Zobrazeno 1 - 5
of 5
pro vyhledávání: '"Jean Mulinde"'
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
https://doi.org/10.47912/jscdm.216
Autor:
Phillip D. Kronstein, Jean Mulinde, Ni A. Khin, Seongeun-Julia Cho, Arindam Dasgupta, Cheryl Grandinetti, Gail Francis, Kassa Ayalew, Stephen Vinter, Jason Wakelin-Smith, Rachel Skeete, Bei Yu, Andrew Fisher, Paula Walker, Mandy Budwal-Jagait, Cynthia Kleppinger, Jennifer Martin, Michael McGuinness, Hayley Dixey
Publikováno v:
Clinical Pharmacology & Therapeutics. 112:31-43
With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::745066f63e6896fb319ecf5978f3d83a
https://doi.org/10.1002/cpt.2386
https://doi.org/10.1002/cpt.2386
Autor:
Bei Yu, Stephen Vinter, Phillip D. Kronstein, Rachel Skeete, Jean Mulinde, Cheryl Grandinetti, Arindam Dasgupta, Ruben C. Ayala, Seongeun‐Julia Cho, Ni A. Khin, Andrew Fisher, Gail Francis, Kassa Ayalew, Cynthia Kleppinger, Charles Bonapace
Publikováno v:
Clinical Pharmacology & Therapeutics. 108:949-963
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in cli
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fa102910e1afefdd1ed1b366114f3c46
https://doi.org/10.1002/cpt.1794
https://doi.org/10.1002/cpt.1794
Autor:
Pamela Tenaerts, Mark Behm, Martin J Landray, Coleen Glessner, Ann Meeker-O’Connell, Jean Mulinde, Fergus Sweeney, Nancy Roach
Publikováno v:
Clinical Trials (London, England)
Background: Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliab
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a24df97a4a60c32b2629c1297d725a22
https://pubmed.ncbi.nlm.nih.gov/27098014
https://pubmed.ncbi.nlm.nih.gov/27098014
Autor:
Manjari Joshi, Jean Mulinde
Publikováno v:
Journal of Antimicrobial Chemotherapy. 41:51-55
In the neutropenic host, the impaired inflammatory response diminishes the signs and symptoms of pulmonary infection, making diagnosis difficult. A practical approach to diagnosis and treatment in this population is to assess the radiographic appeara
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::108fb39b8d8ee14cdf98e7fb2e44bafb
https://doi.org/10.1093/jac/41.suppl_4.51
https://doi.org/10.1093/jac/41.suppl_4.51