Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Jul 2010
Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.
European legislation for medicines places the emphasis on an assessment of quality, safety and efficacy during the procedure for the granting of marketing authorisations for medicines, in order to protect patient health. The integrated European regulatory system involves the participation of a network of experts from the agencies of the member states that takes part in the European procedures for the authorisation of medicines. On the way to full membership in the EU, candidate countries and potential candidates have to transpose and implement the European directives for medicinal products; they must also strengthen their scientific and administrative capacities. ⋯ However, there are still some provisions to transpose before actual full membership, and also dossier upgrading, in which the marketing authorisation holder has to harmonise its documentation about a medicinal product with the requirements of the directives, if a product already on the market was not previously approved in line with current European legislation. Collaboration with the European Medicines Agency (EMA) through an Instrument for Pre-Accession (IPA) provides candidate countries and potential candidates the opportunity for education and training in some regulatory activities as well as the participation of their representatives as observers in some EMA committees and working groups. Some characteristics of the national regulatory frameworks of the countries of South East Europe in their efforts to achieve harmonisation with EU legislation are presented in this paper.
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Regul. Toxicol. Pharmacol. · Apr 2010
Derivation of a toxicity reference value for nitrogen trichloride as a disinfection by-product.
Nitrogen trichloride is a highly volatile chlorination disinfection by-product, very commonly found in the air of indoor swimming pools. The aim of this work is to characterize the hazard associated with it and to determine the concentration at which health effects appear, for application in health risk assessments for users of indoor swimming pools. Hazard identification was based on a literature survey and analysis of animal and human studies, with special attention paid to their methodological quality and to reports of a dose-response relationship. ⋯ Two uncertainty factors were applied to take into account both intra-species variability and the use of a concentration with an effect rather than a no-observed-adverse-effect-level. A toxicity reference value of 4x10(-3)mg/m(3) for nitrogen trichloride is proposed for repeated short exposures. Alternative values based on animal data range from 0.01 to 0.03mg/m(3).
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Regul. Toxicol. Pharmacol. · Feb 2010
Comparative StudyEstimating tar and nicotine exposure: human smoking versus machine generated smoke yields.
Determine human smoked (HS) cigarette yields of tar and nicotine for smokers using their own brand in their everyday environment. ⋯ A significant difference (p<0.0001) in HS yields of tar and nicotine between tar bands was found. Machine-smoked yields were reasonable predictors of the HS yields for groups of subjects, but the relationship was neither exact nor linear. Neither the FTC, the Massachusetts (MA) nor the Canadian Intensive (CI) machine-smoking methods accurately reflect the HS yields across all brands. The FTC method was closest for the 7-12 mg and 13+ mg products and the MA method was closest for the 1-3mg products. The HS yields for the 4-6 mg products were approximately midway between the FTC and the MA yields. HS nicotine yields corresponded well with published urinary and plasma nicotine biomarker studies.
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Regul. Toxicol. Pharmacol. · Nov 2009
ReviewComments on serious anaphylaxis caused by nine Chinese herbal injections used to treat common colds and upper respiratory tract infections.
Reports describing severe allergic shock and fatality following treatment of a common cold or upper respiratory tract infection (URTI) with a Chinese herbal injection were collected. Our analysis of the risks associated with this treatment suggested that the potential risk of serious, or even lethal, anaphylaxis should preclude its use in treating common colds and URTIs. In light of our findings herein, we propose the following five suggestions for improving the clinical safety of delivering Chinese herbal injections as medical treatments. ⋯ Third, Chinese herbal injections should be used only in cases involving severe disease or to rescue patients in critical condition; they should not be used to treat mild, relatively innocuous diseases, such as common colds and upper respiratory tract infections, given the risk of doing harm. Fourth, Chinese herbal injection formulas should include materials from only a single or a small number of plant sources in known quantities. Fifth, more studies examining the toxicology and allergenic potential of Chinese herbal injections are needed.
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Regul. Toxicol. Pharmacol. · Nov 2009
Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
There are clear minimum requirements for non-clinical (toxicology) studies which are needed prior to human exposure to a potential new pharmaceutical and additional studies are needed in an ongoing manner to support clinical development and marketing [ICH, 2009. ICH M3(R2) Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95). Adopted June 2009, effective December 2009.] The pharmaceutical industry is under increasing pressure to reduce costs and reduce, refine and replace the use of animals, as far as possible. ⋯ Conclusion. Some increases in non-clinical PMCs were attributed to increased non-clinical data requirements from the Regulators. However, strategic deferrals by the Applicant, unintended omissions due to poor regulatory intelligence and overall differences in risk perception between Regulators and Applicants account for a significant proportion of the non-clinical PMCs.