Zobrazeno 1 - 10
of 26
pro vyhledávání: '"Hari Cheryl, Sachs"'
Autor:
Sherry Zhao, Mary Gockenbach, Manuela Grimstein, Hari Cheryl Sachs, Mark Mirochnick, Kimberly Struble, Yodit Belew, Jian Wang, Edmund V. Capparelli, Brookie M. Best, Tamara Johnson, Jeremiah D. Momper, Anil R. Maharaj
Publikováno v:
Frontiers in Pediatrics, Vol 9 (2021)
Background: Alterations in plasma protein concentrations in pregnant and postpartum individuals can influence antiretroviral (ARV) pharmacokinetics. Physiologically-based pharmacokinetic (PBPK) models can serve to inform drug dosing decisions in unde
Externí odkaz:
https://doaj.org/article/255de7edd5bf4599bab6e29d0798c310
Autor:
Arzu Selen, Hao Zhu, Elimika Pfuma Fletcher, Shailly Mehrotra, Jack Cook, S.Y. Amy Cheung, Karen C. Thompson, Yuet Mei Khong, Lea Cunningham, Hari Cheryl Sachs, Jing Liu, Akhtar Siddiqui, Jian Wang, Vivek S. Purohit, Justin L. Hay
Publikováno v:
European Journal of Pharmaceutics and Biopharmaceutics. 164:66-74
A pediatric formulation workshop entitled "Pediatric Formulations: Challenges of Today and Strategies for Tomorrow" was held to advance pediatric drug product development efforts in both pre-competitive and competitive environments. The workshop had
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b35834ce01691d40afd4b150d1776ca
https://doi.org/10.1016/j.ejpb.2021.04.010
https://doi.org/10.1016/j.ejpb.2021.04.010
Autor:
Tamara Johnson, Brookie M. Best, Yodit Belew, Anil R. Maharaj, Manuela Grimstein, Hari Cheryl Sachs, Edmund V. Capparelli, Kimberly A Struble, Jeremiah D. Momper, Jian Wang, Mary Gockenbach, Mark Mirochnick, Sherry Zhao
Publikováno v:
Frontiers in Pediatrics
Frontiers in Pediatrics, Vol 9 (2021)
Frontiers in Pediatrics, Vol 9 (2021)
Background: Alterations in plasma protein concentrations in pregnant and postpartum individuals can influence antiretroviral (ARV) pharmacokinetics. Physiologically-based pharmacokinetic (PBPK) models can serve to inform drug dosing decisions in unde
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ff4dfb6d4198238b07bb5a78186d63a7
Autor:
Donna Griebel, Insook Kim, Robert M. Nelson, Jeremiah D. Momper, M. Tobias Heinrichs, Issam Zineh, Yeruk Mulugeta, Nitin Mehrotra, Shaun Kumar, Gregory H. Reaman, Vikram Sinha, Hari Cheryl Sachs, Narayana Garimella, Gilbert J. Burckart, Lynne Yao, Kevin Krudys, Andrew E. Mulberg
Publikováno v:
The Journal of Clinical Pharmacology. 60:775-784
Chemotherapy-induced nausea and vomiting (CINV) is a common treatment-related adverse event that negatively impacts the quality of life of cancer patients. During pediatric drug development, extrapolation of efficacy from adult to pediatric populatio
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ecc62c7baa425edbca6a89cf6b56d5f
https://doi.org/10.1002/jcph.1577
https://doi.org/10.1002/jcph.1577
Autor:
Vikram Sinha, Lynne Yao, Anne Zajicek, Hari Cheryl Sachs, Yeruk Mulugeta, Susan McCune, Jeffrey S. Barrett
Publikováno v:
Pediatric Clinics of North America. 64:1185-1196
Pediatric legislation has generated information about the efficacy, safety, and dosing of more than 600 products in children. Extrapolation of adult efficacy data has been an integral part of pediatric drug development. Advances in our understanding
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c8a6f5bf268d4c6b96e0ae8b0688dfc2
https://doi.org/10.1016/j.pcl.2017.08.015
https://doi.org/10.1016/j.pcl.2017.08.015
Autor:
Jian Wang, Leyla Sahin, Robert M. Nelson, D Johnson-Lyles, Teresa Baker, Thomas W. Hale, Tamara Johnson, Lynne Yao, J Sauberan, Philip O. Anderson, C Nguyen, Gilbert J. Burckart, S Ito, Zhaoxia Ren, Tassinari, Christina Bucci-Rechtweg, Hari Cheryl Sachs, D Pica-Branco, Christina D. Chambers, Anne Zajicek
Publikováno v:
Clinical pharmacology and therapeutics, vol 101, iss 6
This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::334b8f7d89b168d4b1ce14d89ae658c3
https://doi.org/10.1002/cpt.676
https://doi.org/10.1002/cpt.676
Autor:
Jian Wang, John J. Alexander, Lynne Yao, Yaning Wang, Hari Cheryl Sachs, Mona Khurana, Yifei Zhang, Hao Zhu, Gilbert J. Burckart
Publikováno v:
Clinical pharmacology and therapeutics. 108(1)
Exposure-response (E-R) modeling provides a quantitative tool to leverage adult data to support pediatric trial design and drug approval. The pediatric E-R studies submitted to US Food and Drug Administration (FDA) between 2007 and 2018 were surveyed
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::20f35a74bdaab76f95343e5db8c72434
https://pubmed.ncbi.nlm.nih.gov/32030741
https://pubmed.ncbi.nlm.nih.gov/32030741
Autor:
Yeruk Lily, Mulugeta, Anne, Zajicek, Jeff, Barrett, Hari Cheryl, Sachs, Susan, McCune, Vikram, Sinha, Lynne, Yao
Publikováno v:
Pediatric clinics of North America. 64(6)
Pediatric legislation has generated information about the efficacy, safety, and dosing of more than 600 products in children. Extrapolation of adult efficacy data has been an integral part of pediatric drug development. Advances in our understanding
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::927f56603e17de42b0489b2616d1f0ca
https://pubmed.ncbi.nlm.nih.gov/29173779
https://pubmed.ncbi.nlm.nih.gov/29173779
Publikováno v:
Pediatrics. 132:e796-e809
Many mothers are inappropriately advised to discontinue breastfeeding or avoid taking essential medications because of fears of adverse effects on their infants. This cautious approach may be unnecessary in many cases, because only a small proportion
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4933f8eb3773da66d824518a7eb7bd0f
https://doi.org/10.1542/peds.2013-1985
https://doi.org/10.1542/peds.2013-1985
Autor:
Lynne Yao, Hari Cheryl Sachs, Jeffrey S. Barrett, Gibert J. Burckart, Jane P. F. Bai, Bernd Meibohm
Publikováno v:
The AAPS Journal. 15:447-454
There are similar challenges in developing a product designed to treat patients with a rare disease and drugs to treat critically ill neonates and infants. Part of the challenge in developing such products as well as identifying the optimal dosing re
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::349ce323b52fa5954f8c6c13c0dfcce0
https://doi.org/10.1208/s12248-013-9452-z
https://doi.org/10.1208/s12248-013-9452-z