Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Brenda Gaydos"'
Autor:
Byron J. Hoogwerf, Haoda Fu, Elena Moscarelli, Robert J. Heine, David H. Manner, Brenda Gaydos
Publikováno v:
Diabetes Care. 39:S219-S227
The U.S. Food and Drug Administration (FDA) issued guidance on requirements to assess cardiovascular disease (CVD) risk with drugs being developed for approval for clinical use. The guidance was triggered by a meta-analysis published by Nissen and Wo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e576b0de438f059f04d132593f9fb245
https://doi.org/10.2337/dcs15-3025
https://doi.org/10.2337/dcs15-3025
Autor:
Boaz Hirshberg, Boaz Mendzelevski, Christophe Arbet-Engels, Deborah R. Shapiro, J. Rick Turner, Murray Stewart, Stefan Hantel, Brenda Gaydos, Thomas G. Todaro, Joerg Koglin, Cyrus R. Mehta, Philip T. Sager, Mary Jane Geiger
Publikováno v:
Therapeutic innovationregulatory science. 49(1)
In December 2008, the US Food and Drug Administration (FDA) issued a guidance for industry requiring sponsors to demonstrate that a new antidiabetic therapy being developed to treat type 2 diabetes does not increase cardiovascular (CV) risk to an una
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5f5771451500da6234c321f9dbeb79a0
https://pubmed.ncbi.nlm.nih.gov/30222452
https://pubmed.ncbi.nlm.nih.gov/30222452
Publikováno v:
Clinical Investigation. 2:235-240
Adaptive clinical trials attract great attention from academia, industry and regulatory authorities. Both the European Medicines Agency and the US FDA have clarified their positions in recently issued (final or draft) guidance documents. With this ba
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b384d021fa1d556d2f23890ba4ac7462
https://doi.org/10.4155/cli.12.5
https://doi.org/10.4155/cli.12.5
Publikováno v:
CHANCE. 27:31-33
Many scientists are drawn to statistics and biostatistics by their passion to make a difference using their skills in mathematics to tackle applied problems. We discuss a variety of aspects of work...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2d7445dffa94756cc613a4449b8ddb29
https://doi.org/10.1080/09332480.2014.988955
https://doi.org/10.1080/09332480.2014.988955
Autor:
Keaven M. Anderson, Vladimir Dragalin, Michael Krams, Christy Chuang-Stein, Brenda Gaydos, Paul Gallo, José Pinheiro
Publikováno v:
Journal of Biopharmaceutical Statistics. 20:1115-1124
The US Food and Drug Administration has recently released a draft guidance document on adaptive clinical trials. We comment on the document from the particular perspective of the authors as members of a PhRMA working group on this topic, which has in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::030cc79032155b3239037d9e02c6e8cd
https://doi.org/10.1080/10543406.2010.514452
https://doi.org/10.1080/10543406.2010.514452
Publikováno v:
Clinical Trials. 7:167-173
Background This review discusses barriers to implementing adaptive designs in a pharmaceutical R&D environment and provides recommendations on how to overcome challenges. A summary of findings from a survey conducted through PhRMA’s working group o
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b56980befc5a39605add3edc5a93e1f
https://doi.org/10.1177/1740774510361542
https://doi.org/10.1177/1740774510361542
Autor:
Christy Chuang-Stein, Roger J. Lewis, Parvin Fardipour, Michael Krams, Keaven M. Anderson, Donald A. Berry, Yili Pritchett, Nancy Burnham, Brenda Gaydos, Jennifer Dudinak, Paul Gallo, José Pinheiro, Sam Givens, Jeff Maca
Publikováno v:
Drug Information Journal. 43:539-556
This article is a summary of good adaptive practices for the planning and implementation of adaptive designs compiled from experiences gained in the pharmaceutical industry. The target audience is anyone involved in the planning and execution of clin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::69b624f1f4cb52d6627de9ec4b1a8ea8
https://doi.org/10.1177/009286150904300503
https://doi.org/10.1177/009286150904300503
Autor:
Frank Bretz, Christy Chuang-Stein, Alun Bedding, Inna Perevozskaya, Michael Krams, Qing Liu, Brenda Gaydos, José Pinheiro, Paul Gallo, Donald A. Berry
Publikováno v:
Drug Information Journal. 40:451-461
Insufficient exploration of the dose-response is a shortcoming of clinical drug development, and failure to characterize dosing early is often cited as a key contributor to the high late-stage attrition rate currently faced by the industry. Adaptive
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::cd082f8f91dfb16d8436fe3c279fb1fc
https://doi.org/10.1177/216847900604000411
https://doi.org/10.1177/216847900604000411
Autor:
Oranee Tangphao-Daniels, David A. Kareken, Richard C. Mohs, Leigh J. Beglinger, Brenda Gaydos, Eric Siemers
Publikováno v:
Journal of Psychopharmacology. 18:102-108
Participants in early Phase I clinical trials for drugs designed to enhance cognition are typically healthy volunteers. If improvement can be detected with a battery of cognitive tests in healthy volunteers, such a battery could be a pharmacodynamic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::366eecbc95802498ca7b063941e80a9f
https://doi.org/10.1177/0269881104040248
https://doi.org/10.1177/0269881104040248
Publikováno v:
Diabetes technologytherapeutics. 16(8)
Because insulin dosing requires optimization of glycemic control, it is important to use a single metric of benefit and risk to determine best insulin dosing practices. We retrospectively applied a multiplicative clinical utility index (CUI) to a stu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::07c60e6ec6eb8525620566cb558ac11b
https://pubmed.ncbi.nlm.nih.gov/24825416
https://pubmed.ncbi.nlm.nih.gov/24825416