Designing toxicological evaluation of ayurveda and siddha products to cater to global compliance - current practical and regulatory perspectives

Journal of Pharmaceutical Sciences and Research

Volumn 2, Issue 12, 2010, Pages 867-877

  Chandramouli, R ^a   Thirunarayanan, T ^b   Mukeshbabu, K ^a   Sriram, R ^a  

^a SASTRA UNIVERSITY   (India)

^b Centre for Traditional Medicine and Research   (India)

Author keywords

Ayurvedic products; Global compliance; OECD guidelines; Toxicological testing

Indexed keywords

ALKALOID; AYURVEDIC DRUG; CARBOHYDRATE; FLAVONOID; GLYCOSIDE; HERBACEOUS AGENT; POLYPHENOL DERIVATIVE; QUININE DERIVATIVE; TANNIN DERIVATIVE;

ACUTE TOXICITY; ARTICLE; AUTOPSY; BODY WEIGHT; CARCINOGENICITY; CHRONIC TOXICITY; DOSE RESPONSE; DRUG SAFETY; EXPERIMENTAL ANIMAL; FLUID INTAKE; FOOD INTAKE; GENOTOXICITY; HISTOPATHOLOGY; IMMUNOTOXICITY; LD 50; NEUROTOXICITY; NONHUMAN; ORGAN WEIGHT; REPRODUCTIVE TOXICITY; TOXICITY TESTING;

EID: 79251512301     PISSN: None     EISSN: 09751459     Source Type: Journal    
DOI: None     Document Type: Article

References (35)

1. Zhu M, Lew KT, Leung P (2002). Protective effects of plant formula on ethanol-induced gastric lesions in rats. Phytother Res 16: 276-280.
2. USFDA (2006). Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Draft guidance U.S. Department of Health and Human Services Food and Drug Administration.
3. Barnes J, (2003). Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf. 2003;26(12):829-851.
4. MHRA (2005). Latest documents for the Committee on Safety of Medicines. Available from: http://www.mhra.gov.uk/Committees/Medicinesadvisorybodies/HerbalMedicinesAdvisoryCommittee/CON2023436
5. Vora CK, Mansoor GA (2005). Herbs and alternative therapies: relevance to hypertension and cardiovascular diseases. Curr Hypertension Rep 7: 275-280.
6. Schoepfer AM, Engel A, Fattinger K et al. (2007). Herbal does not mean innocuous: Ten cases of severe hepatotoxicity associated with dietary supplements from Herbalife (R) products. J Hepatol 47 (4): 521-526.
7. Kean, W.F., Hart, L., and Buchanan, W.W., Auranofin, Brit. J. Rheumatol., 82, 560, 1997.
8. Rao, S.K.R., Encyclopedia of Indian Medicine: Historical Perspective, Popular Prakashan, Bombay, India, 1985.
9. Sharma, D.C., India raises standards for traditional drugs, Lancet, 356, 231, 2000
10. Chopra, A. and Doiphode, V.V., Ayurvedic medicine: core concept, therapeutic principles, and relevance, Med. Clin. North Am., 86, 75, 2002.
11. Raghunathan, K., Pharmacopoeial Standards for Ayurvedic Formulations, Central Council for Research in Indian Medicine Homeopathy (CCRIMH), Publ. 15, New Delhi, India, 1976.
12. Sharma, D.C., Jha, J., Sharma, P., and Gaur, B.L., Evaluation of safety and efficacy of a gold containing Ayurvedic drug, Indian J. Exp. Biol., 39, 892, 2001
13. Tripathi, Y.B. and Singh, V.P., Role of tamra bhasma an Ayurvedic preparation, in the management of lipid peroxidation in liver of albino rats, Indian J. Exp. Biol., 34, 66, 1996
14. Pandit, S., Biswas, T.K., Debnath, P.K., Saha, A.V., Chowdhury, U., Shaw, B.P., Sen, S., andMukherjee, B., Chemical and pharmacological evaluation of different Ayurvedic preparations of iron, J. Ethnopharmacol., 65, 149, 1999
15. Kanase, A., Patil, S., and Thorat, B., Curative effect of mandur bhasma on liver and kidney of albino rats after induction of acute hepatitis by CCl4, Indian J. Exp. Biol., 35, 754, 1997.
16. Chauhan, O., Godhwani, J.L., Khanna, N.K., and Pendse, V.K., Antiinflammatory activity of muktashukti bhasma, Indian J. Exp. Biol., 36, 985, 1998.
17. Puri, R.N., Thakur, V., and Nema, H.V., Role of zinc (yashad bhasma) in arrest of myopia, Indian J. Ophthalmol., 31 (Suppl.) 816, 1983.
18. OECD Principles of Good Laboratory Practice (as revised in 1997). OECD Environmental Health and Safety Publications (OECD) 1. 1998
19. New tables for multiple comparisons with a control. Biometrics, Vol. 20, No. 3 (Sep.,), pp. 482-491
20. Abdi, H (2007). Bonferroni and Šidák corrections for multiple comparisons. in N.J. Salkind (ed.). Encyclopedia of Measurement and Statistics. Thousand Oaks, CA: Sage available online Abdi, H (2007). Bonferroni and Šidák corrections for multiple comparisons. in N.J. Salkind (ed.). Encyclopedia of Measurement and Statistics. Thousand Oaks, CA: Sage
21. Miller LC, Tainter ML (1944). Estimation of ED50 and its error by means of log-probit graph paper. Proc Soc Exp Biol Med 57: 261-269.
22. Litchfield JT, Wilcoxon FJ (1949). A simplified method of evaluating dose-effect experiments. J Pharmacol Exp Ther 96: 99-113.
23. Lorke D (1983). A new approach to practical acute toxicity testing. Arch Toxicol 54: 275-287.
24. OECD (2001). Test Guideline 420. Acute oral toxicity - fixed dose procedure (FDP). In: OECD Guidelines for the Testing of Chemicals. Organisation for Economic Cooperation and Development, Paris
25. OECD (2001). Test Guideline 423. Acute Oral Toxicity - Acute Toxic Class Method. In: OECD Guidelines for the Testing of Chemicals. Organisation for Economic Cooperation and Development, Paris.
26. OECD (2006). Test Guideline 425. Acute Oral Toxicity - Up and Down Procedure (UDP. In: OECD Guidelines for the Testing of Chemicals. Organisation for Economic Cooperation and Development, Paris.
27. OECD (1995). Test Guideline 407. Repeated Dose 28-day Oral Toxicity Study in Rodents. In: OECD Guidelines for the Testing of Chemicals. Organisation for Economic Cooperation and Development, Paris
28. OECD (1998). Test Guideline 408. Repeated Dose 90-day Oral Toxicity Study in Non-rodents. In: OECD Guidelines for the Testing of Chemicals. Organisation for Economic Cooperation & Development, Paris
29. Bush BM (1991). Interpretation of Laboratory Results for Small Animal Clinicians. Blackwell Scientific Publications, London.
30. WHO (1990). Principles for the Toxicological Assessment of Pesticide Residues in Food, Environmental Health Criteria 104. IPCS/WHO, Geneva.
31. Paynter OE (1984). Oncogenic Potential: Guidance for Analysis and Evaluation of Long Term Rodent Studies. Evaluation Procedure #1000.1. Office of Pesticide and Toxic Substances, EPA, Washington, D.C.
32. Korach KS (Ed) (1998). Reproductive and Developmental Toxicology. Marcel Dekker, New York.
33. OECD (1983). Test Guideline 415. One-Generation Reproduction Toxicity Study. In: OECD Guidelines for the Testing of Chemicals. Organisation for Economic Cooperation and Development, Paris.
34. OECD (2001). Test Guideline 416.Two-Generation Reproduction Toxicity Study. In: OECD Guidelines for the Testing of Chemicals. Organisation for Economic Cooperation and Development, Paris
35. OECD (1982). Good Laboratory Practice in the Testing of Chemicals. Organisation for Economic Cooperation and Development, Paris, p. 62.