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A 1:
For evaluation of Safety Assessment of Herbal Extract, selection of appropriate guideline will depend on following :
•Whether the information on ingredients/plant is available in Authentic books of Ayurveda, Unani, Siddha or not?
•Whether the constituents of extract are well characterized, purified and standardized with defined minimum bio-active or phyto-chemical compounds or not
•Country in which clinical trials to be conducted In India, for all formulations containing only such ingredients which are mentioned in the formulae described in the authoritative books of Ayurveda, Siddha and Unani Tibb system of medicine: AYUSH route of filing to be followed and relevant guidelines are " GENERAL GUIDELINES FOR SAFETY/TOXICITY EVALUATION OF AYURVEDIC FORMULATIONS" from CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES, Ministry of AYUSH, Govt, of India New Delhi. Web Link is http://www.ccras.nic.in/sites/default/files/viewpdf/Publication/CCRAS_Guideline%20of%20Safety_Toxicity.pdf. For Phytopharmaceuticals, i.e. purified and standardized fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals, the appropriate guidelines are “ Drug and Cosmetic Act” through DCGI route. Web Link is : https://upload.indiacode.nic.in/showfile?actid=AC_CEN_12_13_00023_194023_1523353460112&type=rule&filename=Drugs%20and%20Cosmetics%20Act,%201940%20and%20Rules,%201945.pdf Both the above mentioned guidelines are applicable for India filing . For filing in US the guideline to be followed is " Botanical Drug Development- Guidance for Industry" U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), December 2016, Pharmaceutical Quality/CMC, Revision 1. Web Link is https://www.fda.gov/media/93113/download
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A1: Sparse sampling: blood sample will be collecting at different time points from the specified animals. Continuous sampling: blood sample will be collecting from all the animals from all time points.
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Right eye will be selected for test item instillation and left eye will act as control
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