Literature DB >> 36103087

Accelerating Pediatric Drug Development: A 2022 Special Issue of Therapeutic Innovation & Regulatory Science.

Susan McCune1, Ronald J Portman2.   

Abstract

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Year:  2022        PMID： 36103087     DOI： 10.1007/s43441-022-00398-w

Source DB:  PubMed          Journal:  Ther Innov Regul Sci        ISSN： 2168-4790            Impact factor:   1.337


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  11 in total

Review 1.  Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies.

Authors:  Rima Izem; Joan Buenconsejo; Ruthanna Davi; Jingyu Julia Luan; LaRee Tracy; Margaret Gamalo
Journal:  Ther Innov Regul Sci       Date:  2022-06-08       Impact factor: 1.337

Review 2.  Digital Health Technologies in Pediatric Trials.

Authors:  Leonard Sacks; Elizabeth Kunkoski; Marianne Noone
Journal:  Ther Innov Regul Sci       Date:  2022-03-27       Impact factor: 1.337

Review 3.  Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of Efficacy.

Authors:  Allison Dunn; Dawoon Jung; Lisa L Bollinger; Michael Krams; Brian P Smith; Jogarao V S Gobburu
Journal:  Ther Innov Regul Sci       Date:  2022-04-26       Impact factor: 1.337

Review 4.  Health Equity in Pediatric Drug Development: Translating Aspiration into Operation.

Authors:  Morenike Oluwatoyin Folayan; Magda Conway; Carolyn Russo; Nilza Diniz; Lungile P Jafta; Nadia A Sam-Agudu; Sarah Bernays; Victor M Santana; Carla Epps; Mark A Turner
Journal:  Ther Innov Regul Sci       Date:  2022-05-20       Impact factor: 1.337

Review 5.  Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned.

Authors:  J Preston; B Nafria; A Ohmer; S Gaillard; P Dicks; L West; M A Turner
Journal:  Ther Innov Regul Sci       Date:  2022-02-19       Impact factor: 1.337

Review 6.  Improving Development of Drug Treatments for Pregnant Women and the Fetus.

Authors:  Anna L David; Homa Ahmadzia; Richard Ashcroft; Christina Bucci-Rechtweg; Rebecca N Spencer; Steve Thornton
Journal:  Ther Innov Regul Sci       Date:  2022-07-25       Impact factor: 1.337

Review 7.  Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children.

Authors:  Rachel G Greenberg; Susan McCune; Sabah Attar; Collin Hovinga; Breanne Stewart; Thierry Lacaze-Masmonteil
Journal:  Ther Innov Regul Sci       Date:  2022-09-09       Impact factor: 1.337

8.  A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population.

Authors:  Manfred Wargenau; Sibylle Reidemeister; Ingrid Klingmann; Viviane Klingmann
Journal:  Ther Innov Regul Sci       Date:  2022-04-26       Impact factor: 1.337

Review 9.  The Role of Master Protocols in Pediatric Drug Development.

Authors:  Robert M Nelson; Laurie S Conklin; Wendy J Komocsar; Fei Chen; Forrest Williamson; Wallace V Crandall
Journal:  Ther Innov Regul Sci       Date:  2022-09-01       Impact factor: 1.337

Review 10.  Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design.

Authors:  Julian Quodbach; Malte Bogdahn; Jörg Breitkreutz; Rebecca Chamberlain; Karin Eggenreich; Alessandro Giuseppe Elia; Nadine Gottschalk; Gesine Gunkel-Grabole; Lena Hoffmann; Dnyaneshwar Kapote; Thomas Kipping; Stefan Klinken; Fabian Loose; Tristan Marquetant; Hellen Windolf; Simon Geißler; Tilmann Spitz
Journal:  Ther Innov Regul Sci       Date:  2021-11-26       Impact factor: 1.337
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