Výsledky vyhledávání - "Jenn Sellers"

The United States Food and Drug Administration’s Innovative Alternative Tools to Evaluate Good Clinical Practice During the COVID-19 Public Health Emergency

Autor: Kassa Ayalew, Jenn Sellers, Phillip D. Kronstein, Laurie Muldowney, Emily Gebbia, Jean Mulinde, David Burrow

Publikováno v: Journal of the Society for Clinical Data Management. 2

The COVID-19 public health emergency limited the U.S. Food and Drug Administration’s ability to conduct on-site good clinical practice (GCP) inspections. Alternative tools have been used by the FDA during the pandemic to evaluate the reliability an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::1f2257f79fc15272f4a21cf9e4e18264
https://doi.org/10.47912/jscdm.216

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Comparison of Good Clinical Practice Inspection Processes for Marketing Applications between the United States Food and Drug Administration and the European Medicines Agency

Autor: Kassa Ayalew, Yang-Min Ning, Michelle J. Foringer, Susan Leibenhaut, Jenn Sellers, Bei Yu, Phillip D. Kronstein, Agata Higgerson, Camelia Mihaescu, Miguel Rodriguez, LaKisha Williams, Ni A. Khin

Background The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::57d6a76c14b31a947cc06ce510955afe
https://doi.org/10.21203/rs.3.rs-1667001/v1

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Comparison of Good Clinical Practice Inspection Process for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency

Autor: Kassa Ayalew, Yang-Min Ning, Michelle Foringer, Susan Leibenhaut, Jenn Sellers, Bei Yu, Phillip Kronstein, Agata Higgerson, Camelia Mihaescu, Miguel Rodriguez, LaKisha Williams, Ni Khin

Publikováno v: SSRN Electronic Journal.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::6815fdc978e5bc9e0bb9d7ce02a77538
https://doi.org/10.2139/ssrn.4066504

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Protein stability and in vivo concentration of missense mutations in phenylalanine hydroxylase

Autor: Jenn Sellers, Zhen Shi, John Moult

Publikováno v: Proteins: Structure, Function, and Bioinformatics. 80:61-70

A previous computational analysis of missense mutations linked to monogenic disease found a high proportion of missense mutations affect protein stability, rather than other aspects of protein structure and function. The purpose of the present study

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::349c80dfdd04697d1315ebdf5da28067
https://doi.org/10.1002/prot.23159

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