Herbal Drug Evaluation, Patents & Regulations Notes [U-4]
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Evaluation of Drugs
- WHO Guidelines for the Assessment of Herbal Drugs
- ICH Guidelines for the Assessment of Herbal Drugs
- Stability Testing of Herbal Drugs
Patenting and Regulatory requirements of natural products
- Patent
- Intellectual Property Rights (IPR)
- Farmers’ Rights
- Breeder’s Rights
- Bioprospecting
- Biopiracy
- Patenting Aspects of Traditional Knowledge and Natural Products
- Case Study of Curcuma (Turmeric)
- Case Study of Neem
Regulatory issues
- ASU Drugs Technical Advisory Board (ASU-DTAB)
- ASU Drugs Consultative Committee (ASU-DCC)
- Regulation of ASU Drug Manufacture in India
- Schedule Z of the Drugs & Cosmetics Act for ASU Drugs
Other Units of Herbal Drug Technology
Herbal Drug Technology
Other Subjects of B Pharmacy 6th Semester
Topic wise notes of:
Medicinal Chemistry III
- Antibiotics & Aminoglycosides
- Antibiotics & Antimalarials: Structures & SAR
- Anti-TB, UTI & Antiviral Agents
- Antifungals, Antiprotozoals & Sulfonamides
- Intro to Drug Design & QSAR Approaches
Topic wise notes of:
Biopharmaceutics and Pharmacokinetics
- Biopharmaceutics: Absorption & Distribution
- Drug Elimination, Bioavailability & Bioequivalence
- Pharmacokinetics Models, Dosing & Parameters
- Multicompartment models
- Nonlinear Pharmacokinetics
Topic wise notes of:
Pharmacology III
- Respiratory & GI Tract Drug Pharmacology
- Chemotherapy: Principles & Key Antibiotics
- Chemotherapy: TB, Fungal & Parasitic Drugs
- UTIs, Cancer Chemo & Immunopharmacology
- Toxicology Basics & Chrono pharmacology
Topic wise notes of:
Pharmaceutical Biotechnology
- Introduction to Pharmaceutical Biotechnology
- Genetic Engineering & rDNA Technology
- Immunology and Vaccine Technology
- Microbial Genetics & Biotransformation
- Fermentation & Bioproduct Production
Topic wise notes of:
Pharmaceutical Quality Assurance
- Quality Assurance, GMP, ICH, QbD & Quality System
- GMP: Personnel, Premises & Equipment Control
- Quality Control and Good Laboratory Practice
- Complaints & Document Management
- Calibration and Warehousing
Unit-IV: Evaluation and Regulation of Herbal Drug Notes Summary
This unit focuses on the quality evaluation, regulatory standards, and patenting aspects of herbal and natural products.
Key Highlights:
- Evaluation Guidelines: Overview of WHO and ICH guidelines for quality assessment and stability testing of herbal drugs.
- Patents and IPR:
- Definitions of Patent, Intellectual Property Rights (IPR), Farmers’ Right, Breeders’ Right, Bioprospecting, and Biopiracy.
- Patenting of Traditional Knowledge and Natural Products with case studies on Curcuma (Turmeric) and Neem.
- Regulatory Framework:
This unit ensures awareness of global and national standards in herbal drug development, protecting traditional knowledge, and promoting safe herbal medicine use
At FirstHope, we provide BPharm notes that are topic-wise, easy to understand, and designed strictly as per the AKTU and Other Universities, hence designed according to PCI syllabus.
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