http://www.recercat.cat:80/handle/2072/179327 Tue, 21 May 2013 19:41:58 GMT 2013-05-21T19:41:58Z http://www.recercat.cat:80/bitstream/id/44949/ http://www.recercat.cat:80/handle/2072/179327 http://www.recercat.cat:80/handle/2072/210380 Positive Outcomes Influence the Rate and Time to Publication, but Not the Impact Factor of Publications of Clinical Trial Results Suñé Martin, Maria Pilar; Suñé i Negre, Josep M. (Josep Maria); Montoro Ronsano, José Bruno Objectives: Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. Methods and Findings: All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved), negative (when no statistical significance was achieved or it favored control drug) and descriptive (for non-controlled studies). Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785). Study results were identified for 68·9% of all completed clinical trials (541/785). Publication rate was 84·9% (180/212) for studies with results classified as positive and 68·9% (128/186) for studies with results classified as negative (p<0·001). Median time to publication was 2·09 years (IC95 1·61<br>2·56) for studies with results classified as positive and 3·21 years (IC95 2·69<br>3·70) for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55<br>2·55). No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141<br>28·409) and negative result studies (median 8·266, interquartile range: 4·135<br>17·157). Conclusions: Clinical trials with positive outcomes have significantly higher rates and shorter times to publication than those with negative results. However, no differences have been found in terms of impact factor. http://www.recercat.cat:80/handle/2072/210380 http://www.recercat.cat:80/handle/2072/203118 Clinical pharmacokinetics of mycophenolic acid and its metabolites in solid organ transplant recipient Colom Codina, Helena; Lloberas Blanch, Núria; Caldés, Ana; Andreu, Franc; Torras Ambròs, Joan; Oppenheimer Salinas, Federico; Sanchez-Plumed, Jaime; Gentil, Miguel A.; Kuypers, Dirk R.; Brunet i Serra, Mercè; Ekberg, Henrik; Grinyo Boira, Josep M. Mycophenolate mofetil (MMF), an ester prodrug of the immunosuppressant mycophenolic acid (MPA), is widely used for maintenance immunosuppressive therapy and prevention of renal allograft rejection in renal transplant recipients.MPA inhibits inosine monophosphate dehydrogenase (IMPDH), an enzyme involved in the “de novo” synthesis of purine nucleotides, thus suppressing both T-cell and B-cell proliferation. MPA shows a complex pharmacokinetics with considerable interand intra- patient by between- and within patient variabilities associated to MPA exposure. Several factors may contribute to it. The pharmacokinetic modeling according to the population pharmacokinetic approach with the non-linear mixed effects models has shown to be a powerful tool to describe the relationships between MMF doses and the MPA exposures and also to identify potential predictive patients’ demographic and clinical characteristics for dose tailoring during the post-transplant immunosuppresive treatment.; Podeu consultar el llibre complet a: http://hdl.handle.net/2445/32393 http://www.recercat.cat:80/handle/2072/203118 http://www.recercat.cat:80/handle/2072/203079 Recent advances in pharmaceutical sciences II Muñoz-Torrero López-Ibarra, Diego (ed.); Haro Bautista, Diego (ed.); Vallès Xirau, Joan, 1959- http://www.recercat.cat:80/handle/2072/203079 http://www.recercat.cat:80/handle/2072/203078 Recent advances in pharmaceutical sciences Muñoz-Torrero López-Ibarra, Diego (ed.) http://www.recercat.cat:80/handle/2072/203078 http://www.recercat.cat:80/handle/2072/202534 Clinical pharmacokinetics of mycophenolic acid and its metabolites in solid organ transplant recipient Colom Codina, Helena; Lloberas Blanch, Núria; Caldés, Ana; Andreu, Franc; Torras Ambròs, Joan; Oppenheimer Salinas, Federico; Sanchez-Plumed, Jaime; Gentil, Miguel A.; Kuypers, Dirk R.; Brunet i Serra, Mercè; Ekberg, Henrik; Grinyo Boira, Josep M. Mycophenolate mofetil (MMF), an ester prodrug of the immunosuppressant mycophenolic acid (MPA), is widely used for maintenance immunosuppressive therapy and prevention of renal allograft rejection in renal transplant recipients.MPA inhibits inosine monophosphate dehydrogenase (IMPDH), an enzyme involved in the “de novo” synthesis of purine nucleotides, thus suppressing both T-cell and B-cell proliferation. MPA shows a complex pharmacokinetics with considerable interand intra- patient by between- and within patient variabilities associated to MPA exposure. Several factors may contribute to it. The pharmacokinetic modeling according to the population pharmacokinetic approach with the non-linear mixed effects models has shown to be a powerful tool to describe the relationships between MMF doses and the MPA exposures and also to identify potential predictive patients’ demographic and clinical characteristics for dose tailoring during the post-transplant immunosuppresive treatment.; Podeu consultar el llibre complet a: http://hdl.handle.net/2445/32393 http://www.recercat.cat:80/handle/2072/202534 http://www.recercat.cat:80/handle/2072/195731 Ensenyament presencial a l'aula. Anàlisi metodològica i avaluació dels coneixements adquirits Barbé Rocabert, Coloma; Aróztegui Trenchs, Montserrat; Halbaut, Lyda; García Montoya, Encarna; Torres Farrés, Esther; Suñer Carbó, Joaquim; Aparicio Pelegrin, R.M.; Ticó Grau, Josep R.; Penzo, Wilma; Vendrell i Gómez, Pere; Sánchez González, S. El treball que es presenta gira a l'entorn de la classe teòrica presencial, dissenyada segons les possibilitats d'aquesta classe quan es planteja per a un nombre elevat d'alumnes i es pretén la màxima implicació de l'estudiant. Analitza l'assistència a classe, el tipus de classe teòrica que s'imparteix i els resultats de les iniciatives preses per incentivar la participació activa. Els resultats demostren que els plantejaments didàctics són globalment adients en aquest context, fet que es reflecteix en la bona acceptació per part de l'alumne de les iniciatives proposades i en la millora notable del rendiment acadèmic, objectiu primordial del projecte REDICE-06 titulat Deconstrucció/construcció de l'ensenyament presencial, del qual forma part. http://www.recercat.cat:80/handle/2072/195731 http://www.recercat.cat:80/handle/2072/179530 Technological, biopharmaceutical and pharmacokinetic advances: new formulations of application on the skin and oral mucosa Calpena Campmany, Ana Cristina; Clares, Beatriz; Fernández, Francisco Currently a growing interest to improve the pharmacological therapy exists, not only by the production and the appearance of new drugs, but guaranteeing that the uses of those which already exist, become more effective. In fact, the conventional pharmaceutical formulations of different drugs present a few secondary effects due to oral administration. In order to avoid these undesired side effects, the purpose of current therapeutic is the development and research of formulations as an alternative to others routes of administration. Therefore, in spite of the undoubtedly complete parenteral absorption, the transdermal and transbuccal routes appear to be a rather attractive alternative to provide an efficient absorption. In this chapter a new technological, biopharmaceutical and pharmacokinetic approach of strategies for application on skin and buccal mucosa are reported. In the future new transdermal drug delivery systems will emerge to be more effective, equipped with an improved aesthetic appearance, better adherence and greater diffusion. But to reach these aims, it is necessary previous knowledge of histology and physiology of skin, and factors involved in the penetration of drugs through it.; Podeu consultar el llibre complet a: http://hdl.handle.net/2445/32392 http://www.recercat.cat:80/handle/2072/179530 http://www.recercat.cat:80/handle/2072/179529 Resveratrol: A polyphenol with multiple effects Planas i Rosselló, Joana M.; Colom Codina, Helena; Juan i Olivé, M. Emília trans-Resveratrol (trans-3,5,4'-trihydroxystilbene) is a natural polyphenol that occurs in grapes, berries, peanuts, and several traditional medicines. A number of studies have demonstrated that this polyphenol holds promise against numerous age-associated diseases including cancer, diabetes, Alzheimer, cardiovascular and pulmonary diseases. In view of these studies, resveratrol's prospects for use in the clinics are rapidly accelerating. This review summarizes our work on the mechanisms involved in the intestinal absorption and its population pharmacokinetics. Finally, various targets of resveratrol and its therapeutic potential are described.; Podeu consultar el llibre complet a: http://hdl.handle.net/2445/32392 http://www.recercat.cat:80/handle/2072/179529