Zobrazeno 1 - 10
of 25
pro vyhledávání: '"Richard C. Walovitch"'
Autor:
Guenther Brueggenwerth, Richard C. Walovitch, Colin G Miller, Klaus Noever, Robert Ford, David L. Raunig, Annette Schmid, Ivalina Hristova, Michael O'Neal, Michael O’Connor
Publikováno v:
Therapeutic Innovation & Regulatory Science. 55:1122-1138
Though many clinical trials rely on medical image evaluations for primary or key secondary endpoints, the methods to monitor reader performance are all too often mired in the legacy use of adjudication rates. If misused, this simple metric can be mis
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1c7d1004904d22c1a6eaac839912d3ff
https://doi.org/10.1007/s43441-021-00317-5
https://doi.org/10.1007/s43441-021-00317-5
Autor:
Colin G Miller, Liz Kuney, Michael O’Connor, Richard C. Walovitch, Annette Schmid, Robert W. Ford, Josy Breuer, Robert Ford, Guenther Brueggenwerth, David L. Raunig
Publikováno v:
Therapeutic Innovation & Regulatory Science
The debate over human visual perception and how medical images should be interpreted have persisted since X-rays were the only imaging technique available. Concerns over rates of disagreement between expert image readers are associated with much of t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a6681f8527778526cd59b6e3491cda7a
https://doi.org/10.1007/s43441-021-00316-6
https://doi.org/10.1007/s43441-021-00316-6
Autor:
David L, Raunig, Annette M, Schmid, Colin G, Miller, Richard C, Walovitch, Michael, O'Connor, Klaus, Noever, Ivalina, Hristova, Michael, O'Neal, Guenther, Brueggenwerth, Robert R, Ford
Publikováno v:
Therapeutic innovationregulatory science. 55(6)
Though many clinical trials rely on medical image evaluations for primary or key secondary endpoints, the methods to monitor reader performance are all too often mired in the legacy use of adjudication rates. If misused, this simple metric can be mis
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::be35059b4cb435e51f63375cab9be1fe
https://pubmed.ncbi.nlm.nih.gov/34244987
https://pubmed.ncbi.nlm.nih.gov/34244987
Autor:
Richard C. Walovitch
Publikováno v:
Clinical Research and Regulatory Affairs. 30:33-37
The FDA has recently issued a draft Guidance Standard for Clinical Trial Imaging Endpoints, which focuses on how to perform registration trials with imaging as an end-point or using imaging to determine patient eligibility. Leading up to the release
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4117e2b34948fac1f1569226dce1a986
https://doi.org/10.3109/10601333.2013.812109
https://doi.org/10.3109/10601333.2013.812109
Publikováno v:
Biomarkers in Medicine. 6:839-847
The current cost of developing a successful drug is typically over a billion dollars, with the registration trial(s) determining the success or failure of the entire development program. Often the primary endpoint of these trials is a subjective asse
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8bb0e7cdf98cefc8695564df36e062d1
https://doi.org/10.2217/bmm.12.74
https://doi.org/10.2217/bmm.12.74
Autor:
Asli Memisoglu, Janet Wittes, Ami E Iskandrian, Sanjiv Kaul, Thomas R Porter, Roxy Senior, Mark J Monaghan, James E Udelson, Richard C Walovitch, Michael H Picard
Publikováno v:
Circulation. 118
Introduction RAMP (Realtime Assessment of Myocardial Perfusion Imaging) 1 and 2 showed that coronary artery disease (CAD) diagnosis with perfusion stress echocardiography (PSE) and perflubutane polymer microspheres in chest pain patients is as accura
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b41c9e943bb2212070e5c58a3b0c0280
https://doi.org/10.1161/circ.118.suppl_18.s_934
https://doi.org/10.1161/circ.118.suppl_18.s_934
Publikováno v:
International Journal of Radiation Applications and Instrumentation. Part B. Nuclear Medicine and Biology. 17:77-83
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e5fd7f96b33db412d64625b7746b7eb9
https://doi.org/10.1016/0883-2897(90)90011-o
https://doi.org/10.1016/0883-2897(90)90011-o
Autor:
Muralidhar Beeram, David Tuck, Eric K. Rowinsky, Alain C. Mita, Richard C. Walovitch, Cecilia Simmons, Lionel D. Lewis, Anne J. Stone, Anthony J. Olszanski, Kathleen Mackay, Susan Hammond, Monica M. Mita, Raymond P. Perez
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research. 13(11)
Purpose: AI-850, paclitaxel in a novel polyoxyethylated castor oil-free hydrophobic microparticle delivery system, is being developed based on its favorable preclinical safety and antitumor activity profiles. The objectives of the study were to asses
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31ee17d386ddadb36e8970e5a966b7d5
https://pubmed.ncbi.nlm.nih.gov/17545535
https://pubmed.ncbi.nlm.nih.gov/17545535
Autor:
Karen Y. Ong, Richard C. Walovitch, Zoltan Tyeklar, Katarina Midelfort, Huillori S. Ouellet, Hironao Sajiki, Erin M. Buchanan, Paul J. Bernard, David J. Parmelee, Daniel M. Scott, Thomas J. McMurry, Randall B. Lauffer, Robert P. Dolan
Publikováno v:
Academic Radiology. 3:S356-S358
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9757284a1acab2a4cba7d79cfd272d41
https://doi.org/10.1016/s1076-6332(96)80583-6
https://doi.org/10.1016/s1076-6332(96)80583-6