Clinical data required for the approval of pediatric pharmaceuticals in Japan by Hisamitsu Haigo, Kenji Matsuda, Mayumi Shikano

Subjects: “…Pediatric…”
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Primary pediatric stroke center in the multidisciplinary pediatric hospital. New reality in pediatrics by E. E. Petryaykina, I. I. O. Shcherderkina

“…The increase in the number of diagnosed strokes in children, significant distinctive features and complexity of diagnosis, treatment and prevention of cerebrovascular diseases in children compared with adults, the impossibility of direct extrapolation of therapeutic recommendations from adult practice to pediatrics required the creation of specialized primary centers of pediatric stroke in Russia. …”
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Pediatric Stroke: A Review by Daniel S. Tsze, Jonathan H. Valente

“…Although most recommendations for management are extrapolated from adult populations, they still remain useful, in conjunction with pediatric-specific considerations.…”
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The paradigm of anthropocentrism in contemporary pediatric surgery by V.О. Dubinina, І.V. Ksonz, S.М. Bilash, L.V. Abyzova, О.S. Bilanov

“…The methodology of the study was determined by the cultural approach based on the use of philosophical hermeneutics (interpretation of texts). The method of extrapolation allowed the use of philosophical heritage to analyze contemporary deontological issues. …”
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Clinical Trials in Pediatrics and Neonatology: Reasons for Ups and Downs by A. A. Mosikian, A. O. Tomasheva, T. L. Galankin, A. S. Kolbin

“…Other reasons for limited predictability are as follows: adult data extrapolation constraint due to children’s anatomic and physiological features, the lack of clinical trial subjects resulting in inability to select an optimal dose by its escalation, the absence of consensus on the ethical aspect of pediatric clinical trials, the etiopathogenetic difference of some diseases and conditions depending on subject’s age, and prevalence of placebo-effect in children. …”
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Antivirals in COVID-19: A Focus on Pediatric Cardiac Patients by Dalia Safi, Farah Khouri, Rana Zareef, Mariam Arabi

“…Furthermore, there is a paucity in the literature regarding the use of antivirals in the pediatric population infected with COVID-19, with their use being extrapolated from the results of studies done on adult patients. …”
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Active Epidemiological Surveillance: the Key for Effective Infection Prevention in Pediatric Surgery by A. A. Malashenko, B. I. Aslanov, V. V. Nechaev

“…Approaches  to the prevention of surgical site infections (SSI) in pediatric surgery is an extrapolation of data obtained mainly from studies in the adult surgical patients. …”
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The Use of Biotechnological Drugs in Pediatrics on the Example of Monoclonal Antibodies: Clinical Pharmacology View by Alexey S. Kolbin, Liudmila I. Yemelyanova

“…It is important to consider the growth and development as “moving targets" in pediatrics regardless the principle of monoclonal antibodies dosage in children. …”
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Prediction of Monoclonal Antibody Pharmacokinetics in Pediatric Populations Using PBPK Modeling and Simulation by Chiara Zunino, Virginie Gualano, Haiying Zhou, Viera Lukacova, Maxime Le Merdy

“…<b>Background</b>: Accurately determining pediatric dosing is essential prior to initiating clinical trials or administering medications in routine clinical settings. …”
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Clinical Profile of Pediatric Solid Tumors: Experience From a Tertiary Care Center in Ethiopia by Mamude Dinkiye, Deme Abdissa, Tadele Hailu, Aziza T. Shad, Yoram Unguru

“…Paul's Hospital Millennium Medical College hemato‐oncology unit with a pediatric solid tumor. Data from patient charts was extrapolated and analyzed using SPSS version 29. …”
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Management of Syndesmotic Ankle Injuries: Results of a Survey of Pediatric Orthopaedic Society of North America Members by Caroline E. Williams, MD, Blair Stewig, BS, Sang Won Lee, MS, Danielle Cook, MA, Benjamin J. Shore, MD, MPH, FRCSC, Collin J. May, MD, MPH

“…Conclusions: Our data shows that the shift over time from screw to suture-button implant fixation for pediatric and adolescent syndesmotic ankle injuries is largely due to interest in avoiding implant removal and extrapolation from superior outcomes seen with suture-button use in adults. …”
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Landscape of Post-Marketing Requirements Under the Pediatric Research Equity Act for Antibiotics from 2009–2024 by Daniel Selig, Funmi Aminu, Sue Cammarata, Ting Chen, Lauren Dolak, Stephen Duprez, Stephanie Ecker, Lisa Gault, Sandra George, Margaret Harkins, Clayton Litchmore, Michael Serenko, William Waverczak, Doug Girgenti

“…To improve PMR study completion, smaller companies require continued financial support and innovation in study design. For pediatric antibiotic development, the FDA accepts the extrapolation of efficacy from well-conducted randomized adult trials (i.e., pharmacokinetics (PK) and the safety approach). …”
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Cost-effectiveness analysis of routine pediatric vaccination of 15-valent pneumococcal conjugate vaccine in South Korea by Young June Choe, Yunjin Jeon, Jihyun Park, Hyesun Kim, Gyongseon Yang, Salini Mohanty, Lefteris Floros, Min Huang, Nitika Chhabra, Shalini Kumari, Jasmeet Singh, Isaya Sukarom

“…The effectiveness of PCV15 was extrapolated from PCV13 data. Herd immunity effects were applied. …”
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An overview of proactive monitoring and management of respiratory issues in ataxia-telangiectasia in a specialist and shared care pediatric clinic by Jayesh Mahendra Bhatt, Andrew Bush

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New medicines for childhood-onset systemic lupus erythematosus: an EU perspective on paediatric drug development by Roberto De Lisa, Fernando de Andres-Trelles, Fernando de Andres-Trelles, Ralph Bax, Sara Galluzzo, Sara Galluzzo, Brian Alward, Brian Alward, Andrew Thomson, Dominik Karres, Hermine I. Brunner, Nicolino Ruperto, Nicolino Ruperto, Gunter F. Egger

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Prediction of Pharmacokinetics for CYP3A4-Metabolized Drugs in Pediatrics and Geriatrics Using Dynamic Age-Dependent Physiologically Based Pharmacokinetic Models by Jing Han, Zexin Zhang, Xiaodong Liu, Hanyu Yang, Li Liu

“…Following validation using clinic observations in adult populations, the developed PBPK models were extrapolated to other age populations, such as pediatrics and geriatrics, via replacing their physiological parameters and pharmacokinetic parameters, such as organ volume, organ blood flow, clearance, f_u,b and K_t:p. …”
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The importance of patient engagement when promoting age-inclusive research by Lydia E. Roberts, James O. Burton, Manish D. Sinha, Jonathan Barratt, Louise Oni

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Stroke in adolescent patient requiring mechanical thrombectomy: A case report by Alyssa M. Gill, Carina Grain, Christine Dharshika, Todd Chassee

“…Treatment for pediatric stroke is also much less researched and often extrapolated from adults. …”
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Eptifibatide bolus dose postductal stenting intervention: A single-center experience by Rishika Mehta, Amitabha Chattopadhyay, Aritra Mukherji, Sanjiban Ghosh, Jayita Nandy Das, Pushpanjali Gupta

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Neonatal solid tumors by Aravindan Chandrasekaran

“…Background: Neonatal tumors are different from tumors of the older children and knowledge gained from treating older children can not be extrapolated to neonates. Neonates have immature physiology and their haematopoietic and immune systems are not fully developed and the response to therapy is unpredictable. …”
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