Roberta Pacifici

Istituto Superiore di Sanità, Roma, Latium, Italy

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Publications (308)1035.47 Total impact

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    ABSTRACT: Perinatal exposure to one or more drugs of abuse can affect the neonate temporarily or permanently. In addition to meconium, the evaluation of perinatal exposure to drugs of abuse has been achieved by testing biological matrices coming from the newborn (neonatal hair) and from the pregnant or nursing mother (maternal hair and breast milk). These matrices have the advantage of noninvasive collection and account for a sizable time window of active and passive exposure. Sensitive and specific analytical methods are required to determine minute amounts of drugs of abuse and metabolites in these matrices. The present manuscript reviews the newest analytical methods developed to detect drugs of abuse as well as ethanol biomarkers in maternal and neonatal hair and breast milk.
    Bioanalysis 05/2015; 7(10):1273-97. DOI:10.4155/bio.15.60 · 3.03 Impact Factor
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    ABSTRACT: Sildenafil and bosentan are increasingly used for the treatment of pulmonary arterial hypertension (PAH) in HIV-infected patients. However, concerns exist about pharmacokinetic interactions among sildenafil, bosentan and antiretroviral drugs, including protease inhibitors (PI). We describe here the case of an HIV-infected patient with PAH, who was co-administered bosentan 125 mg twice daily and sildenafil 40 mg three times per day, together with a ritonavir-boosted PI-based antiretroviral therapy; plasma levels of bosentan, sildenafil, N-desmethylsildenafil, and PI were measured. The patient had a sildenafil Cthrough and Cmax of 276.94 ng/mL and 1733.19 ng/mL, respectively. The Cthrough and the Cmax of bosentan were 1546.53 ng/mL and 3365.99 ng/mL, respectively. The patient was able to tolerate as high sildenafil blood concentrations as 10 times those usually requested and did not report any significant adverse reaction to sildenafil during the follow-up period. Therapeutic drug monitoring should be considered during sildenafil therapy in patients concomitantly treated with ritonavir-boosted PI.
    Infectious disease reports 02/2015; 7(1):5822. DOI:10.4081/idr.2015.5822
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    ABSTRACT: We developed and validated an ultra-high-pressure liquid chromatography tandem mass spectrometry method to identify and quantify 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid glucuronide in hair of cannabis consumers. After hair washing with methyl alcohol and diethyl ether and subsequent addition of amiodarone as internal standard hair samples were treated with 500 μl VMA-T M3 buffer reagent for 1 h at 100 °C. After cooling, 10 μl VMA-T M3 extract were injected into chromatographic system. Chromatographic separation was carried out on a reversed phase column using a linear gradient elution with two solvents: 5 mM ammonium formate pH 3.0 (solvent A) and 0.1% formic acid in acetonitrile (solvent B). The flow rate was kept constant at 0.4 ml/min during the analysis. The separated analytes were detected with a triple quadrupole mass spectrometer operated in multiple reaction monitoring mode via positive electrospray ionization. Linear calibration curves were obtained for 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid glucuronide with correlation coefficients (r2) of 0.99 and a limit of quantification of 0.25 pg/mg hair. Analytical recovery was between 79.6% to 100.7% and intra and inter-assay imprecision and inaccuracy were always lower than 15%. Ultra-high-pressure liquid chromatography tandem mass spectrometry analysis of 20 different hair samples of cannabis consumers disclosed the presence of 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid glucuronide in the range of 0.5-8.6 pg/mg hair. These data provided a good start to consider 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid glucuronide as alternative hair biomarker of cannabis consumption.
    Forensic Science International 01/2015; 249C. DOI:10.1016/j.forsciint.2015.01.011 · 2.12 Impact Factor
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    1° 12/2014; Istituto Superiore di Sanità.
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    ABSTRACT: A pilot study of market surveillance in Senegal has been performed analyzing best selling drugs from an official pharmacy and a street market in two principal cities of Senegal and some traditional preparations from herbal medicine from the same market. A simple and rapid gas chromatography method with mass spectrometry detection has been applied after a liquid-liquid extraction of pharmaceutical products and traditional preparations at acidic, neutral and basic pH with chloroform-isopropanol (9:1, v/v). The assay was validated in the range from 10mg to 250mg/g powder preparations with good determination coefficients (r(2)≥0.99) for the calibration curves. At three concentrations spanning the linear dynamic ranges of the calibration curves, mean recoveries of substances under investigation were always higher than 90% and intra-assay and inter-assay precision and accuracy were always better than 15%. The four best selling drugs purchased from a Dakar local pharmacy exactly contained the amount of active principles reported in the respective labels while the best selling drugs freely purchased from Kaolack market contained an amount of active ingredients lower than that declared on the label. No pharmacological active compound, but salicylic acid was found in one of the traditional herbal preparations. This pilot study showed that whereas official drugs sold in pharmacies at prices accessible for a very few portion of the population contained the amount of active principles as reported in the labels, those from street market bought by the majority of population contained an amount of active ingredients lower than that declared on the label and finally traditional herbal preparations seldom contain pharmacological active principles. Copyright © 2014 Elsevier B.V. All rights reserved.
    Journal of Pharmaceutical and Biomedical Analysis 11/2014; 104C:62-66. DOI:10.1016/j.jpba.2014.11.016 · 2.83 Impact Factor
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    ABSTRACT: Synthetic cathinones have been markedly present in the Spanish drug market in recent years. These substances can be easily obtained in "smart shops", smoke shops, gas stations and web sites where they can be bought and received anonymously avoiding normal law controls. For the first time we present a case of a neonatal withdrawal syndrome in a baby born to a woman who was a chronic consumer of 4-methylethcathinone. The newborn presented with increased jitteriness and irritability, highpitched cry, hypertonia in the limbs and brisk tendon reflexes. 4-Methylethcathinone was identified and quantified by liquid chromatography tandem mass spectrometry in the four subsequent 3cm segments of maternal hair (4.3, 4.0, 4.0 and 3.9ng/mg hair starting from most proximal segment) accounting for maternal consumption during the whole pregnancy and before and in neonatal meconium (0.7ng/g) confirming fetal exposure during intrauterine life. Methadone and its metabolite were also measured in maternal and neonatal matrices. Counseling pregnant women and women who may become pregnant on the consequences of fetal drug exposure to new designer drugs like 4-methylethcathinone is critical to preventing poor neonatal outcomes. This case report is informative to those studying designer drugs and those clinically involved with pregnant women abusing psychoactive substances. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
    Forensic Science International 10/2014; 245C:e33-e35. DOI:10.1016/j.forsciint.2014.10.027 · 2.12 Impact Factor
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    09/2014; 4. DOI:10.1016/j.ijcme.2014.07.005
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    ABSTRACT: It has been known for a long time that cigarette tobacco contains naturally occurring radioactive nuclides such as Pb and Po. In this study, the concentrations of Pb and Po in the 10 most widely sold cigarette brands in Italy during the year 2010 were measured, and the effective dose to smokers has been calculated. The results of this study show that Pb concentration ranged from 11.6 to 20.0 mBq cig with an arithmetic mean of 14.6 mBq cig, while the activity concentration of Po ranged from 13.1 to 19.0 mBq cig with an arithmetic mean of 15.7 mBq cig, thus confirming previous results and showing that the radioactivity concentration was not reduced in the last few years. The annual effective dose for a typical smoker consuming 20 cigarettes per day ranged from an average of 55 μSv y to about 81 μSv y. It is finally put in evidence the need to improve the knowledge about crucial data needed for accurate dose assessment deriving from the inhalation of both radioisotopes contained in the cigarettes, namely the dose conversion coefficients, which strongly depend on several parameters such as the inhalation speed through the mouth, the real fraction of radionuclide transferred from cigarette to mainstream smoke, the lung absorption behavior of the radioisotopes inhaled with mainstream smoke, and the AMAD of particles inhaled by smokers.
    Health Physics 09/2014; 107(3):195-9. DOI:10.1097/HP.0000000000000104 · 0.77 Impact Factor
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    ABSTRACT: A procedure based on ultra-high-pressure liquid chromatography tandem mass spectrometry has been developed for the determination of mescaline, N,N-dimethyltryptamine, psilocin, psilocybin, salvinorin A in hair of consumers of psychedelic vegetal material such peyote or trichocereus cacti, psilocybe mushrooms, Salvia divinorum or psychedelic beverage ayahuasca. After hair washing with methyl alcohol and diethyl ether and subsequent addition of mescaline-d9 and 3,4-methylenedioxypropylamphetamine as internal standards, hair samples were treated with 250μl VMA-T M3 reagent for 1h at 100°C. After cooling, 100μl M3 extract were diluted with 400μl water and a volume of 10μl was injected into chromatographic system. Chromatographic separation was achieved at ambient temperature using a reverse-phase column and a linear gradient elution with two solvents: 0.3% formic acid in acetonitrile and 5mM ammonium formate pH 3. The mass spectrometer was operated in positive ion mode, using multiple reaction monitoring via positive electrospray ionization. The method was linear from the limit of quantification (0.03-0.05ng/mg depending on analyte under investigation) to 10ng/mg hair, with an intra- and inter-assay imprecision and inaccuracy always less than 15% and an analytical recovery between 79.6% and 97.4%, depending on the considered analyte. Using the validated method, mescaline was found in concentration range of 0.08-0.13ng/mg in hair of peyote smokers, 3.2ng salvinorin A per mg hair were determined in hair from a S. divinorum smoker, 5.6ng N,N-dimethyltryptamine per mg hair from an ayahuasca user and finally 0.8ng psilocybin per ng hair of a psilocybe consumer.
    Journal of Pharmaceutical and Biomedical Analysis 08/2014; 100C:284-289. DOI:10.1016/j.jpba.2014.08.006 · 2.83 Impact Factor
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    ABSTRACT: Hair testing is a useful tool to investigate the prevalence of unsuspected chronic exposure to drugs of abuse in pediatric populations and it has been applied to three different cohorts of children from Barcelona, Spain along fifteen years to evaluate eventual changes in this exposure. Children were recruited from three independent studies performed at Hospital del Mar (Barcelona, Spain) and approved by the local Ethics Committee. Hair samples were collected from the first 187 children cohort (around 4 years of age) in 1998, from the second 90 children cohort (1.5-5 years of age) in 2008 and from the third 114 children cohort (5-14 years of age) in 2013. Hair samples were analysed for the presence of opiates, cocaine, amphetamines, and cannabis by validated methodologies using gas or liquid chromatography-mass spectrometry. Familiar sociodemographics and eventual consumption of drugs of abuse by parents, and caregivers were recorded. Hair samples from 24.6% children in 1998 were positive for any drug of abuse (23.0% cocaine), 25.5% in 2008 (23.3% cocaine), and 28.1% in 2013 (20.1% cocaine and 11.4% cannabis). In none of the cohorts, parental sociodemographics were associated with children exposure to drugs of abuse. The results of the three study cohorts demonstrated a significant prevalence of unsuspected pediatric exposure to drugs of abuse which mainly involved cocaine maintained along fifteen years in Barcelona, Spain. We recommend to be aware about unsuspected passive exposure to drugs of abuse in general population and to use general or selected hair screening to disclose exposure to drugs of abuse in children from risky environments to provide the basis for specific social and health interventions.
    International Journal of Environmental Research and Public Health 08/2014; 11(8):8267-8275. DOI:10.3390/ijerph110808267 · 1.99 Impact Factor
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    ABSTRACT: Only a few studies have provided information on awareness, use, and harm perceptions of e-cigarettes in Europe. We fill the knowledge gap in Italy. We used data from a face-to-face survey conducted in 2013 of a sample of 3,000 individuals, representative of the Italian population aged a parts per thousand yen15 years (51.1 million inhabitants). Awareness of e-cigarettes was 91.1%; it was lowest among women (87.8%), the elderly (78.4%), those with less education (84.1%), and never-smokers (89.0%). Ever e-cigarette use was 6.8% overall and was inversely related to age, whereas no significant difference was observed according to sex. With regard to smoking status, 2.6% of never-smokers, 7.0% of ex-smokers, and 20.4% of current smokers tried the e-cigarette at least once. Regular e-cigarette use was 1.2% overall, 1.5% among men, and 0.9% among women, and it was highest among young (2.4%) and current smokers (3.7%). Among 36 e-cigarette regular users, 22.0% did not change their smoking habit, 67.7% reduced traditional cigarette consumption, and 10.4% quit smoking. After fewer than 3 years from the opening of the first Italian e-cigarette shop, more than 45 million Italians have heard about e-cigarettes, 3.5 million have tried e-cigaretts, and more than 600,000 Italians regularly use e-cigarettes. Three out of 4 e-cigarette users reported to have favorably modified their smoking habit; however, 90% of users did not quit smoking as a consequence of starting vaping e-cigarettes. Almost 900,000 Italian never-smokers, particularly young never-smokers, have tried this new and potentially addictive product at least once.
    Nicotine & Tobacco Research 07/2014; 16(12). DOI:10.1093/ntr/ntu124 · 2.81 Impact Factor
  • 06/2014; 1(2):82-93. DOI:10.3390/cosmetics1020082
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    ABSTRACT: Introduction Disclosing chronic use of cannabis has always been a difficult task due to the fact that hair testing of THC alone is not conclusive of use and hair testing of THC-COOH require specific and sensitive instrumentation and laboratory skill, not available for many analytical laboratories. We hypothesized the presence of THC-COOH glucuronide in hair as possible alternative biomarker of repeated consumption of cannabis products. Methods We developed and validated an ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method to identify and quantify THC-COOH glucuronide in hair after applying one hour digestion of 25 mg keratin matrix with M3 (Comedical Spa, Italy) reagent at 100°C, using deuterated THC-COOH glucuronide as internal standard. An amount of 10 μl was injected in the ULPC-MS/MS system. Chromatographic separation was carried out on a Acquity UPLC HSS C18 column (2,1 mm × 150 mm, 1.8 μm) using a linear gradient elution with two solvents:0.1% formic acid in acetonitrile (solvent A) and 5 mM ammonium formate pH 3 (solvent B). The flow rate was kept constant at 0.40 mL/min during the analysis. The separated analytes were detected with a triple quadrupole mass spectrometer operated in multiple reaction monitoring (MRM) mode via positive electrospray ionization (ESI). The applied ESI conditions were the following: capillary voltage 1,3 kV, desolvation temperature 600 °C, source temperature 150 °C, cone gas flow rate 20 L/h, desolvation gas flow rate 1000 L/h and collision gas flow rate 0.13 mL/min, cone voltage of 65 V. Following transitions were considered: 521.2→345.03 (Collision energy:16), 521.2 →327.07 (Collision energy: 22),521.2 → 299.09 (Collision energy: 32), with the first one used for quantification. Results Linear calibration curves were obtained for THC-CCOH glucuronide with correlation coefficients (r2) of 0.99 and a LOQ of 0.1 pg/mg hair. Analytical recovery was between 70.9 and 100.7%. Intra and inter-assay imprecision and inaccuracy were always lower than 10%. No additional peaks due to endogenous substances which could have interfered with the detection of the analytes under investigation were observed in drug-free hair samples. No psychoactive drugs other than the compounds under investigation interfered with the assay. Blank hair samples injected after the highest point of the calibration curve did not present any traces of carryover. The matrix effect in quality control samples ranged from 80 to 101%. Preliminary analysis on 9 different hair samples of consumers disclosed the presence of THC-CCOH glucuronide in the range of 0.30–1.22 pg/mg with by median value of 0.58 pg/mg hair. Conclusions Simple extraction, identification and quantification of THC-COOH glucuronide in hair by UPLC-MS/MS was developed, validated and tested for its feasibility in clinical samples and provided a good start to consider THC-CCOH glucuronide as alternative hair biomarker of repeated cannabis consumption.
    06/2014; 26(2):S12. DOI:10.1016/S2352-0078(14)70027-7
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    ABSTRACT: Abstract Background: Ethyl glucuronide (EtG) measurement in neonatal meconium has emerged as a reliable marker to objectively assess prenatal exposure to maternal ethanol complementary to fatty acid ethyl ester (FAEEs) measurement. The detection of EtG in meconium is currently a lengthy, difficult and expensive process using liquid chromatography tandem mass spectrometry (LC-MS/MS) as the analytical procedure. An enzyme-linked immunosorbent assay (ELISA) for the identification of EtG in meconium was developed, validated and applied to authentic meconium specimens from newborns collected in Europe. Methods: The ELISA procedure was calibrated using 0.45, 0.9, 1.35 and 1.8 nmol/g (100, 200 300 and 400 ng/g) standards. Meconium (0.25 g) was mixed thoroughly, with extraction buffer (pH 7.3; 0.5 mL). The tube was capped, sonicated, centrifuged and the supernatant was decanted. An aliquot of the extract (50 μL) was placed in the well of the microplate followed by enzyme conjugate (150 μL). The plate was incubated for 1 h, washed with deionized water, dried and substrate (200 μL) was added. After 30 min incubation, stop solution was added and the plate was read at 450 nm and 650 nm. Samples were also analyzed for EtG and FAEEs by validated LC-MS/MS assays. Results: Using an EtG cut-off of 0.9 nmol/g for both ELISA screening test and confirmatory LC-MS/MS, immunoassay sensitivity was 100%; specificity 78%; positive-predictive value (PPV) 29% and negative-predictive value (NPV) 100%. Conclusions: The assay is proposed as a preliminary screening test for the meconium of newborns suspected of being born to mothers drinking alcohol during pregnancy.
    Clinical Chemistry and Laboratory Medicine 03/2014; 52(8). DOI:10.1515/cclm-2013-1087 · 2.96 Impact Factor
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    ABSTRACT: We performed a descriptive survey on the use of dietary supplements among Italian sporting club amateur athletes to obtain information on the prevalence of use and beliefs of athletes on their usefulness and danger to plan information strategies. The DOXA Institute selected and interviewed 289 amateur athletes (median age 35 years, range 18–57) in sport facilities practising various sports. Subjects were asked about their beliefs on the use of supplements for athletic performance, and the related benefits and side effects. Sixty-seven percent of athletes reported that physical performance is increased with a balanced diet, 89.6% that supplements can further increase it and 69.9% that supplements are widespread and not difficult to buy. Amateur athletes believed that about 50% of athletes of both sexes use supplements at least occasionally, that the highest prevalence of use is among those aged 30–44 years and the lowest is among teenagers. Sixty-two percent of athletes reported an increase of use over the last few years, 40.5% that supplements had no adverse effects, 55.7% that some athletes abuse supplements at least occasionally and 61.3% that medical advice is not obtained before use. Supplements containing minerals are reported as most useful followed by those with vitamins and amino acids/proteins. Probiotics/phytotherapics and meal replacements were less frequently used. Thus, in the opinion of amateur athletes attending sporting clubs, supplement use is widespread and non-professional athletes are poorly informed of the potential adverse effects of supplementation, supporting the need for correct scientific information that can balance the marketing that encourages its use.
    03/2014; 13(1):29-34. DOI:10.1007/s13749-014-0003-8
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    ABSTRACT: Hair testing was used to investigate the prevalence of unsuspected exposure to drugs of abuse in a group of children presenting to an urban paediatric emergency department without suggestive signs or symptoms. Hair samples were obtained from 114 children between 24 months and 10 years of age attending the emergency room of Hospital del Mar in Barcelona, Spain. Hair samples from the accompanying parent were also collected. The samples were analyzed for the presence of opiates, cocaine, amphetamines, and cannabinoids by ultra-performance liquid chromatography-tandem mass spectrometry. Parental sociodemographics and possible drug of abuse history were recorded. Hair samples from twenty-three children (20.1%) were positive for cocaine (concentration range 0.15-3.81 ng/mg hair), those of thirteen children (11.4%) to cannabinoids (D9-THC concentration range 0.05-0.54 ng/mg hair), with four samples positive to codeine (0.1-0.25 ng/mg hair), one positive for 2.09 ng methadone per mg hair and one to 6-MAM (0.42 ng/mg hair) and morphine (0. 15 ng/mg hair) . In 69.5 and 69.2% of the positive cocaine and cannabinoids cases respectively, drugs was also found in the hair of accompanying parent. Parental sociodemographics were not associated with children exposure to drugs of abuse. However, the behavioural patterns with potential harmful effects for the child's health (e.g., tobacco smoking, cannabis, benzodiazepines and/or antidepressants use) were significantly higher in the parents of exposed children. In the light of the obtained results (28% overall children exposure to drugs of abuse) and in agreement with 2009 unsuspected 23% cocaine exposure in pre-school children from the same hospital, we support general hair screening to disclose exposure to drugs of abuse in children from risky environments to provide the basis for specific social and health interventions.
    International Journal of Environmental Research and Public Health 02/2014; 11(2):2288-98. DOI:10.3390/ijerph110202288 · 1.99 Impact Factor
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    ABSTRACT: To validate the health and lifestyle questionnaire answered by donors to a human milk bank with respect to the presence of illegal drugs, nicotine, and caffeine levels in donor milk. A total of 400 human milk samples from 63 donors were analyzed by liquid chromatography tandem mass spectrometry for the presence of 14 illegal drugs, nicotine, and caffeine. Demographics and clinical and lifestyle data (illegal drugs, tobacco, and caffeinated beverage use) were collected from the required screening questionnaire of a human milk bank. The relationship between the 2 evaluation techniques was determined. Illegal drugs were not found in donor milk. Nicotine (46.1 ng/mL) and cotinine (138.6 ng/mL) were quantified in one milk sample from a donor who did not report tobacco use in the questionnaire (1.6% false negative). Caffeine was detected in 45.3% (181/400) of the total milk samples, with a mean concentration of 496 ± 778 ng/mL. The sensitivity and specificity of the questionnaire to detect caffeine in donor milk was 46% and 77%, respectively. The lifestyle questionnaire is reliable for the assessment of illicit drug use by donors to a human milk bank, but there are certain limitations regarding the identification of second-hand smoke exposure and the disclosure of consumption of caffeinated beverages. Data such as smoking habits of partners, type and volume of beverage or food containing caffeine, method of preparation, and time of day of consumption should be collected by the questionnaire.
    The Journal of pediatrics 12/2013; 164(4). DOI:10.1016/j.jpeds.2013.11.043 · 3.74 Impact Factor

Publication Stats

8k Citations
1,035.47 Total Impact Points

Institutions

  • 1991–2015
    • Istituto Superiore di Sanità
      • • Department of Therapeutic Research and Medicines Evaluation
      • • Clinical Biochemistry and Molecular Biology Unit
      Roma, Latium, Italy
  • 2009–2013
    • University of Pavia
      • Department of Public Health, Neuroscience, Experimental and Forensic Medicine
      Ticinum, Lombardy, Italy
    • The Ohio State University
      Columbus, Ohio, United States
  • 2012
    • Italian National Institute of Statistics
      Roma, Latium, Italy
  • 2005–2011
    • Parc de Salut Mar
      Barcino, Catalonia, Spain
  • 2003–2010
    • University Pompeu Fabra
      • Department of Experimental and Health Sciences
      Barcino, Catalonia, Spain
  • 2007–2009
    • Autonomous University of Barcelona
      • Department of Pediatrics, Obstetrics, Gynecology and Preventive Medicine
      Cerdanyola del Vallès, Catalonia, Spain
  • 1992–2009
    • Sapienza University of Rome
      Roma, Latium, Italy
  • 2006
    • University of Verona
      Verona, Veneto, Italy
    • Emory University
      • Atlanta Veterans Affairs Medical Center
      Atlanta, GA, United States
  • 2004
    • Mario Negri Institute for Pharmacological Research
      • Department of Epidemiology
      Milano, Lombardy, Italy
  • 2002
    • Institut Marqués, Spain, Barcelona
      Barcino, Catalonia, Spain
  • 1985–2001
    • Washington University in St. Louis
      • • Division of Bone and Mineral Diseases
      • • Department of Medicine
      San Luis, Missouri, United States
  • 1999
    • Barnes Jewish Hospital
      San Luis, Missouri, United States
  • 1998
    • Catholic University of the Sacred Heart
      • School of Obstetrics and Gynecology
      Milano, Lombardy, Italy
  • 1994–1998
    • Università degli Studi di Messina
      • Dipartimento di Medicina Clinica e Sperimentale
      Messina, Sicily, Italy
  • 1995
    • Baylor College of Medicine
      • Department of Medicine
      Houston, Texas, United States
  • 1993
    • University of Alabama at Birmingham
      Birmingham, Alabama, United States
    • Ospedale Santo Spirito
      Roma, Latium, Italy