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Bourgeois A.L.,French Institute of Health and Medical Research | Auriche P.,Agence nationale de securite du medicament et des produits de sante ANSM | Palmaro A.,French Institute of Health and Medical Research | Montastruc J.L.,French Institute of Health and Medical Research | Bagheri H.,French Institute of Health and Medical Research
Annales d'Endocrinologie | Year: 2016

Objective: After the diagnosis of transsexualism, hormone therapy is an established stage of gender identity disorder treatment for inducing secondary sex characteristic development of the target gender while reducing that of the birth sex. The aim of this study was to review existing data about the risk of hormone therapy in transsexual people. Methods: A PubMed search was done to identify relevant data about adverse drug reactions (ADRs) and mortality associated to hormones exposure. Furthermore, case reports of hormonal therapy-induced ADRs were identified in the French Pharmacovigilance DataBase (FPDB). Results: Review of currently available data showed an increase of thromboembolic effects and hyperprolactinemia with oestrogens. Both oestrogens and testosterone derivatives could induce hepatic effects. Currently, there is no significant association between hormone exposure and cancer or mortality in transsexual people. Five ADRs were found in FPDB, and two of them were related to misuse (voluntary overdose and prescription error). Conclusion: Potential for under-reporting and under-identification in the FPDB of hormonal therapy-induced ADRs in transsexual people should be underlined. Technical improvement of the FPDB could facilitate further identification of reports concerning the risk associated with hormonal therapy in transsexual subjects. © 2015 Elsevier Masson SAS.


Morgeaux S.,Agence nationale de securite du medicament et des produits de sante ANSM | Variot P.,Agence nationale de securite du medicament et des produits de sante ANSM | Daas A.,A+ Network | Costanzo A.,A+ Network
Pharmeuropa bio & scientific notes | Year: 2013

The goal of the project was to standardise a new in vitro method in replacement of the existing standard method for the determination of hepatitis A virus antigen content in hepatitis A vaccines (HAV) marketed in Europe. This became necessary due to issues with the method used previously, requiring the use of commercial test kits. The selected candidate method, not based on commercial kits, had already been used for many years by an Official Medicines Control Laboratory (OMCL) for routine testing and batch release of HAV. After a pre-qualification phase (Phase 1) that showed the suitability of the commercially available critical ELISA reagents for the determination of antigen content in marketed HAV present on the European market, an international collaborative study (Phase 2) was carried out in order to fully validate the method. Eleven laboratories took part in the collaborative study. They performed assays with the candidate standard method and, in parallel, for comparison purposes, with their own in-house validated methods where these were available. The study demonstrated that the new assay provides a more reliable and reproducible method when compared to the existing standard method. A good correlation of the candidate standard method with the in vivo immunogenicity assay in mice was shown previously for both potent and sub-potent (stressed) vaccines. Thus, the new standard method validated during the collaborative study may be implemented readily by manufacturers and OMCLs for routine batch release but also for in-process control or consistency testing. The new method was approved in October 2012 by Group of Experts 15 of the European Pharmacopoeia (Ph. Eur.) as the standard method for in vitro potency testing of HAV. The relevant texts will be revised accordingly. Critical reagents such as coating reagent and detection antibodies have been adopted by the Ph. Eur. Commission and are available from the EDQM as Ph. Eur. Biological Reference Reagents (BRRs).


Andre M.,Agence nationale de securite du medicament et des produits de sante ANSM | Reghin S.,Agence nationale de securite du medicament et des produits de sante ANSM | Boussard E.,Agence nationale de securite du medicament et des produits de sante ANSM | Lempereur L.,Agence nationale de securite du medicament et des produits de sante ANSM | Maisonneuve S.,Agence nationale de securite du medicament et des produits de sante ANSM
Biologicals | Year: 2016

Residual host cellular DNA (rcDNA) is one of the principal risk associated with continuous cell lines derived medicines such as viral vaccines. To assess rcDNA degradation, we suggest two quantitative real-time PCR assays designed to separately quantify target sequences shorter and longer than the 200 bp risk limit, the relative abundance of both targets reflecting the extent of rcDNA fragmentation. The conserved multicopy ribosomal 18S RNA gene was targeted to detect host cell templates from most mammalian cell substrates commonly used in the manufacture of human viral vaccines. The detection range of the method was assessed on purified DNA templates from different animal origins. The standard calibrator origin and structural conformation were shown crucial to achieve accurate quantification. Artificial mixtures of PCR products shorter and longer than 200 bp were used as a model to check the ability of the assay to estimate the fragment size distribution. The method was successfully applied to a panel of Vero cell derived vaccines and could be used as a universal method for determination of both content and size distribution of rcDNA in vaccines. © 2016 International Alliance for Biological Standardization.


Gimeno P.,Agence nationale de securite du medicament et des produits de sante ANSM | Maggio A.-F.,Agence nationale de securite du medicament et des produits de sante ANSM | Bousquet C.,Agence nationale de securite du medicament et des produits de sante ANSM | Quoirez A.,Agence nationale de securite du medicament et des produits de sante ANSM | And 2 more authors.
Journal of Chromatography A | Year: 2012

Esters of phthalic acid, more commonly named phthalates, may be present in cosmetic products as ingredients or contaminants. Their presence as contaminant can be due to the manufacturing process, to raw materials used or to the migration of phthalates from packaging when plastic (polyvinyl chloride - PVC) is used. 8 phthalates (DBP, DEHP, BBP, DMEP, DnPP, DiPP, DPP, and DiBP), classified H360 or H361, are forbidden in cosmetics according to the European regulation on cosmetics 1223/2009. A GC/MS method was developed for the assay of 12 phthalates in cosmetics, including the 8 phthalates regulated. Analyses are carried out on a GC/MS system with electron impact ionization mode (EI). The separation of phthalates is obtained on a cross-linked 5%-phenyl/95%-dimethylpolysiloxane capillary column 30m×0.25mm (i.d.)×0.25mm film thickness using a temperature gradient. Phthalate quantification is performed by external calibration using an internal standard. Validation elements obtained on standard solutions, highlight a satisfactory system conformity (resolution>1.5), a common quantification limit at 0.25ng injected, an acceptable linearity between 0.5μgmL -1 and 5.0μgmL -1 as well as a precision and an accuracy in agreement with in-house specifications. Cosmetic samples ready for analytical injection are analyzed after a dilution in ethanol whereas more complex cosmetic matrices, like milks and creams, are assayed after a liquid/liquid extraction using ter-butyl methyl ether (TBME). Depending on the type of cosmetics analyzed, the common limits of quantification for the 12 phthalates were set at 0.5 or 2.5μgg -1. All samples were assayed using the analytical approach described in the ISO 12787 international standard " Cosmetics-Analytical methods-Validation criteria for analytical results using chromatographic techniques" This analytical protocol is particularly adapted when it is not possible to make reconstituted sample matrices. © 2012 Elsevier B.V.


Gimeno P.,Agence nationale de securite du medicament et des produits de sante ANSM | Maggio A.-F.,Agence nationale de securite du medicament et des produits de sante ANSM | Bancilhon M.,Agence nationale de securite du medicament et des produits de sante ANSM | Lassu N.,Agence nationale de securite du medicament et des produits de sante ANSM | And 3 more authors.
Journal of Chromatographic Science | Year: 2016

Corticosteroids, hydroquinone and its ethers are regulated in cosmetics by the Regulation 1223/2009. As corticosteroids are forbidden to be used in cosmetics and cannot be present as contaminants or impurities, an identification of one of these illicit compounds deliberately introduced in these types of cosmetics is enough for market survey control. In order to quickly identify skin-whitening agents present in illegal cosmetics, this article proposes an HPLC-UV method for the identification and screening of hydroquinone, 3 ethers of hydroquinone and 39 corticosteroids that may be found in skin-whitening products. Two elution gradients were developed to separate all compounds. The main solvent gradient (A) allows the separation of 39 compounds among the 43 compounds considered in 50 min. Limits of detection on skin-whitening cosmetics are given. For compounds not separated, a complementary gradient elution (B) using the same solvents is proposed. Between 2004 and 2009, a market survey on "skin-whitening cosmetic" was performed on 150 samples and highlights that more than half of the products tested do not comply with the Cosmetic Regulation 1223/2009 (amending the Council Directive 76/768/EEC). © The Author 2015. Published by Oxford University Press.

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