Results 141 to 150 of about 2,864,107 (356)
An IQ Consortium Perspective on the FDA Guidance for Assessment of Pharmacokinetics in Participants With Impaired Renal Function
Clinical Pharmacology &Therapeutics, EarlyView.The FDA published guidance on assessing pharmacokinetics (PK) in participants with impaired renal function in 2024. The IQ CPLG Organ Impairment Working Group summarized the industry’s perspective on this guidance by highlighting a few key updates in the 2024 guidance, including: (1) the recommendation of using estimated glomerular filtration rate ...Yan Jin, Ashish Sharma, Mariam A. Ahmed, Sravanthi Cheeti, Ying Ou, Damayanthi Devineni, Yizhe Chen, Jitendra S. Kanodia, Yasmeen Abouelhassan, Nadia Noormohamed, Jin Zhou, Patrick Marroum, Vaishali Sahasrabudhe, Islam R. Younis +13 morewiley +1 more sourceBuilding a Robust Investigator‐Initiated Platform: The I‐CARE Experience
Clinical Pharmacology &Therapeutics, EarlyView.Investigator‐initiated studies that include information collected by patients are rising, but limited data is available on patient and investigator experience in this setting. The I‐CARE cohort included patients with inflammatory bowel disease (IBD) monthly collecting clinical information in 15 countries for up to 6 years.Julien Kirchgesner, Laurent Beaugerie, Cédric Baumann, Filip Baert, Jean‐François Rahier, Daniel Bergemalm, Fiorella Cañete, Bénédicte Caron, Marta Cossignani, Sandra Dias, Klaudia Farkas, Parker Girod, Idan Goren, Tom Holvoet, Susanne Krasz, Aditi Kumar, Peter Rimmer, Juliette Sheridan, Jessica Thut, Mathieu Uzzan, Nikos Viazis, Petra Weimers, Edyta Zagórowicz, Anne Buisson, Luisa Avedano, Helene Rousseau, Laurent Peyrin‐Biroulet, Shaji Sebastian, I‐CARE Collaborator Group, Jean‐Marc Gornet, Laurent Beaugerie, Sebastian Shaji, Laurent Peyrin‐Biroulet, Jean‐Marie Reimund, Xavier Hebuterne, Aurélien Amiot, Franco Armelao, Pierre Blanc, Guillaume Pineton De Chambrun, Konstantinos Karmiris, Sohail Shariq, Nikolaos Viazis, Jimmy Limdi, Piotr Eder, Georgios Michalopoulos, Andrew Bell, Livia Biancone, Marie Dewitte, Zia Mazhar, Denis Franchimont, Stephane Nancey, Gilles Macaigne, Maria Beatrice Principi, Mathurin Fumery, Gareth Parkes, Jean‐Christophe Valats, Glen Doherty, Guillaume Bouguen, Tamás Molnar, Hersin Tsai, Mohsin Gangi, Natalia Pedersen, Frédéric Heluwaert, Richard Shenderey, Sebastian Zeissig, Jeffrey Butterworth, Fabiana Castiglione, Lynsey Corless, Camille Zallot, Filip Baert, Salil Singh, Sunil Sonwalkar, Julie Burton, Elizabeth Clayton, Jean‐François Rahier, Deven Vani, Renata D’Inca, Guy Bellaiche, Martine De Vos, Julien Kirchgesner, Uri Kopylov, Triana Lobaton, Christophe Locher, Gerassimos Mantzaris, George Abouda, Katie Smith, Angeliki Theodoropoulou, Emma Wesley, Joëlle Bonnet, David Elphick, Cyrielle Gilletta, John Gordon, David Laharie, Antoine Nakad, Ambrogio Orlando, Patrick Dubois, Peter Hasselblatt, Christophe Michiels, Cathryn Preston, Anca Staicu, Lucine Vuitton, Mehdi Kaassis, Ally Speight, Deb Ghosh, Mark Löwenberg, Nicolas Mathieu, Anne‐Laure Pelletier, Anne Phillips, Fernando Magro, Romain Altwegg, Irit Avni Biron, Jonathon Landy, Maria Nachury, Achuth Shenoy, Caroline Trang, Vered Abitbol, Georgios Bamias, Klaudia Farkas, Christian Maaser, Ariella Shitrit, Britta Siegmund, Jérôme Filippi, Colm O’morain, Henit Yanai, Laurent Costes, David Hobday, Zoltán Szepes, Emma Calabrese, Helen Dallal, Michael Fung, Arvind Ramadas, Bijay Baburajan, Konrad Koss, Christophe Barberis, Anthony Buisson, Morgane Amil, Paola Balestrieri, Matthew Johnson, Maria Tzouvala, Stéphanie Viennot, Andy Li, Ferenc Nagy, Nick Thompson, Laurent Alric, Sunil Samuel, Anne Bourrier, Elise Chanteloup, Emilie Del Tedesco, Marcus Harbord, Alan Lobo, Sally Myers, Richard Pollok, Tariq Ahmad, Rakesh Chaudhary, Christos Karakoidas, Edouard Louis, Ashraf Soliman, Carmen Stefanescu, Georgios Theocharis, Stijn Vanden Branden, Belén Beltran, Yoram Bouhnik, Arnaud Bourreille, Joana Branco, Ben Colleypriest, Rami Eliakim, Paul Knight, Aoibhlinn O’toole, Virgina Robles, Konstantinos Triantafyllou, Marta Maia Bosca, Guy Lambrecht, Lucia Marquez Mosquera, Simon Panter, Aikaterini Pappa, Marion Simon, Ganesh Sivaji, Christophe Bellanger, Arthur Belle, Natalia Borruel, Laurence Egan, Harald Peeters, Daniel Sharpstone, Ramesh Arasaradnam, José Manuel Benitez, Jens Frederik Dahlerup, Olga Giouleme, Javier P. Gisbert, Ulf Helwig, Miguel Minguez, Eftychia Tsironi, Angela Variola, Patrick Allen, Lucille Boivineau, Andy Cole, Nina Dib, Fernando Gomollon, Richard Johnston, Konstantinos Katsanos, Nick Kennedy, Marianne Kiszka‐Kanowitz, Ignacio Marin‐Jimenez, Pál Miheller, Pilar Nos, Othman Saraj, Lars Vinter‐Jensen, Eran Zittan, Clotilde Baudry, Xavier Calvet, Marie‐Christine Cazelles‐Boudier, Jean‐Louis Coenegrachts, Garret Cullen, Marco Daperno, Anjan Dhar, Romain Gerard, Christian Lodberg Hvas, Nanna Jensen, Nitsan Maharshak, Mark Mcalindon, Simon Mcloughlin, Miles Parkes, Kamal Patel, Armando Peixoto, Dimitrios Polymeros, Francisco Portela, Rodolfo Rocca, Philippe Seksik, Sreedhar Subramanian, Ruth Tennenbaum, Raja Atreya, Oliver Bachmann, Arthur Berger, Renáta Bor, Maire Buckley, Daniel Carpio, María Chaparro, Francesco Costa, Eugeni Domenech, Maria Esteve, Stephen Foley, Jordi Guardiola, Ioannis Koutroubakis, Tanja Kuehbacher, Cécilia Landman, Alessandro Lavagna, Noemí Manceñido, Míriam Mañosa, Maria Dolores Martín‐Arranz, Laurianne Plastaras, Maria Lia Scribano, Subhasish Sengupta, Nils Teich, My‐Linh Tran‐Minh, Evanthia Zampeli, Leila Amininejad, Teresa Arroyo, Alain Attar, Ann‐Sofie Backman, Anita Bálint, John Beckly, Shomron Ben Horin, Sónia Bernardo, Ludovic Caillo, Bénédicte Caron, María Shanika De Silva, Anna Fábián, Gionata Fiorino, Ana Gutierrez, Adi Lahat, Mohamed Masmoudi, Marco Mendolaro, Vinciane Muls, Florian Poullenot, Christopher Probert, Catherine Reenaers, Mariann Rutka, Zaman Sarwari, Joanne Sayer, Beatriz Sicilia, Helena Sousa, Catherine Van Kemseke, Ana Vieira, Yamile Zabana, Marco Astegiano, Paul Banim, Dominik Bettenworth, Médina Boualit, Jacob Broder Brodersen, Angeliki Christidou, Rachel Cooney, João Cortez Pinto, Marília Cravo, Anneline Cremer, Silvio Danese, Antonio Di Sabatino, Jan Fallingborg, Antonio Ferronato, Esther Garcia Planella, Sanjay Gupta, Jonas Halfvarson, Eran Israeli, Samantha Kestenbaum, Lone Larsen, Elisabeth Macken, Nicoletta Mathou, Ágnes Milassin, Joanna Pofelski, Chiara Ricci, Francisco Rodriguez‐Moranta, Martin Schmidt‐Lauber, Ian Shaw, Marta Soares, Heithem Soliman, Christos Triantos, Konstantinos Zografos, Anurag Agrawal, Alessandro Armuzzi, Alexandre Aubourg, Manuel Barreiro‐De Acosta, Jesús Barrio, Daniel Bergemalm, Fernando Bermejo, Giorgia Bodini, Johan Bohr, Peter Bossuyt, Dimitrios Christodoulou, Christophe Claessens, Ruth De Francisco, Santiago Garcia, Sotirios Georgopoulos, Felix Goutorbe, Chrisostomos Kalantzis, Anastasia Kourikou, Vincent Mace, Georgia Malamut, Paula Ministro, Isabelle Nion Larmurier, Elena Ricart, Mélanie Serrero, Juliette Sheridan, Petra Weimers, Vibeke Andersen, Bruno Arroja, Bernd Bokemeyer, Luis Bujanda, Thibault Degand, Carl Eriksson, Cécile Garceau, Henning Glerup, Idan Goren, Lucina Jackson, Stéphane Koch, Francisco Mesonero, Ingrid Ordas, Pauline Riviere, Simone Saibeni, João Soares, Noémie Tavernier, Klaus Theede, Bella Ungar, Elke Bästlein, Antonio Gasbarrini, Andreas Protopapas, Wolfgang Reindl, Fabrizio Bossa, Ailsa Hart, Franz‐Josef Heil, Anthony O’Connor, Bas Oldenburg, Luca Pastorelli, Stephen Patchett, Subramaniam Ramakrishnan, John de Caestecker, Ana Echarri, David Kevans, Jürgen Büning, Rosa Coelho, Jeroen Jansen, Benjamin Koslowski, Christopher Wells, Daniel Ceballos, Daan de Konig, Ingrid König, Hari Padmanabhan, Timi Patani, Raheel Qureshi, Edyta Zagorowicz, Matthieu Allez, Emmanouil Archavlis, Delphine Bonnet, Luisa Guidi, Deirdre Mcnamara, Piero Vernia, Michael Weidenhiller, Lang Alon, Trine Boysen, Charlotte Delattre, Richard Farrell, Rolf‐Achim Krüger, Thierry Paupard, Bénédicte Prost, Ida Vind, Flavio Caprioli, Vladimir Gancho, Vincent Quentin, Benjamin Avidan, Geert D’haens, Jane Mccarthy, Jonathon Snook, Konstantinos Soufleris, Frank Zerbib, Dan Carter, Annekatrien Depla, Thomas Eisenbach, Walter Fries, Nikolaos Grammatikos, Saskia Ilegems, Antonio Lopez‐Sanroman, Jacques Moreau, Gabriele Riegler, Svend Rietdijk, Marta Rocha, Isabelle Rosa, Barbara Ryan, Yelena Yeremenko, Arnaud Boruchowicz, Filipe Damião, Foteini Laoudi, Andreas Lügering, Giampiero Macarri, Konstantinos Thomopoulos, Luísa Barros, Thomas Blixt, Aurélien Garros, Sam Khorrami, Harry Sokol, Andreas Sturm, Dan Livovsky, Jochen Maul, Heinrich Miks, Vasileios Papadopoulos, Carsten Schmidt, Yifat Snir, Lise Svenningsen, Wafaa Ahmed, Yelena Broitman, Emmanuel Cuillerier, Prashant Kant, Jan Leyden, Lev Lichtenstein, Susana Lopes, Chloé Martineau, Hugh Mulcahy, Axel Schweitzer, Fiona Van Schaik, Hagar Banai, Pauline Danion, Charlotte Dulery, Herma Fidder, Claire Gay, Hervé Hagege, Florence Harnois, Søren Peter Jørgensen, Jens Müller‐Ziehm, Michail Oikonomou, Carolina Palmela, Jörg Schulze/Röske, Mark Smith, Tamar Thurm, Francesca Bresso, Hedia Brixi, John Jones, Padraig Macmathuna, Spyridon Michopoulos, Claire Painchart, Yulia Ron, Marianne Vester‐Andersen, Gonçalo Alexandrino, Norbert Börner, Mariana Cardoso, Cristina Chagas, Axel Dignaß, Iris Dotan, Charlotte Hedin, Pantelis Karatzas, Panagiotis Kasapidis, Károly Palatka, Georgios Sakizlis, Ana Wilson, Nick Bosanko, Paulo Caldeira, Charlotte Gagniere, Louise Libier, Camille Meunier, Gero Moog, Audrey Pasquion, Roberta Pica, Ayesha Akbar, Nadia Arab, Guillaume Cadiot, João Carvalho, Claire Charpignon, Klaus Fellermann, Sigal Fishman, Gerald Fraser, Nathan Gluck, Mark Hoesl, Jarosław Kierkus, Maria Klopocka, Eduardo Martin Arranz, Luis Menchen, Susanna Nikolaus, Anca Petrache, Cyriel Ponsioen, Sabino Riestra, Pilar Robledo, Cristina Rodriguez, Misheal Samer, Matthias Tischer, Joanna Wypych, Julien Baudon, Cristina Bezzio, Gilles Boschetti, Johan Burisch, Tom Creed, Maria Giulia Demarzo, Stefano Festa, Andrés Figueroa, Mette Julsgaard, Pablo Navarro, Pablo Perez‐Galindo, Cléa Rouillon, Emanuele Sablich, Joan Tosca, Mathias Vidon, Marine Vidon, René‐Louis Vitte, Anne Wampach, Vered Abitbol, Sebastian Shaji, Livia Biancone, Alessandro Armuzzi, Konstantinos Karmiris, Nikolaos Viazis, Eugeni Domenech, Javier P. Gisbert, Peter Bossuyt, Catherine Reenaers, Christian Maaser, Britta Siegmund, Ulf Helwig, Johan Burisch, Mette Julsgaard, Henit Yanai, Uri Kopylov, Glen Doherty, Fernando Magro, Tamás Molnar, Mark Löwenberg, Bas Oldenburg, Jonas Halfvarson, Ann‐Sofie Backman, Edyta Zagorowicz, Jarosław Kierkus, Cédric Baumann, Isabelle Clerc Urmes, Julien Kirchgesner, Mathieu Uzzan, Rachel Cooney, Kelly Chatten, Jimmy Limdi, Rimmer Peter, Iqbal Tariq, Marta Cossignani, Nikolaos Viazis, Fiorella Cañete, Tom Holvoet, Susanne Krasz, Petra Weimers, Idan Goren, Sandra Dias, Klaudia Farkas, Daniel Bergemalm, Edyta Zagorowicz, Aziza Abaza, Gal Abramovich, Ingrid Ackzell, Carol Adams, Catherine Addleton, Erika Alfambra, Alicia Algaba, Clare Allcock, Joanna Allison, Karine Amouriaux, Julie Anderson, Saskia Appelmans, Sophie Armand, Lisa Armstrong, Stacey Atkins, Masoumeh Attaran‐Bandarabadi, Yvonne Bailey, Florian Bär, Stephanie Bardot, Natasha Beck, Lillie Bennett, Jonathan Phil Bergfeld, Ramdane Berkane, Marion Blin, Hanne Boey, Louise Bowlas, Tracy Brear, Nicole Bretlander‐Peters, Ellen Brown, Johanna Brown, Elizabeth Buckingham, Katrien Buellens, Rhian Bull, Maura Burke, Julie Burton, Agness Bwalya, Karine Cabanas, Muriel Callaghan, Océane Camou, Debbie Campbell, Elvira Capoferro, Mandy Carnahan, Cornelia Carnio, Anne Carter, Concetta Casali Clack, Leïla Chedouba, Bessie Cipriano, Sophie Claeys, Elizabeth Clayton, Manon Closset, Dilek Coban, Sara Cococcia, Carolann Coe, Helen Cole, Emilie Collet, Kayleigh Collins, Isabelle Combes, Emma Connor, Kathryn Constantin, Susan Cooke, Nathanaëlle Cornet, Estelle Corrihons, Pilar Corsino, Rosie Cortaville, Marta Cossignani, Donna Cotterill, Amanda Cowton, Harriet Cox, Viktoria Cripps, Amanda Crowder, Tzufit Cukier, Amelia Daniel, Chris Dawe, Jose de Haan, Rosanna de la Croix, Evva Dejonckheere, Juan Delare Villanegro, Guillaume Delaval, Mariangela Delliponti, Emilie Detry, Melanie Dhanaratne, Sandra Dias, Laura Diez Galan, Marie Dodel, Emma Dooks, Joseph Du Cheyron, Linda Duane, Helene Dukwen, Jennifer Dulling Vulgo Cochran, Simona Dyer, Harvey Dymond, Charlotte Ekblad, Kerry Elliott, Ingrid Emmerson, Irène Eugene‐Jolchine, Lorna Fleming, Lorna Fleming, Eve Fletcher, Sarah Ford, Greg Forshaw, Angela Foulds, Caroline Francois, Nicole Fuge, Gal Gafni, Miri Ganon, Olga Garcia Nuñez, Laura Garcia Ramirez, Sophie Gelder, Raimonda Gettkowski, Daniela Gilardi, Paolo Giuffrida, Vincent Gobert, Jo Godden, Nuala Godwin, Kay Goulden, Sharon Graham, Charlotte Green, Marie Green, Aboubakar Gueye, Tuba Guler, Ida Gustavsson, Helena Hadjisavvas, Fiona Hammonds, Christina Hantzi, Marion Hauke, Julie Haydock, Julie Haydock, Orla Hayes, Lizette Helbo Nislev, Jessica Hochstodter, Ashleigh Hogg, Maureen Holland, Maartje Holsbergen, Linda Howard, Aviya Hoyda, Robert Hull, Jane Irish, Wendy Jackson, Wendy Janssen, Lesley Jeffrey, Lesley Jeffrey, Sofia Jourdan, Izabela Jutrowska, Chava Kaniel, Theofilos Karezos, Niamh Kelly, Jessica Kelly, Mary Kennedy, Una Kennedy, Joyce Kibaru, Gemma Kirkman, Janine Klaproth, Corinna Kneese, Andrea Koch, Kathleen Kokke, Martha Koppelow, Susanne Krasz, Sabine Krause, Sabine Krauspe, Petra Kwakkenbos, Nunzia Labarile, Hannah Lang, Marianne Lassailly, Martine Leconte, Linda Lepczynski, Emma Levell, Nina Levhar, Kerstin Lindhort, Jessica Lisle, Gabriele Lorenz, Ambra Lovati, Tracey Lowry, Margareta Lund, Suzanne Maansson, Videsheka Madapathage, Maelys Cheviakoff, Alison Magness, Orla Manley, Catherine Manyoni, Ingke Marg, Antonella Marra, Carole Martins, Arianna Massella, Aurore Mathias, Karin Menzel, Danielle Mervyn, Charlotte Minsart, Sally Mitchell, Kathleen Monks, Mélanie Montero, Alson Moore, Maren Moser, Alison Moss, Angela Mullen, Mª Francisca Murciano, Deanna Naylor, Ansgar Nehus, Anne Nicholson, Sarah Nöding, Sinead Nolan, Janet Nörenberg, Clare Northcott, Pauline Oates, Jim O’Connell, Alison O’Kelly, Noam Orbach‐Zingboim, Judit Orobitg, Charlene Otieno, Charlotte Owen, Sarah Patch, Maor Pauker, Renate Pauli, Harriet Pearson, Falgon Peggy, Séverine Petit, Christine Petrissans, Simona Piergallini, Lucy Pippard, Laura Pitt, Gabriella Pócsik, Yoann Poher, Chloé Pomes, Lucy Pritchard, Laura Puchades, Sheena Quaid, Aleem Rana, Aleem Rana, Dana Raynard, Mykla Reilly, Sonja Reinert, Manuela Reinknecht, Baerbel Renner, Rob Reynolds, Giulia Rizzuto, Matthew Robinson, Joke Robrechts, Eva Mª Rodriguez, Efrat Rosenblum, Tamlyn Russel, Ibiyemi Sadare, Noa Salama, Toos Schakel, Anja Schauer, Elisa Schiavoni, Caroline Shaw, Sarah Shelton, Virginie Sicart, Orla Smith, Théo Soude, Sophie Stephenson, Elaine Stephenson, Marjan Steppe, An Sterkx, Jo Stickley, Jo Stickley, Jo Stickley, Kathleen Sugrue, Natalia Swietec, Charlotte Tasiaux, Bhavneet Thamu, Susane Thomas, Ogwa Tobi, Kahina Touabi, Shifra Tovi, Julie Tregonning, Laura Turchini, Julia Unkhoff, Olesya Unruh, Nurcan Uzun, Frauke Van Aert, Sandrine Vanden Bergh, Louise Vandenbroucke, Laura Vansteenkiste, Shay Vardit, Valentin Vergriete, Elaine Walker, Eleanor Warner, Olivia Watchorn, Ekaterina Watson, Marie‐Claire Wauthier, Maria Weetman, Margaret Weston, Wiebke West‐Petroschka, Susann Wienecke, Kerstin Wierling, Miriam Wiestler, Rebecca Wilcox, Elva Wilhelmsen, Angharad Williams, Georgina Williamson, Deborah Wilson, Kate Wistance, Nicolas Wortmann, Subie Wurie, Karin Yadgar, Gail Young, Megan Young, Marie‐ Jo Bertin, Hasnae Bougrine, Marie Coisnon, Antoine Defrance, Kati Gutierrez, Amel Harouz, Laure Jerber, Aida Khlifi, Amina Kirati, Nasaladjine Liworo, Maude Logoltat, Charlotte Mailhat, Chancely M’Bayi, Yasmina Medane, Dalal Merkhoufa, Saouda Mohamed Elhad, Bertille Monthe, Fanny Moyon, Pascaline Rabiega, Jennifer Sekela, Charlotte Thilloy, Naima Hamamouche, Frederic Partisotti, Patrick Blandin, Hocine Mokhtari, Laure Coutard +906 morewiley +1 more sourceImplementation of OMOP and ConcePTION Common Data Models in CPRD GOLD: Risk of Bleeding and Cardiovascular Outcomes From Anticoagulant Use
Clinical Pharmacology &Therapeutics, EarlyView.The impact of the choice of common data model (CDM) approach on the study results in a real‐world evidence (RWE) study is unknown. We aimed to determine potential differences in the results of an RWE study when data were mapped to two different CDMs, ConcePTION and OMOP. With the same instance of CPRD GOLD, data were mapped to both CDMs. Using the same Nicholas B. Hunt, Patrick Souverein, Marloes Bazelier, Nicola Barclay, Antonella Delmestri, Miriam Sturkenboom, Daniel Prieto‐Alhambra, Helga Gardarsdottir, Olaf Klungel +8 morewiley +1 more sourceBoron deficiency responses in maize (Zea mays L.) roots
Journal of Plant Nutrition and Soil Science, EarlyView., 2023 Abstract Background
Boron (B) is an essential micronutrient for plants. Dicot plants respond to insufficient B supply by altering root architecture and root hair growth. How root systems of rather low‐B demanding monocot species such as maize (Zea mays L.) respond to B deficiency in terra has not been experimentally resolved, yet.Manuela Désirée Bienert, Astrid Junker, Michael Melzer, Thomas Altmann, Nicolaus von Wirén, Gerd Patrick Bienert +5 morewiley +1 more source
