Subject Details
Dept     : B.Pharm
Sem      : 8
Regul    : 2017
Faculty : staff009
phone  : NIL
E-mail  : pradeepa.d@snscphs.org
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Syllabus

UNIT
1
Basic tests for drugs

Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage forms WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude drugs intended for use

UNIT
2
Quality assurance in herbal drug industry

Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in traditional system of medicine. WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines WHO Guidelines on GACP for Medicinal Plants.

UNIT
3
Research Guidelines

EU and ICH guidelines for quality control of herbal drugs. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

UNIT
4
Standardization of herbal products.

Stability testing of herbal medicines.Application of various chromatographic techniques in standardization of herbal products. Preparation of documents for new drug application and export registration GMP requirements and Drugs & Cosmetics Act provisions

UNIT
5
Pharmacovigilance systems

Regulatory requirements for herbal medicines. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems Comparison of various Herbal Pharmacopoeias. Role of chemical and biological markers in standardization of herbal products

Reference Book:

1. Pharmacognosy by Trease and Evans 2. Pharmacognosy by Kokate, Purohit and Gokhale 3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006. 4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.

Text Book:

1. Pharmacognosy by Trease and Evans 2. Pharmacognosy by Kokate, Purohit and Gokhale 3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006. 4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.

 

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