BP607T AEC2

Materiovigilance and Hemovigilance (Theory)

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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.

UNIT 2

Metabolomics and Systems Biology 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

UNIT 3

Modern Techniques in Natural Product 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. .

UNIT 4

Validation and Development of Herbal Leads 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.

UNIT 5

Patenting of Natural Products 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.