BP801TSemester 82 creditsTheoryKEY SUBJECT
Ethical Considerations and Translational Applications of AI in Pharmacy
Complete unit-wise syllabus for BP801T as per the PCI B.Pharm NEP 2020 curriculum (Semester 8 — AI Ethics + Clinical + Final Research).
URL:
https://pharmacode.vercel.app/syllabus/semester-8/bp801t-ethical-considerations-and-translational-applications-of-ai-in-pharmacy/Unit-wise Syllabus
5 Units1
AI Ethics and System Lifecycle in Healthcare6 Hours- Overview of AI system lifecycle in pharmacy: data collection, preprocessing, modelling, validation, deployment, monitoring, and decommissioning
- AI ethics fundamentals: algorithmic bias (sources, types, consequences); fairness metrics (demographic parity, equalized odds); transparency and accountability in healthcare AI
- Data privacy in AI: DPDPA (India), GDPR (EU), HIPAA (USA) — implications for health data used in AI; federated learning as a privacy-preserving approach
2
Regulatory Frameworks for AI Medical Devices6 Hours- FDA guidance on AI/ML-based Software as a Medical Device (SaMD): risk classification; predetermined change control plan (PCCP); total product lifecycle (TPLC) approach
- EMA reflection paper on AI in medicine; CDSCO emerging guidance on AI-based medical devices; ISO 13485 and IEC 62304 for AI software in medical devices
- Explainable AI (XAI): concept, need for explainability in clinical decisions; LIME, SHAP explainability methods; interpretability vs. accuracy trade-off
3
AI in Pharmacy Automation and Supply Chain6 Hours- Overview of AI in automated dispensing systems: robotic dispensing, automated storage and retrieval; medication error reduction through AI
- AI in pharmaceutical supply chain: inventory prediction models, demand forecasting (ML-based), cold chain monitoring, counterfeit detection using computer vision
- Pharmacovigilance AI: AI-enhanced ADR detection from EHR data, social media, and spontaneous reports; NLP for case narrative processing; signal detection automation
4
AI in Public Health and Precision Medicine6 Hours- AI in public health: real-world data sources (EHR, insurance claims, surveillance systems); pharmacoepidemiology with ML; epidemic forecasting (COVID-19 AI applications)
- AI in pharmacogenomics and precision medicine: genotype-guided dosing; polygenic risk scores; AI integration with omics data (genomics, proteomics, metabolomics); digital biomarkers
- Students implement a supervised ML model (regression, logistic regression, or classification) using real-world pharmacy data from domains: formulation, PK, ADR detection, or drug repurposing
5
Translational AI and Future Perspectives6 Hours- Translational AI: bench to bedside; challenges in translating AI research to clinical practice; real-world evidence validation; post-deployment monitoring of AI models
- Future of AI in pharmacy: autonomous AI for drug discovery (AlphaFold protein structure prediction); generative AI in molecule design; challenges of AI adoption in Indian pharma
- Professional competencies for AI-aware pharmacists: data literacy, critical appraisal of AI tools, ethical reasoning; continuing education requirements for clinical AI
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- Reference textbooks and recommended reading list
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- Topic-wise short notes and revision summaries
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Other subjects in Semester 8
BP802TClinical PharmacotherapeuticsBP803TIndustrial Pharmacy and Facility DesignBP804TPharmaceutical ManagementBP805TSterile Dosage Forms and Novel Drug Delivery SystemBP806T AECAEC Elective (Pharma Packaging / Supply Chain / Industrial Safety / Traditional Healing / AR-VR Pharma 4.0 / Herbal Cosmetics)BP807P + BP808PPracticals — Pharmaceutical Marketing Skills + Sterile Dosage Forms + VAC ElectiveBP810RPResearch Project (Final Submission)