Zobrazeno 1 - 9
of 9
pro vyhledávání: '"Janelle M, Burnham"'
Autor:
Dionna J Green, Susan McCune, Amber Ray, Gilbert J. Burckart, Janelle M. Burnham, Shiwei Fang, Lynne Yao
Publikováno v:
Therapeutic Innovation & Regulatory Science. 55:622-630
Corticosteroid use has been associated with hypothalamic–pituitary–adrenal (HPA) axis suppression which can predispose the pediatric patient to multiple immune- and growth-related adverse effects. The objectives of this review were to identify th
Autor:
Kyunghun Park, Lynne Yao, Gilbert J. Burckart, Susan McCune, Janelle M. Burnham, John N. van den Anker, Dionna J Green, Shogo John Miyagi, Irin Tanaudommongkon, Johanna Wu
Publikováno v:
Clinical Pharmacology & Therapeutics. 108:1018-1025
Despite legislation incentivizing and requiring drug companies to conduct pediatric clinical trials, there still is a 9-year delay in drug approval for pediatric labeling after the initial adult drug approval. The aim of this study was to review the
Autor:
Janelle M, Burnham, Dionna J, Green, Amber, Ray, Shiwei, Fang, Lynne, Yao, Susan K, McCune, Gilbert J, Burckart
Publikováno v:
Therapeutic innovationregulatory science. 55(3)
Corticosteroid use has been associated with hypothalamic-pituitary-adrenal (HPA) axis suppression which can predispose the pediatric patient to multiple immune- and growth-related adverse effects. The objectives of this review were to identify the pe
Publikováno v:
Drug Discovery and Development ISBN: 9781315113470
Drug Discovery and Development
Drug Discovery and Development
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2cabd7b7fbb86d4427180c62b5d47fc6
https://doi.org/10.1201/9781315113470-31
https://doi.org/10.1201/9781315113470-31
Autor:
Paul Schuette, Gilbert J. Burckart, Xiaomei I Liu, Dionna J. Green, Joseph C. Y. Chen, Susan McCune, John N. van den Anker, Janelle M. Burnham, Lynne Yao, Brian M Maas
Publikováno v:
The Journal of Clinical Pharmacology. 58:885-890
The selection of appropriate endpoints in pediatric drug development trials is a critical aspect of trial design. Given the high pediatric trial failure rate, selecting optimal trial design elements, such as the primary efficacy endpoint, is essentia
Autor:
Dionna J. Green, Robert N. Schuck, Michael Pacanowski, Susan McCune, Issam Zineh, Janelle M. Burnham, Xiaomei I. Liu, Tianyi Hua, Lynne Yao, Gilbert J. Burckart
Publikováno v:
Clinical Pharmacology & Therapeutics. 104:983-988
Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. W
Autor:
Susan McCune, Haihao Sun, Gilbert J. Burckart, John N. van den Anker, Dionna J. Green, Janelle M. Burnham, Lynne Yao, Xiaomei I Liu, Jean Temeck
Publikováno v:
Clinical Pharmacology & Therapeutics. 105:555-557
The 21(st) Century Cures Act was passed in December, 2016, and included a number of provisions to facilitate drug approval. Considerable discussion was generated related to some aspects of the Act, especially to the use of surrogate endpoints (SEs) a
Autor:
Beatrice Chiang, Janelle M. Burnham, Kelley Lu, Gilbert J. Burckart, Perry Wu, André Dallmann, Mark Sheng, Dionna J Green, Xiaomei I Liu, Yow-Ming Wang, John N. van den Anker
Publikováno v:
Journal of Clinical Pharmacology
The experience with the use of monoclonal antibodies and Fc‐fusion proteins (mAb/Fc) in the pediatric population is limited. The objective of this study is to review those factors impacting the clinical efficacy and product safety of mAb/Fc product
Autor:
Julie La, Xiaomei I Liu, Shiew-Mei Huang, Janelle M. Burnham, John N. van den Anker, Natella Rakhmanina, Gilbert J. Burckart, Paul Schuette, Adelaide S. Robb, Dionna J Green
Publikováno v:
The Journal of Pediatrics. 208:236-242.e3
Objective To examine the differences in the adverse drug reaction (ADR) profile of antipsychotic and antidepressant agents between pediatric and adult patients in studies submitted to the Food and Drug Administration (FDA) during the drug development