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Source: Regulatory Toxicology and Pharmacology : RTP

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Total 3 results found since Jan 2013.

Safety and compliance of a complex homeopathic drug (Contramutan N Saft) in the treatment of acute respiratory tract infections: a large observational (non-interventional) study in children and adults focussing on homeopathy specific adverse reactions versus adverse drug reactions.
CONCLUSIONS: The homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity. PMID: 25882307 [PubMed - as supplied by publisher]
Source: Regulatory Toxicology and Pharmacology : RTP - April 13, 2015 Category: Toxicology Authors: Michalsen A, Uehleke B, Stange R Tags: Regul Toxicol Pharmacol Source Type: research

Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.
In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products. PMID: 24384395 [PubMed - as supplied by publisher]
Source: Regulatory Toxicology and Pharmacology : RTP - December 30, 2013 Category: Toxicology Authors: Buchholzer ML, Werner C, Knoess W Tags: Regul Toxicol Pharmacol Source Type: research

Feasibility study of nonclinical safety assessments on homeopathic preparations using the example of protoanemonin in Pulsatilla pratensis L.
Abstract Homeopathy is a world-wide available form of complementary therapy, which has a tradition of 200years. Due to the long history of clinical use, i.e. reflected by the first edition of the Homeopathic Pharmacopoeia of the US of 1914, the conduct of toxicological studies is not required if the safety has been otherwise substantiated. The aim of this article is to establish a risk assessment procedure without full toxicological examination, using homeopathic preparations from Pulsatilla pratensis L. as an example. The literature review shows that protoanemonin is the most relevant constituent of these plants ...
Source: Regulatory Toxicology and Pharmacology : RTP - May 22, 2013 Category: Toxicology Authors: Schrenk D, Merz KH, Jochims K Tags: Regul Toxicol Pharmacol Source Type: research