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GMP for Botanicals: Regulatory and Quality Issues on Phytomedicines / Verpoorte, Robert & Mukherjee, Pulok K. (Eds.)
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GMP for Botanicals: Regulatory and Quality Issues on Phytomedicines
Verpoorte, Robert & Mukherjee, Pulok K. (Eds.)
 
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  Book ID : 25146
  ISBN-10 : 81-900788-5-2 / 8190078852
  ISBN-13 : 978-81-900788-5-6 / 9788190078856
  Place of Publication : Delhi
  Year of Publication : 2010
  Edition : (Second Reprint)
  Language : English
  x, 388p., Figs., Tables, Index, 25 cm. (First Edition pub. in 2003)
   
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 CONTENTS
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CONTENTS:-
1. Development of natural products/Robert Verpoorte;
2. Exploring regulations on GMP for herbal medicines/Willem K. Scholten;
3. Overview of global regulatory status/KK. Bhutani, HR Jadhav;
4. Regulatory control on phytomedicines/VB Desai, Shrishailappa Badami, Giriraj T. Kulkarni and B. Suresh;
5. Regulations governing herbal medicines production in Russia/VA Severtsev, VG Makarov, AN Shikov, ON Pozharitskaya;
6. GMP and quality control of phytomedicines/Rajeev K. Sharma;
7. GMP for Indian systems of medicine/Pulok K. Mukherjee;
8. GMP for production of phytomedicines/J.P.S. Kohli;
9. Ayurveda and GMP/KS Jayashree;
10. Quest for GMP in the production of quality botanicals/Pulok K. Mukherjee and BP Saha;
11. Development of Ayurvedic medicine/DS Lucas;
12. Manufacturing and quality control of Ayurvedic and herbal preparations/J. Singh, GD Bagchi and SPS Khanuja;
13. Ensuring safe use of herbal drugs/M.K. Chattopadhyay;
14. Quality and safety of botanicals/K. Sadasivan Pillai and V. Amalan Stanley;
15. Analysis of South Pacific herbal drugs/Subramaniam Sotheeswaran;
16. Quality control of botanicals containing essential oils/A. Zaenglein;
17. Mass spectrometry applications in herbal medicine analysis/Pierluigi Mauri and Piergiorgio Pietta;
18. Capillary electrophoresis in herbal medicine analysis/Piergiorgio Pietta and Claudio Gardana;
19. Pharmacological evaluation in Herbal drug development/A. Subramoniam;
20. Clinical trials of herbal medicines/Carmen Tamayo;
21. Role of bioassays in development of natural products/Amit Agarwal and Prasanth D Souza.
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 DESCRIPTION
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The concept of Good Manufacturing Practices (GMP) is well known to the pharmaceutical industry of the world, which finds expressions in many countries in regulations, codes and guides. In the era of revolution in herbal medicines throughout the world, the need of the day is the implementation of GMP in the production of botanicals, including the production of medicinal products from natural resources. Besides the widespread use of phytomedicines in developing countries for their historical and cultural reasons, concurrently alternative and complimentary medicine has been included in the developed countries too for their potential therapeutic efficacy. Thus the plant drugs are used throughout the world as home remedies, over-the counter drug products and also as raw materials for the pharmaceutical industries and thereby represent a substantial proportion of the global medicines market. To combat the worldwide demand of the herbal medicines, the maintenance of GMP is by. This is required right from the cultivation of herbal drugs in the field to the preparation of its different formulations either with the crude power or with the extract or with some purified components made there from. Thus strict control on each and every step of the different aspects of herbal medicines production like cultivation, collection, storage, extraction, formulation, processing, standardization, quality control and packaging etc. have to be taken for the development of herbal drugs of uniform quality. Proper documentation of each and every step from the cultivation to formulations including specification of all the stages involved therein today has global importance. To retain the quality in a phyto-pharmaceutical, it must be ensured that the co-existing materials are also taken care of instead of carrying out a quantitative extraction of what might generally be considered to be the active constituents.
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