Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Debra L. Michaels"'
Publikováno v:
Therapeutic Innovation & Regulatory Science. 55:1193-1198
Interest in patient-centric initiatives to engage patients as partners in clinical research and inform drug development strategy, planning and execution has increased exponentially during the past decade. Adoption, use, organizational approach and in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ca0cab26fe999d4681f06537ec5a759d
https://doi.org/10.1007/s43441-021-00289-6
https://doi.org/10.1007/s43441-021-00289-6
Publikováno v:
Therapeutic innovationregulatory science. 55(6)
Interest in patient-centric initiatives to engage patients as partners in clinical research and inform drug development strategy, planning and execution has increased exponentially during the past decade. Adoption, use, organizational approach and in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::4a55e6401e577d9dfda2108ab0f5ca30
https://pubmed.ncbi.nlm.nih.gov/34283406
https://pubmed.ncbi.nlm.nih.gov/34283406
Publikováno v:
Clinical therapeutics. 41(8)
Purpose A growing number of biopharmaceutical companies have been implementing patient-centric initiatives (PCIs). The Drug Information Association (DIA) and the Tufts Center for the Study of Drug Development (CSDD) collaborated on a study to gather
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d93820ebc3d7b79d3cbd321459a8e8d5
https://pubmed.ncbi.nlm.nih.gov/31443914
https://pubmed.ncbi.nlm.nih.gov/31443914
Autor:
Rebecca Noel, Anne M. Wolka, F. Reed Johnson, Debra L. Michaels, Marilyn Metcalf, Meredith Smith, Tarek A. Hammad, Bennett Levitan
Publikováno v:
Therapeutic innovationregulatory science. 50(5)
Benefit-risk assessment is the foundation for decision making throughout the life cycle of medical products. Because patients are the beneficiaries of the efficacy of medical treatments and also bear their possible risks, their perspectives and judgm
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b39fc4adb50f56e06febd73f1b38fb5e
https://pubmed.ncbi.nlm.nih.gov/30231755
https://pubmed.ncbi.nlm.nih.gov/30231755
Autor:
Lode Dewulf, Martha R. Nolan, David B. Clemow, Debra L. Michaels, Andreas M. Kogelnik, Susan A. Cantrell
Publikováno v:
Therapeutic innovationregulatory science. 49(3)
To raise awareness and promote dialogue leading to action, this article provides proceedings on ethical and legal considerations associated with medicine use during pregnancy discussed during the 2014 DIA Medicines and Pregnancy Forum. A key focus of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b25d7e599391bb4fb5fac2df0e2ad11
https://pubmed.ncbi.nlm.nih.gov/30222404
https://pubmed.ncbi.nlm.nih.gov/30222404
Publikováno v:
Therapeutic innovationregulatory science. 54(1)
Recently, drug development companies have sought out patient feedback to improve overall drug development. However, characterization of the overall impact and return on engaging with patients have not been determined. The Drug Information Association
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::202dd56908f7e895df364b608b46231c
https://pubmed.ncbi.nlm.nih.gov/32008233
https://pubmed.ncbi.nlm.nih.gov/32008233
Autor:
Debra L. Michaels, David B. Clemow, Martha R. Nolan, Susan A. Cantrell, Lode Dewulf, J. Stephen Mikita, Andreas M. Kogelnik, Gideon Koren
Publikováno v:
Therapeutic Innovation & Regulatory Science. 48:145-154
The objective of this paper is to communicate a proposed framework for addressing research limitations and communication barriers that contribute to a lack of data for making clinical treatment decisions about medication use in pregnancy. To address
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fe8016c01350e1964b8b37d71983069b
https://doi.org/10.1177/2168479014522469
https://doi.org/10.1177/2168479014522469
Autor:
Gideon Koren, Lode Dewulf, Martha R. Nolan, Andreas M. Kogelnik, David B. Clemow, Susan A. Cantrell, Debra L. Michaels, J. Stephen Mikita
Publikováno v:
Therapeutic Innovation & Regulatory Science. 48:134-144
The objective of this paper is to explore the strengths, weaknesses, gaps, and needs in research on medication use in pregnancy, where opportunities have been bypassed to develop standards and collaborations for collecting data to better understand h
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::263740276874b3d00c62da55614d525c
https://doi.org/10.1177/2168479014523006
https://doi.org/10.1177/2168479014523006