) and QbD in Formulation Science

(Practical – BP611P VAC2)

1. Identify Critical Quality Attributes (CQAs) – Brainstorm and list five tablet CQAs (hardness, dissolution, etc.) and link each to patient safety or efficacy.
2. Ishikawa (Fish-Bone) Diagram – Draw a cause-and-effect diagram for poor tablet dissolution, categorising factors into Materials, Methods, Machines and Manpower.
3. Blend-Uniformity by NIR Probe – Collect in-line near-infrared spectra during 10 min of blender operation and plot real-time API concentration trends.
4. Moisture Tracking with NIR – Use a portable NIR gun to measure LOD in wet granules every 2 min, stopping when the plot hits the 3 % target.
5. Mini DoE for Granulation – Run a 2² design varying impeller speed and granulation time; measure granule mean size and create main-effects plots.
6. Real-Time Release Test (RTRT) – Set up an at-line NIR hardness prediction model, test 20 tablets, and compare predicted vs. actual hardness.
7. Control Chart of Particle Size (FBRM) – Stream Focused Beam Reflectance data during milling; plot X̄ and R for d₅₀ and decide if the process is in control.
8. Multivariate Calibration Model – Build a partial-least-squares (PLS) model correlating NIR spectra to drug content; report R² and RMSEP.
9. FMEA Risk-Priority Number – Score severity, occurrence and detectability for three high-risk process variables; rank them by RPN and suggest mitigation.
10. PAT Model Verification Batch – Run the optimised process, capture PAT data, and confirm that all CQAs meet specification without end-product testing.