Application of Physiologically Based Pharmacokinetic Modeling to Characterize the Effects of Age and Obesity on the Disposition of Levetiracetam in the Pediatric Population

Pediatric Trials Network (PTN) Steering Committee Members: Daniel K. Benjamin Jr, Kanecia Zimmerman, Phyllis Kennel, Cheryl Alderman, Zoe Sund, Kylie Opel, and Rose Beci, Duke Clinical Research Institute, Durham, NC; Chi Dang Hornik, Duke University Medical Center, Durham, NC; Gregory L. Kearns, Scottsdale, AZ; Matthew Laughon, University of North Carolina at Chapel Hill, Chapel Hill, NC; Ian M. Paul, Penn State College of Medicine, Hershey, PA; Janice Sullivan, University of Louisville, Louisville, KY; Kelly Wade, Children's Hospital of Philadelphia, Philadelphia, PA; Paula Delmore, Wichita Medical Research and Education Foundation, Wichita, KS; Leanne West, International Children’s Advocacy Network; Susan Abdel-Rahman; The Eunice Kennedy Shriver NICHD; Ravinder Anand, Elizabeth Payne, Lily Chen, Gina Simone, Kathleen O’Connor, Jennifer Cermak, and Lawrence Taylor, The Emmes Company, LLC (Data Coordinating Center). PTN Publications Committee: Thomas Green (Chair), Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL; Danny Benjamin; Perdita Taylor-Zapata; Kelly Wade; Greg Kearns; Ravinder Anand; Ian Paul; Julie Autmizguine; Edmund Capparelli; Kanecia Zimmerman; Rachel Greenberg; Cheryl Alderman; Terren Green. The assay measuring levetiracetam concentrations was performed at the PTN central laboratory (Frontage, LLC, Exton, PA, USA). The PTN AED01 Levetiracetam Study Team, PIs, and study coordinators (SCs) are as follows: Alfred I. DuPont Hospital for Children, Wilmington, DE: Marisa Meyer (PI), Ramany John (SC); Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago, IL: William Muller (PI), Ram Yogev (PI), Laura Fearn (SC); Coastal Children's Services, Wilmington, NC: Sasidharan Taravath (PI), Tiffony Blanks (SC), Arielle Lapid (SC); Duke University Medical Center, Durham, NC: Chi Hornik (PI), Melissa Harward (SC); Oregon Health and Science University, Portland, OR: Amira Al-Uzri (PI), Kira Clark (SC), Sarah Craven (SC), Kimberly Grzesek (SC); The Children's Hospital Colorado, Aurora, CO: Charuta Joshi (PI), Austin Drake (SC), Lauri Filar (SC), Jennifer Sargent (SC); University of Louisville Norton Childrens Hospital, Louisville, KY: Arpita Lakhotia (PI), Michael Oldham (PI), Julie Burmester (SC), Stephany Eubanks (SC), Terri Simeon (SC); University of North Carolina at Chapel Hill, Chapel Hill, NC: Yael Shiloh-Malawsky (PI), Christopher Anderson (SC), Mallory Jolly (SC), Shradhdha Joshi (SC), Norbert Odero (SC), Jennifer Taylor (SC); University of Texas Southwestern Medical Center Dallas, Dallas, TX: Susan Arnold (PI), Caryn Harper (SC), Erica Howard (SC), Maria Martinez (SC), Deanna Myer (SC), Angela Walker (SC). The PTN POP01 Levetiracetam Study Team, PIs, and SCs are as follows: Akron Children's Hospital, Akron, OH: Martha Blackford (PI), Michael Reed (PI), Amanda Hodge (SC), Tasha Capozzi (SC), Heather Anthony (SC); Alfred I. DuPont Hospital for Children, Wilmington, DE: Glenn Stryjewski (PI), Marisa Meyer (PI), Kimberly Klipner (SC), Ramany John (SC), Karen Kowal (SC); Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago, IL: Ram Yogev (PI), William Muller (PI), Benjamin Traisman (SC), Carol Nielsen (SC), Pam Sroka (SC), Laura Fearn (SC), Assaf Harofeh Medical Center: Matitiahu Berkovitch (PI), Elkana Kohn (SC); Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC: Catherine Litalien (PI), Julie Autmizguine (PI), Diane Desmarasis (SC), Christine Massicotte (SC), Mariana Dumitrascu (SC), Vincent Lague (SC); Childrens Hospital Colorado, Aurora, CO: Neil Goldenberg (PI), Peter Mourani (PI), Jendar Deschenes (SC), Domninic DiDomenico (SC), Megan Dix (SC), Gentle Halstenson (SC), Kathryn Malone (SC), Kimberly Ralston (SC), Alleluiah Rutebemberwa (SC), Yamila Sierra (SC), Matthew Steinbeiss (SC), Kevin Van (SC); Children's Hospital of Eastern Ontario, Ottawa, ON: Hugh McMillan (PI), Roger Zemek (PI), Thierry Lacaze (PI), Daniela Pohl (PI), Angie Tuttle (SC), Barbara Murchison (SC), Sara Ieradi (SC); Cincinnati Childrens Hospital, Cincinnati, OH: Stuart Goldstein (PI), Gary Bradley (SC), Stuart Goldstein (SC), Theresa Mottes (SC), Tara Terrell (SC), Patricia Arnold (SC), Bradley DePaoli (SC), Bradley Gerhardt (SC), Cassie Kirby (SC); Duke University Medical Center, Durham, NC: Kevin Watt (PI), Chi Hornik (PI), Grace Jefferson (SC), Nicole Baisden (SC), Heidi Tiedge (SC), Christie Milleson (SC), Samantha Wrenn (SC), Anne Baez (SC); Indiana University Health, Indianapolis, IN: Scott Denne (PI), Brenda Poindexter (PI), Gregory Sokol (PI), Brianne Kost (SC), Ashley Moore (SC), Mattel Childrens Hospital UCLA: Jaime Deville (PI), Kavita Shankar (SC), Elizabeth Lang (SC); The Hospital for Sick Children, Toronto, ON: Yaron Finkelstein (PI), Maggie Rumantir (SC); The Wolfson Childrens Hospital, Jacksonville, FL: Mobeen Rathore (PI), Kathleen Thoma (SC), Alexandrea Borges (SC); University Hospitals Case Medical Center, Cleveland, OH: Philip Toltzis (PI), David Speicher (PI), Eloise Lemon (SC), Brenna Vitou (SC), Eileen Goldblatt (SC), Ramon Adams (SC), Catherine Tasi (SC), Lisa Petersen (SC), Ashlee Parsons (SC); University of Arkansas for Medical Sciences, Little Rock, AK: Laura James (PI), Dawn Hansberry (SC), Michelle Hart (SC), Lee Howard (SC), D Ann Pierce (SC); University of Louisville-KCPCRU, Louisville, KY: Janice Sullivan (PI), Karrie Kernen (SC), Susan Poff (SC), Courtney Konow (SC), Kelli Brown (SC), Jen Comings (SC), Andrew Michael (SC), Jackie Perry (SC), Michelle Wiseheart (SC); University of North Carolina Hospital, Chapel Hill, NC: Matthew Laughon (PI), Janice Bernhardt (SC), Ashley Mariconti (SC), Jennifer Talbert (SC); University of Utah School of Medicine, Salt Lake City, UT: Michael Spigarelli (PI), Catherine Sherwin (PI), Fumiko Alger (SC), JoAnn Narus (SC), Rebbecca Perez (SC), Priscilla Rosen (SC), Yakub Salman (SC), Kaylynn Shakespear (SC), Joshua Shimizu (SC), Sharada Dixit (SC); Wesley Medical Center, Wichita, KS: Paula Delmore (PI and SC). For the AED01 protocol, the authors would like to acknowledge the following Duke Clinical Research Institute staff: Natasha Green, Barrie Harper, Jalila Guy, Emily Forgey, Rose Beci, Katherine Deland, Tedryl Bumpass, Tammy Day, Kim Cicio, and Adam Samson. For the POP01 protocol, the authors would like to acknowledge the following Duke Clinical Research Institute staff: Barrie Harper, Rose Beci, Kylie Opel, Tedryl Bumpass, Lori Banctel, Gary Gong, Tarsha Ince, Tammy Day, Adam Samson and Wendy Lavender. The authors would like to acknowledge Kim Kaneshige and Gina Simone from the Emmes Corporation for their involvement with the AED01 and POP01 protocols, respectively, and Terren Green for editorial support. Phoenix WinNonlin was generously provided to the authors by Certara through the Academic Center of Excellence Program.

留言 (0)

沒有登入
gif