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pro vyhledávání: '"and Daniela Drago"'
Publikováno v:
Molecular Therapy: Methods & Clinical Development, Vol 31, Iss , Pp 101125- (2023)
The recent increase in cell and gene therapies being developed has been coupled with a disproportionate increase in Food and Drug Administration (FDA)-mandated clinical holds. Aiming to better understand causes and secondary effects of these clinical
Externí odkaz:
https://doaj.org/article/4a1ef40c0380415c9f0f15824836295f
Publikováno v:
Molecular Therapy: Methods & Clinical Development, Vol 21, Iss , Pp 524-529 (2021)
The rapid expansion of the gene therapy pipeline in recent years offers significant potential to treat diseases with great unmet medical need. However, the unique nature of these therapies poses challenges to regulating them within traditional framew
Externí odkaz:
https://doaj.org/article/8dacb75294d34035838ec7670d14bd1c
Publikováno v:
BMC Medical Education, Vol 18, Iss 1, Pp 1-9 (2018)
Abstract Background Health professions’ education programs are undergoing enormous changes, including increasing use of online and intensive, or time reduced, courses. Although evidence is mounting for online and intensive course formats as separat
Externí odkaz:
https://doaj.org/article/86f3266ffe1b48c8820aca187f2e1f85
Publikováno v:
Mol Ther
Autor:
Paige L. McDonald, Kenneth J. Harwood, Joan T. Butler, Karen S. Schlumpf, Carson W. Eschmann, Daniela Drago
Publikováno v:
Medical Education Online, Vol 23, Iss 1 (2018)
Intensive courses (ICs), or accelerated courses, are gaining popularity in medical and health professions education, particularly as programs adopt e-learning models to negotiate challenges of flexibility, space, cost, and time. In 2014, the Departme
Externí odkaz:
https://doaj.org/article/1906428c09484c3aa5e6b887f0041356
Publikováno v:
Cell and Gene Therapy Insights. 6:877-885
Publikováno v:
Expert opinion on drug safety. 18(3)
Introduction Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, a
Publikováno v:
Clinical Research and Regulatory Affairs. 33:59-65
In today’s globalized drug development landscape, the need for regulatory professionals to be more seamlessly integrated into strategic decisions is evident. Whereas a few companies see the benefit of involving regulatory affairs professionals in s
Publikováno v:
BMC Medical Education
BMC Medical Education, Vol 18, Iss 1, Pp 1-9 (2018)
BMC Medical Education, Vol 18, Iss 1, Pp 1-9 (2018)
Background Health professions’ education programs are undergoing enormous changes, including increasing use of online and intensive, or time reduced, courses. Although evidence is mounting for online and intensive course formats as separate designs
Publikováno v:
Therapeutic innovationregulatory science. 50(3)
The growing belief that an effective regulatory function is vital to the successful development of medical products has spurred initiatives in regulatory education. To help prepare highly skilled professionals, some academic institutions have begun t